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MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 31st January, 2017
G.S.R. 78(E). — WHEREAS the draft of the Medical Devices Rules, 2016 was published, as required under sub-section (1) of Section 12 and Sub-section (1) of Section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), in the Gazette of India, Extraordinary, Part II, section 3, sub-section (i), vide notification number G.S.R. 983(E), dated the 17th^ October, 2016, by the Central Government, after consultation with the Drugs Technical Advisory Board, inviting objections and suggestions from all persons likely to be affected thereby, before the expiry of a period of thirty days from the date on which copies of the said Gazette containing the said notification were made available to the public;
AND WHEREAS , copies of the Gazette containing the said notification were made available to the public on the 17th October, 2016;
AND WHEREAS , all objections and suggestions received in response to the said draft notification have been duly considered by the Central Government;
NOW, THEREFORE, in exercise of the powers conferred by section 12 and section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board, hereby makes the following rules, namely,-
CHAPTER I
PRELIMINARY
1. Short title and commencement.— (1) These rules may be called the Medical Devices Rules, 2017. (2) These rules shall, unless specified otherwise, come into force with effect from 1st^ day of January, 2018. 2. Application.— These rules shall be applicable in respect of,- (i) substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood and blood component collection bag with or without anticoagulant covered under sub-clause (i); (ii) substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and insecticides notified under sub-clause (ii); and (iii) devices notified from time to time under sub-clause (iv), of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940); 3. Definitions.— In these rules, unless the context otherwise requires,- (a) “academic clinical study” means a clinical study conducted for academic purpose on a medical device for the approved or a new intended use, new material of construction, new improved design or new population; (b) “Act” means the Drugs and Cosmetics Act, 1940 (23 of 1940); (c) "active diagnostic medical device" means any active medical device used, whether alone or in combination with other medical devices, to supply information for detecting, diagnosing or monitoring, or to provide support in the treatment of, any physiological condition, state of health, illness or congenital deformity; (d) “active medical device” means a medical device, the operation of which depends on a source of electrical energy or any other source of energy other than the energy generated by human or animal body or gravity; (e) “active therapeutic medical device" means any active medical device used, whether alone or in combination with any other medical device, to support, modify, replace or restore biological functions or structures, with a view to the treatment or alleviation of any illness, injury or handicap; (f) “authorised agent” means a person including any firm or organisation who has been appointed by an overseas manufacturer through a power of attorney to undertake import of medical device in India;
(g) “body orifice” means any natural opening in a human body including the external surface of any eyeball, or any permanent artificial opening, such as a stoma or permanent tracheotomy; (h) “Central Licensing Authority” means the Drugs Controller General of India appointed by the Central Government; (i) “central medical devices testing laboratory” means a medical devices laboratory established or designated by the Central Government under rule 19 and shall be deemed to be a Central Drug Laboratory established for the purpose of section 6 of the Act; (j) “change in the constitution of a licencee” in relation to,-
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(i) a firm means change from proprietorship to partnership including Limited Liability Partnership or vice versa ; (ii)a company means- (A) its conversion from a private to a public company, or from a public to a private company; or (B) any change in the ownership of shares of more than fifty per cent. of the voting capital in the body corporate or in case of a body corporate not having a share capital, any change in its membership; and where the managing agent, being a body corporate is a subsidiary of another body corporate, includes a change in the constitution of that other body corporate within the meaning of this clause; (k) “clinical evidence” means, in relation to,- (i) an in vitro diagnostic medical device, is all the information derived from specimen collected from human that supports the scientific validity and performance for its intended use; (ii) a medical device, the clinical data and the clinical evaluation report that supports the scientific validity and performance for its intended use; (l) “clinical investigation” means the systematic study of an investigational medical device in or on human participants to assess its safety, performance or effectiveness; (m) “clinical investigation plan” means a document which contains the information about the rationale, aims and objective, design and the proposed analysis, conduct, methodology including performance, management, adverse event, withdrawal and statistical consideration and record keeping pertaining to clinical investigation; (n) “clinical performance evaluation” means the systematic performance study of a new in vitro diagnostic medical device on a specimen collected from human participants to assess its performance; (o) “clinical research organisation” means any entity to whom a sponsor may transfer or delegate one or more of its functions and duties regarding conduct of clinical investigation or clinical performance evaluation; (p) “conformity assessment” means the systematic examination of evidence generated and procedures undertaken, by the manufacturer to determine that a medical device is safe and performs as intended by the manufacturer and therefore conforms to the essential principles of safety and performance for medical devices; (q) “controlling officer” means the officer designated under rule 10; (r) “custom made medical device” means a medical device made specifically in accordance with a written prescription of a registered medical practitioner, specialised in the relevant area, under his responsibility for the sole use of a particular patient, but does not include a mass production of such device; (s) “Ethics Committee” means the committee referred to in rule 50; (t) “Form” means forms specified in Appendix to these rules; (u) “Good Clinical Practices Guidelines” means Good Clinical Practices Guidelines issued by Central Drugs Standards Control Organisation, Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India; (v) “intended use” means the use for which the medical device is intended according to the data supplied by the manufacturer on the labelling or in the document containing instructions for use of such device or in promotional material relating to such device, which is as per approval obtained from the Central Licensing Authority; (w) “invasive device” means a device which, in whole or part, penetrates inside the body, either through a body orifice or through the surface of the body; (x) “investigational medical device” in relation to a medical device, other than in vitro diagnostic medical device, means a medical device specified in clause (zb),- (i) which does not have its predicate device as defined in clause (zm); or (ii) which is licenced under sub-rule (4) or sub-rule (6) of rule 20, sub-rule (1) of rule 25, or sub-rule (1) of rule 36 and claims for new intended use or new population or new material or major design change; and is being assessed for safety or performance or effectiveness in a clinical investigation. (y) “licence” means a licence granted by the State Licensing Authority or the Central Licensing Authority in Form MD-5, Form MD-6, Form MD-9, Form MD-10, Form MD-15, Form MD-17 or Form MD-19 as the case may be; (z) “loan licence” means a licence issued for manufacturing a medical device by the State Licensing Authority or the Central Licensing Authority, as the case may be, to a person who intends to utilise the manufacturing site of other licencee for manufacturing the same medical device as manufactured by the licencee at that site; (za) “long term use” means intended continuous use of a medical device for more than thirty days; (zb) “medical device” means,- (A) substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood and blood component collection bag with or without anticoagulant covered under sub-clause (i), (B) substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and insecticides notified in the Official Gazette under sub-clause (ii), (C) devices notified from time to time under sub-clause (iv), of clause (b) of section 3 of the Act; Explanation : For the purpose of these rules, substances used for in vitro diagnosis shall be referred as in vitro diagnostic medical device.
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CHAPTER II REGULATION OF M EDICAL DEVICE.
4. Classification of medical devices.— (1) Medical devices other than in vitro diagnostic medical devices shall be classified on the basis of parameters specified in Part I of the First Schedule, in the following classes, namely: —
(i) low risk - Class A;
(ii) low moderate risk- Class B;
(iii) moderate high risk- Class C;
(iv) high risk- Class D.
(2) In vitro diagnostic medical devices shall be classified on the basis of parameters specified in Part II of the First Schedule , in the following classes, namely: —
(i) low risk - Class A;
(ii) low moderate risk- Class B;
(iii) moderate high risk- Class C;
(iv) high risk- Class D.
(3) The Central Licencing Authority shall, classify medical devices referred to in rule 2, based on the intended use of the device and other parameters specified in the First Schedule. (4) Based on the classification referred to in sub-rule (3), class wise list of medical devices shall be published on the website of the Central Drugs Standard Control Organisation: Provided that the Central Licencing Authority may, from time to time, make additions or deletions in such list of medical devices or modify the class of any medical device.
5. Medical device grouping.— Any person who intends to apply for grant of licence in respect of medical devices for,- (i) import; (ii) manufacture for sale or for distribution; and (iii) sale, stock, exhibit or offer for sale, may group all or any medical device in accordance with the guidelines to be issued from time to time by the Ministry of Health and Family Welfare in the Central Government, by taking into consideration the technological changes or development in the field of medical devices and in vitro diagnostic medical devices. 6. Essential principles for manufacturing medical devices.— Medical device manufacturer shall follow the essential principles of safety and performance of medical devices as may be specified in the guidelines issued by the Ministry of Health and Family Welfare in the Central Government, from time to time keeping in view the contemporary scientific and technological knowledge and development: Provided that the guidelines to be so specified shall be in conformity with the provisions of the Act and these rules. 7. Product standards for medical device.— (1) The medical device shall conform to the standards laid down by the Bureau of Indian Standards established under section 3 of the Bureau of Indian Standards Act, 1985 (63 of 1985) or as may be notified by the Ministry of Health and Family Welfare in the Central Government, from time to time. (2) Where no relevant Standard of any medical device has been laid down under sub-rule (1), such device shall conform to the standard laid down by the International Organisation for Standardisation (ISO) or the International Electro Technical Commission (IEC), or by any other pharmacopoeial standards. (3) In case of the standards which have not been specified under sub-rule (1) and sub-rule (2), the device shall conform to the validated manufacturer’s standards.
CHAPTER III
A UTHORITIES, O FFICERS AND B ODIES.
8. Licensing Authorities.— (1) The Central Licensing Authority shall be the competent authority for enforcement of these rules in matters relating to,- (i) import of all Classes of medical devices; (ii) manufacture of Class C and Class D medical devices; (iii) clinical investigation and approval of investigational medical devices; (iv) clinical performance evaluation and approval of new in vitro diagnostic medical devices and; (v) co-ordination with the State Licensing Authorities. (2) The State Drugs Controller, by whatever name called, shall be the State Licensing Authority and shall be the competent authority for enforcement of these rules in matters relating to,- (i) manufacture for sale or distribution of Class A or Class B medical devices; (ii) sale, stock, exhibit or offer for sale or distribution of medical devices of all classes.
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9. Delegation of powers of Licensing Authorities.— (1) The Central Licensing Authority, may with the prior approval of the Central Government, by an order in writing, delegate all or any of its powers to any other officer of the Central Drugs Standard Control Organisation not below the rank of Assistant Drugs Controller. (2) The officer to whom the powers have been delegated under sub-rule (1) shall exercise the powers of the Central Licensing Authority under its name and seal. (3) The State Licensing Authority, may, with the prior approval of the State Government, by an order in writing, delegate all or any of its powers to any officer under its control. (4) The officer to whom the powers have been delegated under sub-rule (3) shall exercise the powers of the State Licensing Authority under its name and seal. 10. Controlling officer.— Any officer not below the rank of Assistant Drugs Controller, by whatever name called, shall be the controlling officer to supervise and give instructions to any officer subordinate to such controlling officer to exercise powers and functions under these rules for areas and purposes specified, by an order, of the Drugs Controller General of India or the Drugs Controller, by whatever name called, of the State concerned. 11. National Accreditation Body.— (1) The Central Government may, by notification, designate such institute, firm or a Government aided or Government organisation, which fulfills the criteria specified from time to time by the Government, as the National Accreditation Body: Provided that the National Accreditation Board for Certification Bodies under the Quality Council of India, registered under the Societies Registration Act, 1860 (21 of 1860) set up by the Ministry of Commerce and Industry in the Government of India shall act as the National Accreditation Body for the purposes of accrediting Notified Bodies referred to in rule 13, till such time any other body for the purpose is notified, with immediate effect. (2) The National Accreditation Body shall have the required number of competent persons for proper performance of its functions (3)The designated National Accreditation Body referred to in sub-rule (1) shall be responsible for carrying out the assessment of such entities who may apply for accreditation to become a Notified Body for the purpose of these rules. (4) The National Accreditation Body referred to in sub-rule (1), shall, after carrying out the assessment of the entity which applied for accreditation, issue a certificate to such entity in respect of specified categories of standards for which such entity has been assessed and found qualified: Provided that where the entity has been found not possessing the requisite qualification and other requirements, the National Accreditation Body, shall reject the application. (5) The National Accreditation Body shall not act as a Notified Body. 12. Functions of National Accreditation Body.— The National Accreditation Body shall,-
(a) lay down the conformity assessment activities for accreditation of Notified Bodies and lay down standards
for such accreditation;
(b) prepare norms and procedures for accreditation of Notified Body;
(c) audit a Notified Body periodically for assessing conformance with these rules and the norms laid down by
it.
13. Notified body.— (1) Any institute, organisation or body corporate may seek accreditation, after notification of these rules, as a Notified Body by applying to the National Accreditation Body referred to in rule 11 in such form and manner as may be determined by the National Accreditation Body from time to time. (2) The Notified Body accredited under sub-rule (1) shall be competent to carry out audit of manufacturing sites of Class A and Class B medical devices to verify conformance with the Quality Management System and other applicable standards as specified under these rules in respect of such medical devices as and when so advised by the State Licensing Authority. (3) Any Notified Body accredited under sub-rule (1) shall, if it intends to carry out audit of a manufacturing site of Class A or Class B of medical devices in accordance with sub-rule (2), register with the Central Licensing Authority. (4) Any Notified Body under sub-rule (3), with an experience of at least two years, may apply to the Central Licensing Authority for registration as a Notified Body for carrying out audit of Class C and Class D medical devices, provided it has personnel with requisite qualification and experience. (5) With effect from the 1 st day of the July, 2017, the Notified Body accredited in accordance with sub-rule (3) may make an application to the Central Licensing Authority for registration in Form MD-1 through online portal accompanied with a fee specified in the Second Schedule along with documents as specified in Part I of the Third Schedule. (6) The Central Licensing Authority, on being satisfied, shall register the Notified Body and issue a registration certificate in Form MD-2. (7) The Registration Certificate shall remain valid in perpetuity, unless, it is suspended or cancelled, provided the registration certificate holder deposits a registration retention fee as specified in the Second Schedule every five years from the date of its issue.
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Family Welfare in the Central Government in Form MD-3 for licence or in Form MD-4 for loan licence accompanied with a fee, as specified in the Second Schedule along with respective documents as specified in Part II of the Fourth Schedule. (3) The application made under sub-rule (1), shall, amongst others, be accompanied with an undertaking to the effect that the requirements of Quality Management System as specified in the Fifth Schedule have been complied with. (4) The State Licensing Authority shall, after scrutiny of documents and on being satisfied that the requirements of these rules have been complied with, grant a licence to manufacture Class A medical devices in Form MD-5 or loan licence in Form MD-6, as the case may be, or if not satisfied, reject the application for reasons to be recorded in writing, within forty five days from the date, the application is made under sub-rule (1). Provided that, — (i) no audit of the manufacturing site shall be necessary prior to grant of licence or loan licence to manufacture for sale or for distribution of Class A medical device; and (ii) the required audit of such manufacturing site by the registered Notified Body in the manner as specified in the Third Schedule shall be carried out within one hundred and twenty days from the date on which the licence was granted by the State Licencing Authority. (5) Manufacturing site of the applicant, in respect of Class B device, shall conform to the requirements of Quality Management System as specified under the Fifth Schedule and applicable standards as specified under these rules and such conformance shall be verified through an audit by a Notified Body as referred under rule 13 before grant of licence. (6) In case of application for grant of licence or loan licence to manufacture for sale or for distribution of Class B medical devices, — (i) the audit of the manufacturing site shall be carried out within ninety days from the date of application by the registered Notified Body in the manner specified in the Third Schedule; (ii) the Notified Body shall furnish its report to the State Licensing Authority within thirty days of the completion of audit; (iii) the State Licensing Authority shall, after scrutiny of documents, audit report as referred to in clause (ii) and on being satisfied that the requirements of these rules have been complied with, grant a licence to manufacture Class B medical devices in Form MD-5 or loan licence in Form MD-6, as the case may be, or if not satisfied, reject the application for reasons to be recorded in writing, within a period of twenty days from the date of receipt of the report of audit by the Notified Body. (7) If the application for grant of licence or loan licence to manufacture for sale or for distribution is rejected under sub-rule (4) or sub-rule (6), the aggrieved person may file an appeal before the State Government within forty-five days from the date of receipt of such rejection, which may, after such enquiry and after giving an opportunity of being heard to the appellant, be disposed of within a period of sixty days. (8) Where the Central Licensing Authority or the State Licensing Authority has reason to believe or it has been alleged or suspected that the medical device does not conform to the standards of quality, or the provisions of the Fifth Schedule are not complied with, the State licensing Authority, in case of Class A or Class B medical device, or the Central Licensing Authority, in case of any Class of medical device, may direct a team of officers referred to in rule 23 to cause inspection of licenced manufacturing site.
21. Application for manufacturing Class C or Class D devices.— (1) An application shall be made to the Central Licensing Authority through an identified online portal of the Central Government for licence or loan licence to manufacture for sale or for distribution, as the case may be, of Class C or Class D medical device in Form MD-7 or Form MD-8, respectively. (2) The application in Form MD-7 or Form MD-8 referred to in sub-rule (1) relating to Class C or Class D medical device, as the case may be, shall be accompanied with a fee as specified in the Second Schedule along with documents as specified in clause (ii) of Part II of the Fourth Schedule. (3) The Central Licensing Authority may, wherever required, in case of Class C or Class D medical devices, use the services of any expert in the relevant field for scrutiny of application and other technical documents. (4) The scrutiny referred to in sub-rule (3) shall be completed by the Central Licensing Authority within a period of forty five days from the date of online submission of application. (5) In case, where the documents are found to be complete and in order, the Central Licensing Authority shall cause an inspection of the manufacturing site carried out under rule 23 by a team of officers accompanied by such experts, as may be considered necessary. (6) The Central Licensing Authority may, where required, avail the services of a Notified Body referred to in sub-rule (4) of rule 13 for inspecting the manufacturing site of Class C and Class D medical devices. (7) In case, where the documents furnished with the application referred to in sub-rule (1) are not found to be complete and in order, the Central Licensing Authority shall reject the application and inform the applicant of the reasons for such rejection electronically: Provided that where deficiencies that can be rectified, are pointed out by the Central Licensing Authority within the stipulated period, the period referred to in sub-rule (4) shall reckon from the date these deficiencies have been removed.
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22. Requirements for grant of manufacturing licence or loan licence.— While making application for grant of licence or loan licence under rule 20 or rule 21, the applicant shall meet the following requirements, namely: — (i) the manufacturing site shall comply with the requirements of the Quality Management System as specified under the Fifth Schedule ; (ii) appoint competent technical staff under whose direction and supervision the manufacturing activity of a medical device shall be undertaken and such staff shall possess the following educational qualification and experience,- (a) degree in engineering in relevant branch or in pharmacy or in science in appropriate subject from a recognised University and shall have experience of not less than two years in manufacturing or testing of medical devices; or (b) diploma in engineering (in relevant branch) or in pharmacy from a recognised institute and shall have the experience of not less than four years in manufacturing or testing of medical devices; (iii) appoint competent technical staff with degree or diploma in engineering (in relevant branch) or in pharmacy or in science in relevant subject and having experience of not less than two years in testing of medical devices under whose direction and supervision, the testing activity of a medical device shall be undertaken. 23. Inspection for grant of licence or loan licence for Class C or Class D medical device.— (1) Before grant of licence to manufacture for sale or for distribution in respect of Class C or D medical device, the manufacturing site shall be inspected within a period of sixty days from the date of application by a team comprising not less than two Medical Device Officers which may include any officer senior to the Medical Device Officer with or without an expert, or a Notified Body referred to in sub-rule (4) of rule 13: Provided that no inspection of a medical device manufacturing site for grant of loan licence to manufacture such medical device shall be required to be carried out if the manufacturing site is already licenced to manufacture such medical device for sale or for distribution. (2) The composition of the inspection team referred to in sub-rule (1) shall be determined by the controlling officer and no inspection shall be carried out without prior approval of the controlling officer. 24. Inspection report.— After completion of inspection as referred to in rule 23, the inspection team shall forward a descriptive report containing findings on each aspect of inspection along with the recommendations to the Central Licensing Authority, through online portal of the Ministry of Health and Family Welfare in the Central Government and forward a copy of the same to the applicant. 25. Grant of licence or loan licence to manufacture for sale or for distribution.— (1) If the Central Licensing Authority, after receipt of the report as referred to in rule 24, and such further enquiry, if any, as may be considered necessary, is satisfied that the requirements of these rules have been complied, that Authority shall grant a licence in Form MD-9, or loan licence in Form MD-10 or may reject the application for reasons to be recorded in writing, within a period of forty five days from the date the inspection report has been received. (2) If the application for grant of licence or loan licence to manufacture for sale or for distribution is rejected under sub-rule (1), the aggrieved person may file an appeal before the Central Government within forty five days from the date of receipt of such rejection, which may, after such enquiry and after giving an opportunity of being heard to the appellant, be disposed of within a period of sixty days. (3) In case, a licencee or loan licencee intends to manufacture additional medical devices in the licensed manufacturing site, the manufacturer shall make an application for grant of permission to manufacture such medical devices to the Central Licensing Authority or State Licensing Authority, as the case may be, along with the fee as specified in the Second Schedule and the documents as referred to in rule 20 or rule 21, as the case may be. (4) In case of investigational medical device or new in vitro diagnostic medical device, the applicant shall obtain prior permission in Form MD-27 or Form MD-29 from the Central Licensing Authority and no licence to manufacture any class of such medical device shall be granted without such permission. 26. Conditions for manufacturing licence or loan licence.— After grant of licence or loan licence in Form MD-5, Form MD-6, Form MD-9 or MD-10, as the case may be, the licence holder shall comply with the following conditions, namely:- (i) licence shall be produced when requested by the Medical Device Officer or any other senior officer under the control of Central Licensing Authority or State Licensing Authority, as the case may be; (ii) the licence holder shall inform the State Licensing Authority or the Central Licensing Authority, as the case may be, of the occurrence of any suspected unexpected serious adverse event and action taken thereon including any recall within fifteen days of such event coming to the notice of licence holder; (iii) the licence holder shall obtain prior approval from the Central Licensing Authority or the State Licensing Authority, as the case may be, before any major change as specified in the Sixth Schedule is carried out and the Central Licensing Authority or the State Licensing Authority, as the case may be, shall indicate its approval or rejection within forty five days and in case where no communication is received within the stipulated time from
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(3) The State Licensing Authority or the Central Licensing Authority, as the case may be, may revoke suspension order issued under sub-rule (2) for reasons to be recorded in writing.
(4) Orders of suspension issued or revoked; or cancellation of licence shall be duly published on the concerned websites of the State Licensing Authority or the Central Licensing Authority, as the case may be.
31. Test licence to manufacture for test, evaluation, clinical investigations, etc.,— (1) Small quantity of Class A or Class B or Class C or Class D of medical devices may be manufactured for the purpose of clinical investigations, test, evaluation, examination, demonstration or training for which an application shall be made in Form MD-12 to the Central Licensing Authority and shall be accompanied with a fee as specified in the Second Schedule. (2) The application made under sub-rule (1) shall also be accompanied with the following documents, namely: — (a) brief description of the medical device including intended use, material of construction, design and an undertaking stating that the required facilities including equipment, instruments, and personnel have been provided to manufacture such medical devices; (b) list of equipment, instruments; (c) list of qualified personnel; (d) copy of manufacturing licence issued under these rules, if any; (e) approval letter authorising to undertake research and development activities issued by any Government organisation, if any. (3) The Central Licensing Authority, after enquiry, if any, as may be considered necessary, on being satisfied that the requirements of these rules have been complied, shall grant a test licence in Form MD-13, or may reject the application for reasons to be recorded in writing, within a period of thirty days from the date the application is made under sub-rule (1). (4) The licencee shall maintain a record of the details of quantity of the product manufactured under test licence. (5) A licence granted under sub-rule (3) shall, unless cancelled earlier, remain in force for a period of three years from the date of its issuance. 32. Conditions of test licence to manufacture for test, evaluation, clinical investigations, etc.,— A licence in Form MD-13 under rule 31 shall be subject to the following conditions, namely: — (a) the licencee shall use the medical device manufactured under licence granted under sub-rule (3) of rule 31 exclusively for the purpose of clinical investigations, test, evaluation, examination, demonstration or training at the place specified in the licence; (b) the licencee shall allow any Medical Device Officer to enter, with or without notice, the premises where the medical device are manufactured and to satisfy himself that only clinical investigations, test, evaluation, examination, demonstration or training is being conducted on such device; (c) the licencee shall maintain a record of the quantity of medical device manufactured, tested and stocked and its disposition. 33. Cancellation of test licence to manufacture for test, evaluation, clinical investigations, etc.,— (1) Where any licencee under rule 31 contravenes any provision of these rules, the Central Licensing Authority, shall, issue a show cause notice to such licencee asking, as to why an order should not be made to cancel the licence. (2) The Central Licensing Authority shall, after giving an opportunity to the licencee to explain in writing licencee’s defence, pass an order for cancellation or otherwise and record the reasons therefor in the said order. (3) A licencee, whose licence has been cancelled, may appeal to the Central Government within forty five days from the date of the order.
C HAPTER V
IMPORT OF M EDICAL DEVICES
34. Application for grant of import licence.— (1) An authorised agent having licence to manufacture for sale or distribution or wholesale licence for sale or distribution under these rules, shall make an application for grant of import licence for medical device to the Central Licensing Authority through an identified online portal of the Ministry of Health and Family Welfare in the Central Government in Form MD-14 for obtaining a licence. (2) The application under sub-rule (1) shall be accompanied with the fee as specified in the Second Schedule along with respective documents as specified in the Fourth Schedule: Provided that any change in the documents submitted at the time of application and prior to grant of licence shall be informed, in writing, to the Central Licensing Authority. (3) Where the Central Licensing Authority, has reason to believe that the quality of the medical device is compromised, and decides to subject it to evaluation, test or examination, the authorised agent shall pay a fee for such evaluation, test or examination, to the testing laboratory as specified by the Central Licensing Authority. (4) Any subsequent application for,- (i) grant of licence for additional manufacturing site for the same medical device by the same authorised agent
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shall be accompanied with a fee and documents as referred in sub-rule (2); (ii) licence for additional medical device manufactured at the same manufacturing site shall be made by the same authorised agent accompanied with fee as specified in the Second Schedule and respective documents as specified in the Fourth Schedule.
35. Inspection of overseas manufacturing site.— (1) On receipt of an application under sub-rule (1) of rule 34, the Central Licensing Authority, may cause an inspection of the overseas manufacturing site either by itself or by any other person or body to whom the power has been delegated for the purpose. (2) The applicant shall be liable to pay a fee as specified under the Second Schedule in respect of expenditure required in connection with the visit to the overseas manufacturing site under sub-rule (1). 36. Grant of import licence.— (1) After examination of documents furnished with the application under sub-rule (1) of rule 34 and on the basis of the inspection report, if inspection has been carried out, the Central Licensing Authority may, on being satisfied, grant licence in Form MD-15 or, may reject such application for which reasons shall be recorded in writing, within a period of nine months from the date of application. (2) In the event of rejection, the applicant may appeal to the Central Government within a period of forty five days and that Government, may, after such enquiry into the matter, as considered necessary, pass orders in relation thereto within a period of ninety days from the date of appeal. (3) Where, a free sale certificate has already been issued in respect of any medical device by the national regulatory authority or other competent authority of any of the countries namely, Australia, Canada, Japan, European Union Countries, or the United States of America, a licence shall be granted under sub-rule (1) to the applicant without carrying out clinical investigation. (4) Where a medical device is imported from countries other than those referred to in sub-rule (3), the licence in case of Class C and Class D medical devices may be granted after its safety and effectiveness has been established through clinical investigation in India as specified under provisions of Chapter VII of these rules. (5) Where a medical device, is imported from countries other than those referred to in sub-rule (3), the licence in case of Class A or Class B medical devices may be granted after its safety and performance has been established through published safety and performance data or through clinical investigation in the country of origin and a free sale certificate from the country of origin is furnished. (6) In case of investigational medical device or new in vitro diagnostic medical device, the applicant shall obtain prior permission in Form MD-27 or in Form MD-29 from the Central Licensing Authority and no licence to import any class of such medical device shall be granted without such permission. 37. Validity of licence.— A licence granted under sub-rule (1) of rule 36 shall remain valid in perpetuity, unless, it has been cancelled or surrendered, provided the authorised agent deposits the licence retention fee with the Central Licensing Authority as specified in the Second Schedule for each overseas manufacturing site and for each licenced medical device after completion of every five years from the date of its issue: Provided that the Central Licensing Authority may permit to deposit the licence retention fee after due date but before expiry of ninety days with a late fee calculated at the rate of two per cent. per mensem: Provided further that if the licencee fails to deposit the licence retention fee within the above stipulated period, the licence shall be deemed to have been cancelled. 38. Conditions to be complied with by Licence holder.— (1) The licencee shall comply with the following conditions, namely:- (i) licence shall be produced when requested by the Medical Device Officer or any other senior officer under the control of Central Licensing Authority or the State Licensing Authority, as the case may be; (ii) the licencee shall inform the licensing authority forthwith and, in all circumstances, within a period of fifteen days of any administrative action taken on account of any adverse reaction, such as market withdrawal, regulatory restrictions, cancellation of authorisation or declaration of the medical device as not of standards quality by the regulatory authority of the country of origin or by any regulatory authority of any other country, where the medical device is marketed, sold or distributed; (iii) authorised agent in cases referred in clause (ii), shall stop immediately the despatch and marketing of the medical device referred in that clause; (iv) the Central Licensing Authority, after due consideration of the information as referred in clause (ii), may issue directions to the licencee in respect of marketing, sale or distribution of the medical device including withdrawal of medical device from the Indian market within a period as may be specified by the Central Licensing Authority; (v) the authorised agent shall obtain prior approval from the Central Licensing Authority before any major change, as specified in the Sixth Schedule, is carried out and the Central Licensing Authority shall indicate its approval or rejection within sixty days; (vi) in case, no communication of approval or rejection as referred to in clause (v) is received within the stipulated time from the Central Licensing Authority, such change shall be deemed to have been approved; (vii) licencee shall inform, any minor change as specified in the Sixth Schedule to the Central Licensing Authority
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(2) On receipt of an application under sub-rule (1), the Central Licensing Authority shall, on being satisfied about the information and the documents enclosed with the application, grant import licence for treatment of patient in Form MD-19. (3) The medical device for which the licence is granted under sub-rule (2), shall, be used exclusively for the purpose of treatment of the patient referred to in sub-rule (1). (4) The holder of licence shall maintain record of the name of the manufacturer, quantity imported and used, date of import, name and address of the patient and diagnosis. (5) The holder of the licence shall allow the medical device officer authorised by the Central Licensing Authority in this behalf to enter, with or without prior notice, the premises where the medical devices are stocked and to inspect the premises and relevant records and investigate the manner in which the medical device is being used and to take, if required, samples thereof. (6) The quantity considered necessary shall be determined by the Central Licensing Authority after taking into account the recommendation of the hospital concerned for treatment of patient suffering from a life threatening disease or disease causing serious permanent disability or disease requiring therapy for unmet medical need. (7) Where the Central Licensing Authority is satisfied, it may, in exceptional and special circumstances, allow import of larger quantity of medical devices for use by the patient. (8) The consignment of medical device shall be accompanied by an invoice or a statement showing the name and quantity of medical device.
43. Import of medical device for personal use.— (1) Small quantity of medical device, the import of which is otherwise prohibited under section 10 of the Act, may be imported for personal use subject to the following conditions, namely,- (i) the medical device shall form part of a personal baggage of a passenger and be intended for the exclusive use of such passenger; (ii) the medical device shall be declared as personal baggage of the passenger to the customs authorities, if they so direct; (iii) the quantity of any single medical device so imported shall not exceed the quantity specified by the registered medical practitioner; (iv) the medical device has been prescribed by a registered medical practitioner; and (v) the medical device so imported shall be accompanied with an invoice or a statement showing the name and quantity of medical device. (2) Small quantity of medical device, the import of which is otherwise prohibited under section 10 of the Act, and which is not forming a part of bona fide personal baggage, may be imported for personal use, on an application made by the applicant in Form MD-20 and such application shall be accompanied by documents confirming that the device is for bona fide personal use and a prescription to that effect by a registered medical practitioner. (3) On receipt of an application under sub-rule (2), the Central Licensing Authority shall, on being satisfied about the information and the documents enclosed with the application, grant permission in Form MD-21 or may reject the application for reasons to be recorded in writing within a period of seven days from the date of application under sub- rule (2). (4) Medical devices as referred to in sub-rule (2) shall be subject to the following conditions, namely,- (i) the medical device shall be declared to the Customs Authorities if they so direct; (ii) the consignment of the medical device so imported shall be accompanied with an invoice or statement showing the name and quantity of medical device.
CHAPTER VI
L ABELLING OF M EDICAL DEVICES
44. Labelling of medical devices.— The following particulars shall be printed in indelible ink on the label, on the shelf pack of the medical device or on the outer cover of the medical device and on every outer covering in which the medical device is packed, namely,- (a) name of the medical device; (b) the details necessary for the user to identify the device and its use; (c) the name of manufacturer and address of manufacturing premises where the device has been manufactured; (d) the correct statement about the net quantity in terms of weight, measure, volume, number of units, as the case may be, and the number of the devices contained in the package expressed in metric system; (e) the month and year of manufacture and expiry (alternately the label shall bear the shelf life of the product): Provided that in case of sterile devices, the date of sterilization may be given as date of manufacture of the device: Provided further that where the device is made up of stable materials such as stainless steel or titanium, and supplied non-sterile or in case of medical equipment or instruments or apparatus, the date of expiry may not be necessary.
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Explanation****. - For the purposes of this clause, the date of expiry shall be in terms of the month and the year and it shall mean that the medical device is recommended till the last day of the month and the date of expiry shall be preceded by the words “Expiry date” or “Shelf Life”; (f) to provide, wherever required, an indication that the device contains medicinal or biological substance; (g) to provide, a distinctive batch number or lot number preceded by the word “Lot No.” or “Lot” or “Batch No.” or “B. No.”; (h) to indicate, wherever required, any special storage or handling conditions applicable to the device; (i) to indicate, if the device is supplied as a sterile product, its sterile state and the sterilisation method; (j) to give, if considered relevant, warnings or precautions to draw the attention of the user of medical device; (k) to label the device appropriately, if the device is intended for single use; (l) to overprint on the label of the device, the words “Physician’s Sample—Not to be sold”, if a medical device is intended for distribution to the medical professional as a free sample; (m) to provide, except for imported devices, the manufacturing licence number by preceding the words “Manufacturing Licence Number” or “Mfg. Lic. No.” or “M. L”; (n) to provide on the label, in case of imported devices, by way of stickering, where such details are not already printed, the import licence number, name and address of the importer, address of the actual manufacturing premises and the date of manufacture: Provided that the label may bear symbols recognised by the Bureau of Indian Standards or International Organisation for Standardisation (ISO) in lieu of the text and the device safety is not compromised by a lack of understanding on the part of the user, in case the meaning of the symbol is not obvious to the device user; (o) in case of small sized medical devices on which information cannot be printed legibly, shall include the information necessary for product identification and safety such as information covered by clauses (a), (b), (c), (d), (e), (g), (k), and (m) shall be included.
45. Exemption of labelling requirements for export of medical devices.— The labels on packages or container of devices for export shall be adopted to meet the specific requirements of law of the country to which the device is to be exported, but the following particulars shall appear in a conspicuous manner on the label of the inner most pack or shelf pack of the medical device in which the device is packed and every other outer covering in which the container is packed:- (a) name of the device; (b) the distinctive batch number or lot number or serial number preceded by the word “Lot No.” or “Lot” or “Batch No.” or “B. No.” or “Serial No.”; (c) date of expiry, if any; (d) the name and address of manufacturer and address of actual premises where the device has been manufactured; (e) licence number preceded by letters “Licence No. or Lic. No.”; (f) internationally recognised symbols in lieu of text, wherever required: Provided that where a device is required by the consignee not to be labeled with the name and address of manufacturer, the label on the package or container shall bear a code number as approved by the Central Licensing Authority and the code number shall bear the name of the State or Union territory, in abbreviation, followed by the word “Device” and “manufacturing licence number”: Provided further that where a device is required by the consignee not to be labeled with the code number also, the label on the packages or container shall bear a special code number, as requested by the consignee, and approved by the Central Licensing Authority. 46. Unique device identification of the medical device.— With effect from 1 st^ day of January, 2022, a medical device, approved for manufacture for sale or distribution or import, shall bear unique device identification which shall contain device identifier and production identifier. Explanation. — For the purposes of this rule,- (i) “device identifier” means a global trade item number;. (ii) “production identifier” means a serial number, lot or batch number, software as a medical device version, manufacturing and or expiration date. 47. Shelf life of medical devices.— The shelf life of the medical devices, shall be determined keeping in view the technical parameters and shall ordinarily not exceed sixty months from the date of manufacture to be reckoned from month to month (i.e. January to January), except in cases where satisfactory evidence is produced by the manufacturer to justify a shelf life of more than sixty months of a device to the satisfaction of the Central Licensing Authority:
Provided that any medical device, whose total shelf life claim is less than ninety days, shall not be allowed to be imported by the licensing authority if it has less than forty per cent. residual shelf-life on the date of import: Provided further that any medical device, whose total shelf life claim is between ninety days and one year, shall not be allowed to be imported by the licensing authority if it has less than fifty per cent. residual shelf-life on the date of import:
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53. Conditions for permission.— After grant of permission referred to in rule 52, the following conditions shall be complied with by the applicant, namely: — (i) clinical investigation shall be initiated after approval of clinical investigation plan by the registered Ethics Committee; (ii) clinical investigation shall be conducted in accordance with the approved clinical investigation plan, Good Clinical Practices Guidelines issued by the Central Drugs Standard Control Organisation and provisions of the Seventh Schedule; (iii) clinical investigation shall be registered with the Clinical Trial Registry of India before enrolling the first participant for such clinical investigation; (iv) annual status report of each clinical investigation, as to whether it is ongoing, completed or terminated, shall be submitted to the Central Licensing Authority by the sponsor, and, in case of termination of any clinical investigation, the detailed reasons for the same shall be communicated to the Central Licensing Authority within thirty days of such termination; (v) information about any report of suspected unexpected serious adverse event occurring during clinical investigation on the subject shall, after due analysis, be submitted by the sponsor to the Central Licensing Authority within fourteen days of the knowledge of its occurrence as specified in the Seventh Schedule and in compliance with the procedure specified in these rules; (vi) in case of an injury or death during clinical investigation of a subject of a clinical investigation, the applicant shall provide complete medical management or compensation in accordance with these rules; (vii) the premises of the sponsor including their employees, subsidiaries and branches, their agents, contractors and sub-contractors and clinical investigation sites shall be open for inspection by officers of the Central Licensing Authority who may be accompanied by officers of the State Licensing Authority or outside experts, to verify compliance of the requirements of these rules for conduct of clinical investigation; (viii) the clinical investigation shall be initiated by enrolling first participant within a period of one year from the date of grant of permission, failing which prior permission from the Central Licensing Authority shall be required to initiate clinical investigation; (ix) the Central Licensing Authority may impose or exempt any condition while granting permission in respect of specific clinical investigations, if considered necessary, regarding the objective, design, subject population, subject eligibility, assessment, conduct and treatment of clinical investigation. 54. Suspension, cancellation, etc. of permission.— (1) If any person to whom permission has been granted under rule 52 fails to comply with any of the conditions of permission or any of the provisions of the Act or these rules, the Central Licensing Authority may, — (a) issue warning letter giving details of deficiency found; or (b) debar the investigator or sponsor including their employees, subsidiaries and branches, their agents, contractors and sub-contractors to conduct any clinical investigation for such period as it thinks fit; or (c) suspend the permission for such period as it thinks fit or cancel either wholly or partly the permission. (2) Any person who is aggrieved by the order passed under sub-rule (1), may file an appeal within thirty days of the receipt of such order before the Central Government, which may, after such enquiry and after giving an opportunity of being heard to the appellant, dispose of the appeal within a period of sixty days. 55. Medical management and compensation related to clinical investigation.— (1) Where any participant is injured on account of participation in clinical investigation, the sponsor permitted under rule 52 shall provide medical management to that participant. (2) Where an injury is caused to the participant in a clinical investigation of any investigational medical device and such injury is attributable to the use of investigational medical device, the sponsor permitted under rule 52 shall provide to that participant, medical management and such compensation in the manner as specified under rule 122DAB of the Drugs and Cosmetics Rules, 1945. (3) Where death of a participant is related to clinical investigation and is attributable to the use of an investigational medical device, the sponsor, permitted under rule 52 shall provide to the legal heir of that participant, such compensation, in such manner as specified under rule 122DAB of the Drugs and Cosmetics Rules, 1945. 56. Powers of search and seizure, etc.— The Medical Devices Officer may enter any premises related to clinical investigation or clinical performance evaluation, with or without an expert, with prior approval of the Central Licensing Authority, with or without prior notice, to inspect the facilities, search and seize, record, data, documents, books, and medical devices including investigational medical devices or new in vitro diagnostic medical device. 57. Maintenance of record.— Every person, sponsor, clinical research organisation, any other organisation or investigator conducting a clinical investigation or his agent holding a permission under this Chapter shall maintain such data, record, registers and other documents for a period of seven years after completion of such investigation and shall furnish such information as may be required by the Central Licensing Authority or any other officer authorised by it in this behalf under rule 56.
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58. Disclosure of name, address, etc., of persons involved in clinical investigation or clinical performance evaluation.— Every person, sponsor, clinical research organisation, any other organisation or investigator conducting a clinical investigation or clinical performance evaluation or any agent authorised by any of them, as the case may be, shall, if so required, disclose to the Medical Device Officer or any other officer authorised by the Central Licensing Authority, the names, addresses and other particulars of persons involved in clinical investigation. 59. Permission to conduct clinical performance evaluation for new in vitro diagnostic medical device.— (1) No person or sponsor shall conduct any clinical performance evaluation in respect of a new in vitro diagnostic medical device on any specimen, including blood or tissue derived from human body except under, and in accordance with, the permission granted by the Central Licensing Authority subject to such conditions and in such form and manner as specified in these rules. (2) An application for grant of permission to conduct, clinical performance evaluation of new in vitro diagnostic medical device shall be made to the Central Licensing Authority in Form MD-24 by the sponsor and shall be accompanied with a fee as specified in the Second Schedule along with information specified in sub-rule (3) duly signed by the sponsor in India: Provided that no fee shall be required to be paid by the institutes, organisation, hospitals, run by the Central Government or the State Government, involved in conduct of clinical performance evaluation of new in vitro diagnostic medical devices. (3) The information required under sub-rule (2) shall contain the following, namely,- (i) approval from an Ethics Committee, which is registered with the Central Licensing Authority, as specified in Appendix VIII of the Schedule Y of the Drugs and Cosmetics Rules, 1945 and referred to in the Seventh Schedule; (ii) source and quantity of samples which shall be used during evaluation; (iii) device description including specification of raw material and finished product, data allowing identification of the device in question, proposed instruction for use, labels and regulatory status in other countries, if any; (iv) in house performance evaluation data used to establish stability, specificity, sensitivity, repeatability and reproducibility; (v) clinical performance evaluation plan stating in particular the purpose, scientific, technical or medical grounds and scope of evaluation; (vi) Case Report Form as specified in Table 6 of the Seventh Schedule; (vii) undertaking by investigators as specified in Table 9 of the Seventh Schedule; (viii) the list of laboratories or other institutions taking part in the evaluation study; (ix) the scheduled duration for evaluation and, in case of devices for self-testing, the location and number of lay persons involved; (x) an undertaking that the device in question conforms to the requirements of these rules, apart from aspects covered by evaluation and apart from those specifically itemised in the undertaking, and that every precaution has been taken to protect the health and safety of the patient, user and other persons. (xi) performance evaluation report from a laboratory designated under sub-rule (1) of rule 19.
(4) The Central Licensing Authority may, in public interest, abbreviate, defer, or waive the requirements of conducting clinical performance evaluation for reasons to be recorded in writing for grant of permission to conduct clinical performance evaluation. (5) If the Central Licensing Authority, after such further enquiry, if any, as may be considered necessary, is satisfied that the requirements of these rules have been complied, may grant permission to conduct clinical performance evaluation for a new in vitro diagnostic medical device in Form MD-25 or may reject the application, for reasons to be recorded in writing, within a period of ninety days from the date of application.
60. Conditions for permission to conduct of clinical performance evaluation.— After grant of permission referred to in sub-rule (5) of rule 59, the following conditions shall be complied with by the applicant, — (i) clinical performance evaluation shall be conducted in accordance with the approved clinical performance evaluation plan and Good Clinical Practices Guidelines; (ii) clinical performance evaluation shall be initiated after approval of clinical investigation plan by the registered Ethics Committee;
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(2) The Central Licensing Authority, after being satisfied with the information furnished along with application under sub-rule (1), may grant permission to import or manufacture medical device which does not have predicate medical device in Form MD-27, or may reject the application for reasons to be recorded in writing, within a period of one hundred and twenty days or such extended period, not exceeding a further period of thirty days, from the date of application: Provided that the Central Licensing Authority shall, where the information is inadequate with regard to the requirements as referred to in sub-rule (1), intimate the applicant in writing within the said period, for reasons to be recorded in writing, the conditions which shall be satisfied before considering the permission: Provided further that if the applicant has not furnished the required information sought by the Central Licensing Authority within ninety days from the date of intimation and the said Authority is satisfied that the information sought was possible to be furnished within the said period, it may reject the application for reasons to be recorded in writing. (3) If the applicant does not receive permission or if the application is rejected within the specified period as referred to in sub-rule (2), the applicant may appeal to the Central Government and that Government may, after such enquiry, as it considers necessary, pass such orders in relation thereto as it thinks fit within a period of sixty days from the date of appeal.
64. Permission to import or manufacture new in vitro diagnostic medical device.— (1) An application for grant of permission to import or manufacture a new in vitro diagnostic medical device may be made to the Central Licensing Authority in Form MD-28 either by an authorised agent in case of import or a manufacturer himself, as the case may be, and shall be accompanied with fee as specified in the Second Schedule along with information specified in Part IV of the Fourth Schedule: Provided that the new in vitro diagnostic medical device used for diagnosis of life threatening, serious diseases or diseases of special relevance to the Indian health scenario, national emergencies, extreme urgency, epidemic and diagnostic medical devices used for diagnosis of conditions, diseases for which there is no diagnostic medical device available in the country, the clinical data requirements may be abbreviated, deferred or omitted, as deemed appropriate by the Central Licensing Authority: Provided further that for new in vitro diagnostic medical device classified under Class A, data on clinical performance evaluation may not be necessary, except in cases, where the Central Licensing Authority, for reasons to be recorded in writing, considers it necessary depending on the nature of the medical device. (2) The Central Licensing Authority, may, after being satisfied with the information furnished along with application under sub-rule (1), grant permission to import or manufacture new in vitro diagnostic medical device in Form MD- or may reject the application, for reasons to be recorded in writing, within a period of ninety days or such extended period, not exceeding a further period of thirty days, from the date of application: Provided that the Central Licensing Authority shall, where the information is inadequate with regard to the requirements as referred to in sub-rule (1), intimate the applicant in writing within the said period, for reasons to be recorded in writing, the conditions which shall be satisfied before considering permission: Provided further that if the applicant has not furnished the required information sought by the Central Licensing Authority within ninety days from the date of intimation and the said Authority is satisfied that the information sought was possible to be furnished within the said period, it may reject the application for reasons to be recorded in writing. 65. Condition of permission to import or manufacture medical device which does not have its predicate device and new in vitro diagnostic medical device.— A Permission under rules 63 in Form MD-27 and rule 64 in Form MD-29 shall be subject to the following conditions, namely: — (a) the medical device shall conform to the specifications submitted along with the application; (b) the permission holder of Form MD-27 shall submit the Periodic Safety Update Report to the Central Licensing Authority from the date of launch in the market and such report shall be submitted every six months for first two years followed by submission of the said report annually for the two more successive years; (c) the permission holder shall inform the date of launch of medical device in the market to the Central Licensing Authority; (d) the permission holder of Form MD-27 shall submit the suspected unexpected serious adverse event within fifteen days of the awareness of the event to the Central Licensing Authority.
CHAPTER IX
DUTIES OF M EDICAL DEVICE O FFICER, MEDICAL DEVICE T ESTING O FFICER AND N OTIFIED BODY
66. Duties of Medical Device Testing Officer.— The Medical Device Testing Officer shall cause the sample of medical device or portion thereof tested or evaluated as may be sent in a sealed package by the Medical Device Officer or any other person under the provisions of Chapters IV, V, VII and XI of these rules, and shall furnish the report of the result of the test or evaluation in accordance with these rules.
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67. Test or evaluation of sample under sub-section (4) of section 25 of the Act.— (1) The sample of medical device for test or evaluation under sub-section (4) of section 25 of the Act shall be sent by registered post in the outer cover addressed to the Director of central medical device testing laboratory in a sealed packet with a memorandum in Form MD-30. (2) The packet as well as the outer cover shall be marked with a distinguishing number. (3) A copy of the memorandum in Form MD-30 and a specimen impression of the seal used to seal the packet shall be separately sent by registered post to the Director of central medical device testing laboratory. (4) After test or evaluation, the result of the test or evaluation shall be sent forthwith to the sender in Form MD-31. 68. Procedure to be adopted by medical device testing officer on receipt of sample.— (1) On receipt of the sealed package of medical device or portion thereof, from a Medical Device Officer or any other person for test or evaluation, the Medical Device Testing Officer shall compare the seals on the packet or on portion thereof with the specimen impression received separately and shall note the condition of the seals on the packet or on portion thereof. (2) After completion of test or evaluation, the Medical Device Testing Officer shall forthwith furnish a report to the Medical Device Officer in triplicate in Form MD-32 of the result of the test or evaluation along with full protocols of the test or evaluation applied. 69. Application for test or evaluation of medical device.— For the purpose of these rules, an application from a purchaser for test or evaluation of a medical device or portion of medical device under section 26 of the Act shall be made in Form MD-33 and the report of such test or evaluation of the medical device which is prepared on such application shall be supplied to the applicant in Form MD-32. 70. Duties of Medical Device Officer.— Subject to the instructions of the Central Licensing Authority or State Licensing Authority, as the case may be, it shall be the duty of Medical Device Officer to, — (i) Inspect, not less than once in a year, all manufacturing sites licenced by the Central Licensing Authority or State Licensing Authority, as the case may be, within the area assigned to him; (ii) conform that the conditions of licence are being observed; (iii) take samples of medical device manufactured or imported for sale, or stocked or exhibited for sale in respect of which the Medical Device Officer has reason to suspect contravention of the provisions of the Act or these rules and send them for test or evaluation: Provided that in case of large sized medical device, wherein the opinion of the Medical Device Officer drawing samples of such a device may not be physically practical, such large sized medical device shall be inspected at the place where these are kept by the Medical Device Officer with or without expert and evaluated or tested by the Medical Device Testing Officer, for any suspect contravention, after approval of the Central Licensing Authority or the State Licensing Authority, as the case may be; (iv) maintain a record of all inspections undertaken, drawing of samples, seizure of stocks and action taken by Medical Device Officer in exercise and performance of duties and to furnish copies of such record to the Central Licensing Authority or the State Licensing Authority, as the case may be; (v) make such enquiries and inspections as may be necessary to detect the manufacture or sale of medical device in contravention of any provision of the Act and these rules; (vi) investigate any complaint made in writing relating to medical device to the Medical Device Officer or any other senior officer in accordance with the direction of the controlling officer; (vii) institute prosecution in relation to contravention of the provisions of the Act and these rules; (viii) review technical dossier of medical device furnished with the application under these rules or any other duties assigned by the Central Licensing Authority or State Licensing Authority, as the case may be, related to these rules. 71. Prohibition of disclosure of information.— Except for the purpose of official business or when required by a Court, a Medical Device Officer or Medical Device Testing Officer shall not, without the previous sanction, in writing, of his official superior, disclose to any person any information acquired while exercising such official duties. 72. Form of order not to dispose of stock.— An order in writing by a Medical Device Officer under clause (c) of sub-section (1) of section 22 of the Act requiring a person not to dispose of any stock in his possession shall be in Form MD-34. 73. Prohibition of sale.— No person in possession of a medical device in respect of which a Medical Device Officer has made an order under clause (c) of sub-section (1) of section 22 of the Act shall, in contravention of that order, sell or otherwise dispose of any stock of such medical device. 74. Form of receipt for seized medical devices, record, register, documents or any other material objects.— A receipt by a Medical Device Officer for the stock of any medical device or for any record, register, document or any other material object seized under clause (c) or clause (cc) of sub-section (1) of section 22 of the Act shall be in Form MD-35.
