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All medical devices in India to
be regulated as “drugs” –
Medical Devices (Amendment)
Rules, 2020
F E B R U A R Y 2 1 , 2 0 2 0 B Y A R O G YA L E G A L
All medical devices in India to be
regulated as “drugs” – Medical
Devices (Amendment) Rules, 2020
Summary:
The Indian law that regulates quality and safety of medical devices has been amended and it will now apply to all medical devices, effective April 1, 2020. Prior to the amendment, only 37 categories of medical devices were regulated or were noti ed to be regulated in near future in India.
The immediate consequence of the amendment in law is as follows:
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Before October 1, 2021, all presently unregulated medical devices will have to be registered by respective importers or manufacturers with the Drugs Controller General of India. However, those medical devices which are already regulated or have been noti ed to to be regulated are exempted from the requirement of registration (see list of 37 categories of medical devices at the end of this article which are exempt from registration). Before August 11, 2022, importers, manufacturers, distributors, whole sellers and retailers of presently unregulated Class A (low-risk) and Class B (low-medium risk) medical devices sold in India will have to compulsorily obtain a license. Before August 11, 2023, importers and manufacturers, distributors, whole sellers and retailers of presently unregulated Class C (medium-high risk) and Class D (high risk) medical devices sold in India will have to compulsorily obtain a license.
In order to obtain registration for medical devices, the importers and manufacturers of the medical devices have to be certi ed as compliant with ISO- 13485 (Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes).
What actually happened?
On February 11, 2020, the Government of India gazetted two noti cations – a new de nition of medical devices and The Medical Devices (Amendment) Rules,
- The cumulative effect of these two noti cations is that all medical devices will be brought under the fold of quality and safety regulation from the effective date of both noti cations – April 1, 2020.
India’s medical device quality regulation
The standards of quality and safety of medical devices are regulated in India by a law called The Drugs and Cosmetics Act, 1940 (“DCA”). The scope of DCA is restricted to only those medical devices which are noti ed by the Government from time to time as “drugs” (commonly referred to as “noti ed medical devices”).
The Medical Devices Rules, 2017 (“MDR”) have been framed under DCA. These rules lay down comprehensive quality requirements to be followed by marketers / importers / manufacturers / sellers of noti ed medical devices.
The way DCA and MDR ensure quality and safety of noti ed medical devices at all levels of the supply chain is by enforcing a mandatory license requirement. All importers / manufacturers / sellers of noti ed medical devices must obtain a license from the appropriate licensing authority before undertaking any commerce in noti ed medical devices. A license is issued only after quality checks. The license holder’s business premise is subject to periodic inspection. A license holder is also required to maintain detailed records of the sale-purchase undertaken in relation to noti ed medical devices and ensure traceability in the event of a quality or safety-related failure or complaint.
New De nition of Medical Devices
Until February 11, 2020, the Government had regulated or noti ed 37 categories of medical devices as drugs (see list of these 37 categories of medical devices at the end of the article). On February 11, 2020, the government exercised its powers to notify one or more categories of medical devices as “drug” to actually notify a new de nition of medical devices.
As per the noti cation, effective April 1, 2020, the medical devices that fall under the following de nition will be regulated as “drug” under the DCA and MDR:
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Sterile or Non-sterile status, Brand name only if registered under India’s trade mark law)
- Certi cate of compliance with respect to ISO 13485 standard accredited by National Accreditation Board for Certi cation Bodies or International Accreditation Forum in respect of such medical device
- Free sale certi cate from country of origin (for imported devices only)
- A duly signed undertaking stating that the information furnished by the applicant is true and authentic
The registration will be complete only upon generation of a registration number.
If an importer or manufacturer is unable to obtain registration for its Newly Noti ed Medical Device before October 1, 2021, then it will not be able to market and sell its medical device in India until a registration is obtained.
The importer or manufacturer of a medical device which belongs to one of the 37 categories of medical device regulated or noti ed prior to February 11, 2020 (see list at the end of this article) are exempt from the requirement to obtain registration for its medical device and therefore can continue to carry on their business on the strength of the license issued by appropriate licensing authority.
Label declaration of registration number
Every importer and importer who obtains a registration number for its medical device will have to display the registration number on its label. The requirement to declare registration number is not tied to the deadline for registration (October 1, 2021). Rather it is an immediate requirement and will trigger from the time the registration number is issued, unless otherwise mandated by DCGI.
Consequence of obtaining registration
A certi cate of compliance with ISO-13485 (Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes) is mandatory for registration of Newly Noti ed Medical Device. Therefore, an importer or manufacturer of a registered medical device will have to ensure that the requirements of ISO 13485 are met at all times. Broadly speaking, ISO 13485 requires creation, documentation and implementation of a quality management system which is to be supplemented by an independent audit from time to time.
Once an importer or manufacturer registers its medical devices, it will have to strictly conform to its documented quality management system.
If any gap is found in the implementation of quality management system by DCGI, it will have the right to suspend or cancel the registration of the medical device. An order of suspension or cancellation of registration for medical device will prevent the importer or manufacturer of said medical device to further import or manufacture said medical device.
Consequences of registration on supply chain
There is no consequence of registration of medical device on its supply chain. The supply chain will not be required to obtain registration or license to sell registered medical devices.
Requirement to obtain a license
In addition to registration, importers and manufacturers of Newly Noti ed Medical Devices will have to obtain a license under MDR before the prescribed deadline (see table for deadlines).
In the table below, we have listed the name of the authority who will issue the license to importers and manufacturers along with prescribed deadlines.
Class of medical device
Licensing Authority
Stipulated timeline for processing application
Deadline for obtaining license (^) Privacy - Terms
Class A and B (import)
DCGI Up to 9 months from the date of application
August 11, 2022
Class C and D (import)
DCGI
Up to 9 months from the date of application
August 11, 2023
Class A (manufacture)
State-level Licensing Authority
Up to 45 days from the date of application August 11, 2022
Class B (manufacture)
State-level Licensing Authority
Up to 140 days from the date of application August 11, 2022
Class C and D (manufacture)
DCGI
120 – 180 days (estimated)
August 11, 2023
It is important to note that it is not mandatory to have a registration number in order to obtain a license. Therefore, the application for license can be made anytime after April 1, 2020 (or such other date that DCGI may specify in future).
If a license is obtained much in advance before the deadline gets over, it will not obligate the manufacturer or importer to comply with the requirements of MDR only on the grounds that a license has been obtained. For example, if a Class C or Class D medical device importer or manufacturer obtains a license before the deadline of August 11, 2023, the said importer or manufacturer will not have to declare the import license number on the label. The supply chain of the said device also will not require a license just because the medical device importer or manufacturer has applied for and received a license. However, after the deadline gets over, all the compliances stipulated under MDR including the requirement to obtain license by the entire supply chain will have to be met. The routine inspections of warehouses or manufacturing premises should also begin only after the prescribed deadline gets over.
The risk-classi cation of all medical devices (Class A, B, C, D) will be done by the DCGI. It is expected that the DCGI will come out with a list of classi cation of medical devices on or before April 1, 2020. However, in the meanwhile, anybody interested in knowing the potential classi cation of medical device can refer either refer to parameters of classi cation of medical devices described in the rst schedule to MDR or to its classi cation in a GHTF country (EU, Australia, Canada, Japan, USA etc .) because India largely follows GHTF principles of classi cation of medical devices.
Therefore, it may not hurt importers and manufactures of Newly Noti ed Medical Devices to make an application to obtain a license suf ciently in advance of the expiry of deadline.
Supply chain to obtain license
The supply chain of Newly Noti ed Medical Devices (including marketers) will also have to obtain appropriate license for distribution (i.e.Wholesale ) or retail sale before the deadline for obtaining a license for respective class of devices expires. See table below for the name of the authority who will issue the license and for prescribed deadlines.
Class of medical device
Licensing Authority
Stipulated timeline for processing application
Deadline for obtaining license
Class A and B (imported or manufactured)
State-level Licensing Authority
Up to 3 months (estimated)
August 11, 2022
Class C and D (imported or manufactured)
State-level Licensing Authority
Up to 3 months (estimated)
August 11, 2023 Privacy - Terms
and obtain registration for hitherto unregulated medical devices. Now, the onus is on the industry to do its part and reinforce the belief of the Indian consumer and the international community in the quality and safety of medical devices sold in India.
List of 37 categories of medical devices regulated or proposed to be regulated but noti ed before February 11, 2020, and therefore not affected by the amendment
- Disposable Hypodermic Syringes;
- Disposable Hypodermic Needles;
- Disposable Perfusion Sets;
- Substances used for in vitro diagnosis including Blood Grouping Sera;
- Cardiac Stents;
- Drug Eluting Stents;
- Catheters;
- Intra Ocular Lenses;
- I.V. Cannulae; 10. Bone Cements; 11. Heart Valves; 12. Scalp Vein Set;
- Orthopedic Implants;
- Internal Prosthetic Replacements;
- Ablation Devices;
- Ligatures, Sutures and Staplers;
- Intra Uterine Devices (Cu-T)
- Condoms; 19. Tubal Rings; 20. Surgical Dressings;
- Umbilical tapes;
Blood/Blood Component Bags;
- Organ Preservative Solution;
- Nebulizer (effective from 1 Jan.2021);
- Blood Pressure Monitoring Device (effective from 1 Jan.2021);
Glucometer (effective from 1 Jan.2021);
- Digital Thermometer (effective from 1 Jan.2021);
- All implantable medical devices Equipment (effective from 1, April,2021);
- CT Scan Equipment (effective from 1, April,2021);
30. MRI
Equipment (effective from 1, April,2021);
- De brillators (effective from 1, April,2021);
32. PET
Equipment(effective from 1, April,2021);
- X-Ray Machine (effective from 1, April,2021);
- Dialysis Machine (effective from 1, April,2021);
- Bone marrow cell separator (effective from 1, April,2021);
- Disinfectants and insecticide speci ed in Medical Devices Rules, 2017;
- Ultrasound equipment (effective from 1, November, 2020)
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