Tag: Drugs

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 notified to be regulated in near future in India.

The immediate consequence of the amendment in law is as follows:

• 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 notified 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 October 1, 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 October 1, 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 certified 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 notifications – a new definition of medical devices and The Medical Devices (Amendment) Rules, 2020. The cumulative effect of these two notifications is that all medical devices will be brought under the fold of quality and safety regulation from the effective date of both notifications – 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 notified by the Government from time to time as “drugs” (commonly referred to as “notified 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 notified medical devices.

The way DCA and MDR ensure quality and safety of notified medical devices at all levels of the supply chain is by enforcing a mandatory license requirement. All importers / manufacturers / sellers of notified medical devices must obtain a license from the appropriate licensing authority before undertaking any commerce in notified 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 notified medical devices and ensure traceability in the event of a quality or safety-related failure or complaint.

New Definition of Medical Devices

Until February 11, 2020, the Government had regulated or notified 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 definition of medical devices.

As per the notification, effective April 1, 2020, the medical devices that fall under the following definition will be regulated as “drug” under the DCA and MDR:

All devices including an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings or animals which does not achieve the primary intended action in or on human body or animals by any pharmacological or immunological or metabolic means, but which may assist in its intended function by such means for one or more of the specific purposes of ― (i) diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder; (ii) diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability; (iii) investigation, replacement or modification or support of the anatomy or of a physiological process; (iv) supporting or sustaining life; (v) disinfection of medical devices; and (vi) control of conception.

The above new definition is intended to cover all medical devices, as per technical discussions that preceded the notification of the above definition. Thus, by virtue of this definition, all medical devices sold in India will come to be regulated by DCA and MDR from April 1, 2020, when the definition takes effect.

For the purpose of this article, all medical devices which were not notified until February 11, 2020 (i.e. other than the list of 37 categories of medical devices listed at the end of this article), and will now be covered by the new definition of medical devices will be referred to as “Newly Notified Medical Devices”.

The Medical Device (Amendment) Rules, 2020

On February 11, 2020, the government also notified The Medical Device (Amendment) Rules, 2020 (“MDR Amendment”). The MDR Amendment introduces two changes to MDR. The first is introduction of a new chapter for registration of Newly Notified Medical Devices by their respective manufacturers and importers. The second is an exemption for the 37 categories of already regulated or notified medical devices from the requirement of registration introduced by the new chapter.

Requirement of registration

The manufacturers or importers of Newly Notified Medical Devices will be required to compulsorily register their medical devices with the Drugs Controller General of India (“DCGI”) before October 1, 2021. The DCGI will start accepting applications for registration through a dedicated online portal called “Online System for Medical Devices” from April 1, 2020 (or from such later date by when the online portal to ready to accept applications). There is no time-frame prescribed as of now for processing of the application for registration by DCGI. It appears that the registration will be done instantly after submission of all information and documents on the online portal i.e. without any examination of the information and documents submitted by the applicant at the hands of DCGI.

The registration process is relatively simpler and should not be equated to a full-fledged marketing registration or authorization. Any importer or manufacturer of Newly Notified Medical Device will be able to obtain registration on the submission of the following information:

1. Name of the company or firm or any other entity
2. Name and address of manufacturing site (for devices manufactured in India only)
3. Specification and standards of medical device (for imported devices only)
4. Details of medical devices (Generic Name, Model No., Intended Use, Class of Medical Device, Material of Construction, Dimensions (if applicable), Shelf Life, Sterile or Non-sterile status, Brand name only if registered under India’s trade mark law)
5. Certificate of compliance with respect to ISO 13485 standard accredited by National Accreditation Board for Certification Bodies or International Accreditation Forum in respect of such medical device
6. Free sale certificate from country of origin (for imported devices only)
7. 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 Notified 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 notified 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 certificate of compliance with ISO-13485 (Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes) is mandatory for registration of Newly Notified 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 Notified 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
Class A and B (import)	DCGI	Up to 9 months from the date of application	September 30, 2022
Class C and D (import)	DCGI	Up to 9 months from the date of application	September 30, 2023
Class A (manufacture)	State-level Licensing Authority	Up to 45 days from the date of application	September 30, 2022
Class B (manufacture)	State-level Licensing Authority	Up to 140 days from the date of application	September 30, 2022
Class C and D (manufacture)	DCGI	120 – 180 days (estimated)	September 30, 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 September 30, 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-classification 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 classification of medical devices on or before April 1, 2020. However, in the meanwhile, anybody interested in knowing the potential classification of medical device can refer either refer to parameters of classification of medical devices described in the first schedule to MDR or to its classification in a GHTF country (EU, Australia, Canada, Japan, USA etc.) because India largely follows GHTF principles of classification of medical devices.

Therefore, it may not hurt importers and manufactures of Newly Notified Medical Devices to make an application to obtain a license sufficiently in advance of the expiry of deadline.

Supply chain to obtain license

The supply chain of Newly Notified 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)	September 30, 2022
Class C and D (imported or manufactured)	State-level Licensing Authority	Up to 3 months (estimated)	September 30, 2023

Relaxation to obtain registration and license

The government has given time to the medical device industry to transition into the regulatory framework and to obtain ISO 13485 certification, if not already obtained.

The government has relaxed the requirement to obtain registration and license for Newly Notified Medical Devices for the following period:

• April 1, 2020 to September 30, 2021 – No registration or license will be required to manufacture, import, distribute or sell Newly Notified Medical Devices;
• October 1, 2021 to September 30, 2022 – Registration will be required to import or manufacture such medical devices, but no license will be required;
• October 1, 2022 to September 30, 2023 –  License will be required to manufacture, import, distribute or sell Class A or Class B medical devices, but no license will be required to manufacture, import, distribute or sell Class C or Class D medical devices; and
• After October 1, 2023 – License will be required to manufacture, import, distribute or sell Class C and Class D medical devices as well.

Exemption for devices regulated or proposed to be regulated but notified before February 11, 2020

As indicated earlier, the 37 categories of medical devices regulated or notified before the date of MDR Amendment i.e. February 11, 2020, will not be affected by the MDR Amendment and therefore will not be required to obtain registration. The list of 37 categories of medical devices is reproduced at the end of this article.

However, being exempted from application of the MDR Amendment does not mean that they are exempted from MDR itself. These devices and their importers, manufactures and the entire supply chain will have to obtain a license and observe other compliances stipulated under MDR at all times.

Consequences of non-registration or of not obtaining license before deadline

If an importer or manufacturer of a Newly Notified Medical Device fails to obtain a registration until October 1, 2021, then it will have to cease import or manufacture of said medical device until such time the registration is obtained. It will be easy for the DCGI or State-level Licensing Authority to know whether a medical device is manufactured or imported without registration. Under the Legal Metrology (Packaged Commodity) Rules, 2011, every importer and manufacturer of any medical device (whether regulated or unregulated) is required to declare the date of import of medical device or date of manufacture of medical device on its label. Therefore, if a declaration exists on the label of a medical device that the medical device has been imported  or manufactured on or after October 1, 2021, but the label does not show a DCGI registration number, then it will be confiscated by DCGI or appropriate State-level Licensing Authorities and action will be taken against the importer or manufacturer.

Any violation of MDR including failure to obtain registration or license before stipulated deadline may result in criminal prosecution resulting in imprisonment and fine. Any stock of medical device that is sold without registration or license could also be confiscated.

Final comments

The expansion of definition of medical device and the requirement to obtain registration for medical devices should not come as a surprise because the Government had published a draft of these notifications in October last year. It was covered extensively at the time, including by us.

In our view, the notification of the new (and comprehensive) definition of medical device has brought finality to the issue of regulation of all medical devices that has haunted the government and Indian consumers for a long time. The Government has now given sufficient time for the industry to adopt ISO 13485 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 notified before February 11, 2020, and therefore not affected by the amendment

1. Disposable Hypodermic Syringes;	2. Disposable Hypodermic Needles;	3. Disposable Perfusion Sets;	4. Substances used for in vitro diagnosis including Blood Grouping Sera;
5. Cardiac Stents;	6. Drug Eluting Stents;	7. Catheters;	8. Intra Ocular Lenses;
9. I.V. Cannulae;	10. Bone Cements;	11. Heart Valves;	12. Scalp Vein Set;
13. Orthopedic Implants;	14. Internal Prosthetic Replacements;	15. Ablation Devices;	16. Ligatures, Sutures and Staplers;
17. Intra Uterine Devices (Cu-T)	18. Condoms;	19. Tubal Rings;	20. Surgical Dressings;
21. Umbilical tapes;	22. Blood/Blood Component Bags;	23. Organ Preservative Solution;	24. Nebulizer (effective from 1 Jan.2021);
25. Blood Pressure Monitoring Device (effective from 1 Jan.2021);	26. Glucometer (effective from 1 Jan.2021);	27. Digital Thermometer (effective from 1 Jan.2021);	28. All implantable medical devices Equipment (effective from 1, April,2021);
29. CT Scan Equipment (effective from 1, April,2021);	30. MRI Equipment (effective from 1, April,2021);	31. Defibrillators (effective from 1, April,2021);	32. PET Equipment(effective from 1, April,2021);
33. X-Ray Machine (effective from 1, April,2021);	34. Dialysis Machine (effective from 1, April,2021);	35. Bone marrow cell separator (effective from 1, April,2021);	36. Disinfectants and insecticide specified in Medical Devices Rules, 2017;
37. Ultrasound equipment (effective from 1, November, 2020)