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Frequently Asked Questions on new registration requirement for medical devices in India

FAQs on Registration of Medical Devices

All medical devices that are manufactured in India or are imported into India have to either be licensed or registered by October 1, 2021. If a medical device is manufactured or imported after October 1, 2021 without registration or license, it will be deemed to have been manufactured or imported in violation of Indian law, thereby inviting penal action.

As a background, until 2020, the Indian Government regulated 37 categories of medical devices (scroll down for list) under the Drugs and Cosmetics Act, 1940 (DCA) and Medical Devices Rules, 2017 (MDR) for safety, quality and effectiveness. A license is presently required to manufacture or import these 37 categories of medical devices.

In 2020, the Indian Government brought about a change in law to the effect that manufacturers and importers of all medical devices other than the 37 categories of medical devices have to obtain registration ‘voluntarily’ before October 1, 2021. Those manufacturers and importers who are unable to obtain registration before October 1, 2021 would have to either stop business of said medical devices till they obtain the requisite registration, or risk facing penal consequences of violating DCA and MDR.

With an intent to help and support medical devices companies who wish to obtain a registration, we have put together a list of frequently asked questions (FAQs) with our responses in this article.

Please note that these FAQs are based on our understanding of the law, and under no circumstances should they be regarded as legal or professional advice or an endorsement of any industry practice.

What is this new requirement for obtaining registration for medical devices and equipment?

Owing to an amendment to Medical Devices Rules, 2017 in February of 2020 (said amendment hereinafter referred to as “Medica Devices (Amendment) Rules, 2020” or “MDR 2020”), manufacturers and importers of all medical devices and equipment (with the exception of those that have been notified by the government) in India are required to register their medical devices in India before October 1, 2021.

The list of devices notified by the government, to which the requirement of registration does not apply, is reproduced at the end of these FAQs.

Is the registration requirement voluntary or mandatory?

As per MDR 2020, the enforcement of registration requirementis to begin from October 1, 2021. The government has given time to the medical device industry to register ‘voluntarily’ by October 1, 2021. After that, manufacturers and importers will have to ‘mandatorily’ register their medical devices and equipment in order to be able to manufacture in India or import medical devices into India.

How to obtain registration?

In order to obtain registration, the manufacturer or importer of a medical device or equipment has to register itself, its medical device or equipment as well as the manufacturing site with the Central Drugs Standards Control Organization (CDSCO).

The registration is successful once the file number is generated.

What is the objective behind registration requirement?

The Indian government’s objective behind imposing registration requirement appears to be phase-wise regulation of all medical devices.

The pre-requisite for obtaining registration is just the existence of a ISO 13485 certificate (quality management system for medical devices) issued by a certification body accredited with National Accreditation Board for Certification Bodies (NABCB) or International Accreditation Forum (IAF) to the manufacturer of medical devices. No safety or effectiveness data is required to be submitted for obtaining registration. The intent of the Indian Government appears to be to ensure that by October 1, 2021, all medical devices sold in India must be manufactured at a facility whose quality management systems meet the standards specified in the ISO 13485, as certified by an accredited certifying body.

Is there a list of medical devices available to which the registration requirement is applicable?

 CDSCO has published a draft list of medical devices that may require registration. However, since this is only a draft list, there may be medical devices which are not part of the list but would still be subject to registration requirement.

 In order to evaluate whether a product qualifies as medical device or not (and consequently would be subject to registration requirement or not), one may refer to the following definition of medical devices under 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

If a device or equipment is covered by the definition of above, and it is not part of the list of devices specifically notified by the government (see bottom of the article for list), then such a device or equipment will be subject to registration requirement in India.

In certain cases, it may be helpful to avail expert advice in evaluating whether a product or equipment qualifies as a medical device under Indian law and is covered by registration requirement or not.

Whether components and accessories of medical devices are required to be registered?

Component and accessories of medical devices would be subject to registration requirement only if they qualify as medical device as per the definition of medical device i.e. if they are intended by their manufacturer to be used for medical purposes.

As per a recent clarification issued by CDSCO, components and accessories of medical devices imported as a system need not be registered separately. However, it is unclear what ‘separately’ implies, and why such an exemption should be given only to imported systems. It is our view that all components and accessories should be registered as part of the system because the official form for registration has fields under which details of components and accessories may be provided. In case components and accessories are not registered as part of the system for some reason, they should be registered separately, as components and accessories are ‘medical devices’ in their own right as per the definition of medical device.

In other words, components and accessories of medical devices may be registered alongside the system or independently, as long as they qualify as ‘medical device’ as per the definition of medical device.

What are the consequences of not obtaining registration before October 1, 2021?

A device to which registration requirement applies cannot be legally manufactured or imported into India without registration after October 1, 2021. The manufacturers and importers of such medical devices would have to obtain a registration for such devices in India before they can market these devices.

If a device is manufactured or imported after October 1, 2021 into India for marketing purposes without registration, then it would invite penal action under The Drugs and Cosmetics Act, 1940.

Who can make the application for registration?

An importer or manufacturer of the medical device or equipment can make the application for registration.

Can an importer obtain registration for imported medical device or equipment without whole sale drug license?

In order to create an account on the CDSCO’s registration portal as an importer, it is a pre-requisite to possess a whole sale drug license. However, for the time being, CDSCO is allowing registrations without a whole sale drug license as well.

What is the government fee payable for registration?

There is no government fee payable for registration.

What information is required to be provided for obtaining registration?

The following information has to be provided for obtaining registration:

  • Legal manufacturer’s name & address with Phone no., Fax & Email id, 
  • Actual Site Details (Name, Address, Email ID, Fax No. & Contact No.)
  • Nature of activity (import/export)
  • Category of Device (medical device / IVD)
  • Generic Name, Model No.,
  • Intended Use,
  • Product Description,
  • Class of Medical Device
  • Medical Device Category
  • Grouping Category
  • Material of Construction,
  • Dimension (If any)
  • Shelf Life
  • Storage Condition,
  • Package Size,
  • Sterile or Non-Sterile,
  • Brand Name (If registered under the Trade Marks Act, 1999)

What are the documents required to be submitted obtain registration?

In addition to the information, the following documents are required to be submitted for registering a medical device: (1) an ISO 13485 certificate; (2) a Certificate to Foreign Government or Free Sale Certificate (for imported medical devices); and (3) an undertaking stating that the information and documents supplied are true and authentic are required to be submitted.

What is ISO 13485?

ISO 13485 is a standard for quality management system for designing and manufacturing a medical device.

Who issues ISO 13485 certificate?

ISO 13485 certificate is issued by a certifying body. For the purposes of registration, the ISO 13485 certificate must be issued by a certifying body accredited by National Accreditation Board for Certification Bodies in India or the International Accreditation Forum.

What is Free Sale Certificate or Certificate to Foreign Government?

A Free Sale Certificate or Certificate to Foreign Government is issued by a Regulatory Authority / Ministry of the country in which the medical device is approved and marketed. It serves as proof that the medical devices manufactured in the country as freely sold in that country (or region).

Is there a prescribed format for the undertaking to be submitted along with the application?

There is no prescribed format for the undertaking.

What are the compliances to be done after obtaining registration?

The registration number (file number) has to be declared on the label of the medical device.

How long does it take for the registration to be received once the application has been submitted?

After the application for registration is submitted, a file number is generated instantaneously. The generation of the file number concludes the process of registration.

What is the registration number?

The file registration number is the registration number.

Is the registration number different for different medical devices and equipment?

The registration number differs as per the manufacturing site. Different medical device and equipment manufactured at the same site will receive the same registration number. Same medical devices manufactured at different manufacturing sites will receive different registration numbers.

What happens if the applicant submits incorrect information?

Once incorrect information has been submitted, it can only be rectified by CDSCO. The CDSCO requires applicants to submit an undertaking at the time of submission of the application for registration that information contained in the application is true and accurate. Therefore, it is paramount that the information submitted as part of the registration application is true and accurate.

What is the penalty for submitting false information or documents?

The CDSCO may cancel full or part of the registration, effectively making it impossible to sell medical devices in question in India.

Is it possible to sell medical devices and equipment manufactured in India or imported into India before October 1, 2021 without registration?

Given past precedents in similar matters, it is likely that medical devices imported or manufactured before October 1, 2021 may be permitted to be sold in India without registration. However, no medical device imported or manufactured in India after October 1, 2021 may be sold in India if it is not registered and labelled with the registration number.

It will be easy for enforcement authorities to check whether a medical device or equipment has been manufactured or imported into India on or after October 1, 2021 because the Legal Metrology (Packaged Commodities) Regulations, 2011 require the all packaged commodities to contain either date of manufacture or date of import.

Is it possible to sell unregistered medical devices in India which have been manufactured or imported after October 1, 2021?

No. It will be violation of DCA and MDR if a manufacturer, importer or trader sells an unregistered medical device which is manufactured or imported into India on or after October 1, 2021.

In other words, the concerned manufacturer or importer will have to register its medical devices in order to manufacture or import medical devices after October 1, 2021 for sale in India. In such cases, the registration will no longer be “voluntary” but mandatory. The registration number will have to displayed on the label of such medical devices.

Will the process for obtaining registration change after October 1, 2021 when obtaining registration for medical devices and equipment is no longer voluntary?

It is our understanding that it will not change.

For how long is the registration valid?

The registration is valid until appropriate manufacturing or import license is obtained by the concerned manufacturer or importer for those devices.

Before August 11, 2022, importers, manufacturers, distributors, whole sellers and retailers of Class A (low-risk) and Class B (low-medium risk) medical devices will have to compulsorily obtain a license. Before August 11, 2023, importers and manufacturers, distributors, whole sellers and retailers of Class C (medium-high risk) and Class D (high risk) medical devices will have to compulsorily obtain a license. The CDSCO is in the process of undertaking risk classification of all medical devices.

List of medical devices that are not covered by registration requirement

 The requirement to obtain registration does not apply to below categories of medical devices as these categories of medical devices are already regulated and require a license for manufacture, import, sale and distribution in India. In other words, if a manufacturer or importer has a license for manufacture or import of medical device, then registration requirement will not apply to such manufacturer or importer.

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
25. Blood Pressure Monitoring Device26. Glucometer27. Digital Thermometer28. All implantable medical devices Equipment
29. CT Scan Equipment30. MRI Equipment31. Defibrillators32. PET Equipment
33. X-Ray Machine34. Dialysis Machine35. Bone marrow cell separator36. Disinfectants and insecticide specified in Medical Devices Rules, 2017;
37. Ultrasound equipment (effective November 1, 2021)   
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Draft risk classification of all yet-to-be regulated medical devices and IVDs in India published, comments invited until Oct. 2

In February of this year, India’s Health Ministry had notified a new definition of medical devices with an intent to bring all medical devices under the purview of Medical Devices Rules, 2017 (MDR). Prior to such notification, only 37 categories of medical devices that it had notified were regulated by MDR. The new definition took effect from April 1, 2020, which means that MDR started applying to all medical devices from April 1, 2020. However, an exemption from applicability of MDR was added until August 11, 2022 for Class A (low risk) and Class B (low-medium risk) medical devices, and until August 11, 2023 for Class C (medium-high risk) and Class D (high risk) medical devices, in order give time to industry to acclimatize itself to the new regulatory framework of MDR and to obtain appropriate medical device quality certification such as ISO 13485 from designated certifying bodies.

After the development in February, since MDR regulates medical devices on the basis of their risk classification, there was always a question as to how will these yet-to-be regulated or (more appropriately) newly regulated medical devices will be classified. Unlike most countries, risk classification of medical devices is determined in India by the regulator, Drugs Controller General of India (DCGI), itself as per parameters of risk classification stipulated in First Schedule of MDR, and there is no room for dialogue or consultation with the regulator once the risk classification has been concluded.

The DCGI has now done its preliminary assessment and published a draft of medical device risk classification covering all medical devices for public comments. Medical devices have been split into 24 categories (Anethesiology, Pain Management, Cardiovascular, Dental, ENT, Gastroenterlogical, Urological, General Hospital, Operation Theatre, Respiratory, Neurological, Personnel Use, Obstetrical and Gynecological, Ophthalmic, Rehabilitation, Physical support, Interventional and Radiology, Rheumatology, Dermatology, Plastic Surgery, Pediatric and Neonatology Medical, Oncology, Radiotherapy, Nephrology and Renal care and Software). IVD devices have been split into 3 categories (IVD Analyzer, IVD Instrument and IVD Software).

There are some surprises in the risk classification. Sanitary pads, menstrual cups and tampons are sought to be regulated as medical devices. Fertility and conception software are sought to be regulated as medical devices. Birthing bath and new-born infant bed are also sought to be regulated as medical devices.

It is extremely important that the impacted companies review the draft risk classification and provide comments to DCGI before October 2, 2020 regarding either the inapplicability of law i.e. MDR to their products, or the inappropriateness of risk classification assigned by DCGI. Once the risk classification is finalized, it may not be revised for some time. Also, once MDR starts applying to a medical device, other laws such as Drugs (Prices Control) Order, 2013 will also start applying to such medical device.

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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 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)      
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All medical devices to be regulated: Draft rules notified in India

The Ministry of Health and Family Welfare in India has notified the Draft Medical Devices (… Amendment) Rules, 2019 (Draft Rules) for public comments on October 18, 2019. By notifying these rules, the Indian Government has made its intention clear to regulate all medical devices in a phased manner. As of date, only twenty-three categories of medical devices are regulated by the Indian Government. Thirteen categories of medical devices will be regulated from the year 2020.

Highlights

Amendment to Medical Devices Rules, 2017: The Draft Rules will be incorporated within the existing Medical Devices Rules, 2017 (MDR). This is an important fact considering some news reports had indicated that the Union Government was planning to completely overhaul the medical device regulatory framework which would have affected the medical devices that are currently regulated, as well. Thus, medical devices which are presently regulated should not be impacted upon formalization of the Draft Rules.

New registration requirement: All medical device manufacturers and importers will have to register themselves and their medical devices with the Central Licensing Authority (i.e. the Drugs Controller General of India).

Key requirements for registration in case of manufacturers: In order to register, a manufacturer will have to submit a) name and address of the manufacturer and the manufacturing site, b) details of medical devices, including shelf life and c) certificate of compliance with ISO 13485.

Key requirements for registration in case of importers: In order to register, an importer will have to submit a) name and address of the importer, b) specification and standards of the medical device, c) details of medical devices, including shelf life, c) certificate of compliance with ISO 13485 and e) free sale certificate from country of origin.

Grace period for registration:  It will be voluntary for manufacturers and importers to register themselves until the expiry of eighteen months from the date of notification of the final rules (“Grace Period”).

Registration to be mandatory: After expiry of Grace Period, it will be unlawful for manufacturers and importers to market the medical device in India without a registration issued by the Central Licensing Authority.

License requirement: Manufacturers and importers of Class A (low risk) and Class B (low medium risk) medical devices will have to obtain a license under MDR from the appropriate authority within 12 months of the expiry of the Grace Period. Manufacturers and importers of Class C (medium-high risk) and Class D (high risk) medical devices will have to obtain a license under MDR from the appropriate authority within 24 months of the expiry of the Grace Period.

Labelling requirement: Once registered, both manufacturers and importers will have to mention their registration number on the label of the medical device.

Dedicated portal for registration: There will be a dedicated portal called ‘Online System for Medical Devices’ that will be set-up for registration of medical devices.

Open for comments: The Draft Rules are open for comments for thirty days from the date of notification, i.e. until November 17, 2019.

Background

India is one of the few countries which currently does not regulate all medical devices, including some of the ones that are put on or inside the human body. The objective of the Draft Rules is to bring all medical devices within the purview of the regulatory framework. The ultimate objective, of course, is to set a scientific benchmark for safety, quality and performance of all medical devices and ensure that every medical device sold in India conforms to this benchmark. On a separate note, it was important for the Indian Government to take strong steps to ensure safety and quality of all medical devices manufactured in India to give a boost to its flagship Make in India programme, especially since the reduction of import dependence on medical devices is high up on the Government’s agenda.

Issues

The current language of the Draft Rules is not without shortcomings. Some of the key shortcomings that we have identified are:

The lack of clear definition of medical device: The Draft Rules will be effective only when the Ministry of Health and Family Welfare notifies that all medical devices will be regulated as drugs under Section 3(b)(iv) of The Drugs and Cosmetics Act, 1940. Currently, only thirty-six categories of medical devices have been notified as drugs, as discussed in the introductory part of this article. It is expected that such a notification will soon follow the notification of the Draft Rules once they are finalized. However, the current definition of medical devices under MDR is a very limited definition. It does not lay down a uniform set of criteria to determine when any substance or article can be called a medical device for the purposes of MDR. It is expected that the Ministry of Health and Family welfare will notify another amendment to MDR and amend the definition of medical devices to lay down certain objective criteria for classification as a medical device. Without a uniform set of criteria, it will be very difficult for manufacturers and importers to assess whether their product falls under the category of medical device or not.

Discretion to choose class of medical devices for registration: In most countries around the world, it is up to the manufacturer or importer of medical devices to select a risk categorization for its medical device and justify it to the national regulatory agency. However, in India, as per Rule 4(3) of MDR, the Central Licensing Authority itself determines the risk classification of the medical devices. There is no formal avenue to justify or review the risk classification of medical devices once it is determined by the Central Licensing Authority. Interestingly, for the purpose of registration, the Central Licensing Authority has allowed importers and manufacturers to declare a risk classification as they deem fit. The current text of the Rules does not empower the Central Licensing Authority to review the risk classification before the grant of registration. This may result in a situation where two manufacturers of the same generic medical device may declare different risk classifications. The proper determination of risk classification is especially relevant since it may have an impact on quality management system adopted by the manufacturers (and importers, as the case may be).

Time-frame to adopt ISO 13485: The ISO 13485 is essentially a quality management system for medical devices. In order to obtain a certificate of compliance with ISO 13485, a manufacturer/importer has to not just show that the required documentation and processes that assure quality are in place, but also demonstrate that the quality management system is functional. There are many manufacturers / importers / marketers in India who have a portfolio of numerous medical devices. It could be an onerous task for them to put in place a functional quality management system for all medical devices in their portfolio and obtain a registration from the Central Licensing Authority within 18 months (i.e. within the Grace Period). As per some industry estimates, it may easily take up to a year or more for mid-size businesses to put in place a functional quality management system that complies with the requirements of ISO 13485.

Adverse consequences of ‘voluntary’ registration: If a manufacturer or importer already has a certificate of compliance with ISO 13485, it does not make commercial sense for it to obtain registration from Central Licensing Authority until shortly before expiry of the Grace Period (i.e. eighteen months from the date of notification). This is because immediately upon receipt of registration, it will have to start declaring the registration number on the label. Typically, any change to packaging, including to the label, requires months of advanced planning from a product continuity perspective. Further, once registered, the manufacturer or importer would be liable to be investigated by the Central Licensing Authority for quality and safety. This rationale is also applicable to manufacturers and importers of medical devices who do not have certificate of compliance with ISO 13485 yet, but can obtain it in short time. Instead, it would have been pragmatic for Central Licensing Authority to take some time and set-up a system for registration that is exhaustive and fool-proof, so that it could gather greater quantity and quality of information from registrations.

Potential supply chain disruption: Though the Draft Rules put in place a registration requirement, please note that a license requirement will also be applicable for such medical devices in due course, as highlighted earlier. It is quite likely that the supply chain (i.e. super stockists, distributors, third-party logistics providers) of most of the currently unregulated medical devices does not have a license to sell a medical device. When the license requirement becomes applicable for medical device manufacturers and importers, it will also become applicable for the entire supply chain (i.e. they will have to obtain a license to sell a medical device by wholesale or retail from appropriate licensing authority). If the entire supply chain does not obtain a license by then, it could result in supply chain disruption.

Price control: Once medical devices come within the regulatory framework of MDR, they will automatically come within the price control framework of Drugs (Prices Control) Order, 2013 (DPCO). In fact, unregulated medical devices will come within the price control framework from the date of notification of the final rules. This is because DPCO applies to all drugs, and the definition of drugs is the same as that under Drugs and Cosmetics Act, 1940 (DCA). Since MDR has been framed under DCA by creating a deeming fiction that medical devices are drugs, the currently unregulated devices will also come under the ambit of DPCO. The immediate consequence of application of DPCO would be that the marketers of the medical device will not be able to increase its MRP by more than 10% in any continuous 12 month period. Under certain circumstances, their prices may also be fixed by the Government.

Comment

The regulation of all medical devices is a welcome change that is expected to level the playing field. More importantly, it is expected to give assurance of quality and safety to the common man who gets exposed to one or the other medical device at some stage of his/her life. It is hoped that the Central Drugs Standards Control Organization would consider some of the issues highlighted herein and address them before notifying the final rules. In the meanwhile, the medical device industry should prepare itself for the reality of impending future regulation.