As per the Ministry of Health & Family Welfare, there has been a recent amendment in the Medical Device Rules, 2017[1]. The Official Gazette G.S.R. 102 (E) was made public on 11th February 2020. It notified that the medical devices must be registered with the Central Licensing Authorities via an online portal, which CDSCO regulates. The registration was voluntary only for eighteen months from the date of the notice. However, the deadline for Voluntary Registration of Medical Device of Class A and B has been extended to 1st October 2022. Whereas the deadline for Voluntary Registration of Medical Device of Class C and D has been extended to 1st October 2023.
Overview of Medical Device Rules, 2017
The Central Drugs Standard Control Organization or CDSCO is the highest regulatory body in India that monitors Medical Device regulations. CDSCO is responsible for approving licences to import and manufacture medical devices in India. The Medical Device Rules, 2017 were notified by the CDSCO to regulate the import, sale, distribution, production, and clinical trials, among other things. Additionally, the medical devices have been divided into four classes based on the risk associated with each device. The following is the classification of medical devices based on risk:
- Class A medical devices- Low-Risk
- Class B medical devices – Low- Medium Risk
- Class C medical devices – Medium- High-Risk
- Class D medical devices – High-Risk
On 11.02.2020, the Central Government issued two notifications-
- S.O. 648(E) -New definition of medical devices
- GSR 102(E) – The Medical Devices (Amendment) Rules, 2020, amending the Medical Devices Rules, 2017. It has become effective from 1st April 2020
The Central Government widened the scope of the definition of Medical Devices vide its notification dated 11.02.2020, effective from 01.04.2020.
According to the new S.O. 648(E), from 1st April 2020, all medical devices, comprising all apparatus, material, or appliance, etc. for any intended purpose, invasive/non-invasive, used directly/indirectly in human/animal, has been included under the definition of Medical Devices. Until 11th February 2020, only 37 categories of medical devices were regulated or notified as drugs.
The second notification issued on 11.02.2020 was GSR 102(E) amending the Medical Devices Rules 2017. According to it, the manufacturers or importers of Medical Devices will be required to compulsorily register their medical devices with the DCGI. The DCGI will begin accepting applications for registration via a dedicated online portal called ‘Online System for Medical Devices’ (established by Central Drugs Standard Control Organisation) on 1st April 2020. Suppose an importer or manufacturer cannot obtain registration for their medical device before the given timeline. They will not be able to market and sell their medical device in India until registration is received.
Documents Required for Voluntary Registration of Medical Device
The documents which must be uploaded on the portal by the Manufacturer for Voluntary Registration of Medical Device are as follows-
- Name and Address of the company, firm or manufacturing site
- Details of the medical device, such as-
- Generic Name
- Brand Name
- Model no.
- Intended use
- Class of medical device
- Material of Construction
- Dimension
- Shelf life
- Sterile or non-sterile
- Certificate of compliance with ISO 13485 standard for such medical device, accredited by National Accreditation Board for Certification Bodies or International Accreditation Forum
- Undertaking signed by the manufacturer specifying that the information furnished by the applicant is genuine and authentic.
The documents which must be uploaded on the portal by the Importers for Voluntary Registration of Medical Device are as follows-
- Name of the company, firm or any entity importing the medical device
- Details of the medical device, such as-
- Generic Name
- Brand Name
- Model no.
- Intended use
- Class of medical device
- Material of Construction
- Dimension
- Shelf life
- Sterile or non-sterile
3. Certificate of compliance with ISO 13485 standard for such medical device, accredited by National Accreditation Board for Certification Bodies or International Accreditation Forum.
4. Free Sale Certificate from Country of Origin.
5. An undertaking from the importer that the applicant’s information is accurate and true.
Procedure for Voluntary Registration of Medical Device
According to Rule 19C and 19E of Chapter IIIA of the Medical Devices (Amendment) Rules, 2020, the manufacturer or importer must upload the required documents on the online portal. CDSCO will then generate the registration number for the medical device. After furnishing the details uploaded on the “Online System for Medical Devices”, The Manufacturer and Importer shall receive the registration. They must also mention the obtained registration number on the device’s label.
The procedure of voluntary registration can be followed only for non-notified medical devices. The applicant must follow the following procedure for Voluntary Registration of Medical Device-
- The applicant must first visit the online portal on the official CDCSO website
- Next, the applicant must click on the registration link from the portal to proceed
- Upon clicking the link, the applicant must then register their Name, Email ID and Mobile number
- After that, the applicant must upload the following documents-
- I.D. proof
- Undertaking
- Corporate Address Proof Details (Certificate of Incorporation of the company)
- Copy of Manufacturing and Wholesale License
5. After uploading the details, the applicant shall be required to verify the registration through a 4-digit OTP received on the registered mobile number
6. After registration, the applicant will be able to login into the account
Time period and validity of Voluntary Registration of Medical Device
Per the guidance document published by CDSCO on 21st September 2021, the time validity of Voluntary Registration of Class A and B medical devices will be till 30th September 2022. From 1st October 2022, class A and B medical device registration will be mandatory. Class A and B device registration is first voluntary for 18 months; then, it will be required for 12 months. The time validity of voluntary registration for class C and D medical devices will be till 30th September 2023. From 1st October 2023, registration will be made mandatory. After 18 months of voluntary registration, The manufacturers or importers must register Class C and D devices for 24 months.
Rejection of Voluntary Registration of Medical Device
After giving the registrant the chance to explain why their registration should not be rejected or suspended, the Central Licensing Authority may cancel or suspend the registration number for a specific time. This could happen if the registrant fails to meet the rules’ requirements. The CLA can also check the document at any time to look into the issue.
Conclusion
The government has notified in an official notice regarding voluntary registration for medical devices to ensure that good quality and standards of products are introduced to the market. The voluntary registration shall apply to non-notified medical devices till the officially announced deadline. After the deadline is crossed, all medical devices shall fall into the category of mandatory registration.
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