India: Additional steps for registration of Innovative Medical Devices

ARQon
Sep 30, 2022
2 min read

Importers for Voluntary

The Ministry of Health and Family Welfare published the Medical Device Rules on February 11th, 2020, as an amendment to the Medical Device Rules, 2017 providing for the voluntary registration of all non-notified medical devices over a 18-month period with the Central Drugs Standard Control Organization (CDSCO). These Medical Device Rules, 2020 will come into full effect on April 1, 2020. The 18-month voluntary phase starts from April 1, 2020 and ends on October 1, 2021.

Mandatory Registration of Medical Devices

All class A and B devices would have a further 12 months to register (i.e., by October 1, 2022) in the CDSCO's online portal following the optional period (i.e., from October 1, 2021). Devices in Classes C and D would have an additional 24 months to comply with the same criterion (i.e., by October 1, 2023).

Registration Process

Documents such as an ISO 13485 certificate, a free sales certificate from country or origin and details of medical devices are required for registration. The voluntary registration process is free from processing fees from the government and never expires, but it may be cancelled or suspended by the CDSCO if there are questions about the product's safety or if it is replaced by the requirement for the mandatory Import License in accordance with the phases and timelines mentioned in the paragraph above. Once voluntary registration is completed, the local registration holder will be required to notify the CDSCO and Materiovigilance Programme of India (MvPi) of Serious Adverse Events (SAE) occurring in India.

All medical devices will be notified and regulated in India commencing on April 1st, 2020, in accordance with notifications made on February 11, 2020.

Manufacturers of presently non-notified medical devices are recommended to evaluate their products of interest for India and start assembling their application files for voluntary registration as per state timelines.

Source:

https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/Guidance-document-for-Registration-of-Non-Notified-Medical-Devices..pdf