Mandatory Registration Scheme for Non-Notified Medical Device in India

By Fajar Dumadi | October 20, 2021

Non-notified medical devices were non regulated products; therefore, registration certificate was not required.

According to the Medical Device (Amendment) Rules – February 2020 (1), which was enforced in April 2020, all non-notified medical devices can be voluntarily registered with the Central Licensing Authority (CLA) through the online system for medical devices.

However, the transitional grace period to implement this rule was only given until 30 September 2021 which means that the registration will become mandatory afterward. Therefore, non-notified medical devices must obtain full device registration/import license as mandated by Medical Device Rules 2017 by the following timeline:

– Class A and B devices – 30 months

– Class C and D devices – 42 months

In addition to this, CDSCO has provided a guidance (2) for the registration of non-notified medical devices. They also issued a list of medical devices (3) and IVDs (4) that fall under non-notified medical devices including its product risk classification.