Unified process for Class 1 devices

As of August 07, 2024, the Medical Device Act has been amended to unify the registration pathway for Class 1 devices into a universal 5-day process, eliminating the possibility of review as a non-SE product, given that the low riak assosiated with Class 1 devices.

Before this amendment, Class 1 devices could follow an 80-day non-SE pathway, which required submission of clinical trial report - a very demanding process.

The amendment comes into effect from the notification date of August 07, 2024.