Fast-track registration of medical devices

Apart from the general registration scheme within the Russian medical device market, there are several fast-track regulatory options available. 

Each can be applied to different products and situations:

1 - Order of Russian Government 430 - offers a time-limited registration certificate option, initially designed for pandemic products required during COVID-19. It can be utilised for products listed in the appendix to the Order, with specific requirements for technical dossier and sample importation.

2 - Order of Russian Government 299 - provides a registration certificate without an expiry date, primarily for low-risk class products.

3 - Order of Russian Government 552 - offers a time-limited registration certificate, applicable to products listed in a special appendix to the Order.

Let's delve into each process in detail.