Import License:
Required Documents for the Registration Process
1- Manufacturing License
2- Free Sale Certificate
3- Free Sale Certificate (From EU, USA, Australia, Canada, Japan)
4- ISO 13485:2016
5- CE Certificate
6- CE Design Certificate
7- Declaration of Conformity
8- Audit report of the premises
9- Device Master File as per Medical Device Rules, 2017
10- Plant Master File as per Medical Device Rules, 2017
