28. Unannounced inspection by State Licensing Authority.
- The State Licensing Authority shall, in cases where licence has been granted for manufacturing Class A and Class B medical devices under rule 20, cause an inspection of the manufacturing site to be carried out by a Medical Device Officer on a random basis and such inspection shall not be less than two per cent. of the total audits carried out by Notified Bodies within that State for that class of medical device.
