Any Notified Body accredited under sub-rule (1) sh...

Any Notified Body accredited under sub-rule (1) shall, if it intends to carry out audit of a manufacturing site of Class A 3 [(other than non-sterile and non-measuring)] or Class B of medical devices in accordance with sub-rule (2), register with the Central Licensing Authority. (4) Any Notified Body under sub-rule (3), with an experience of at least two years, may apply to the Central Licensing Authority for registration as a Notified Body for carrying out audit of Class C and Class D medical devices, provided it has personnel with requisite qualification and experience. (5) With effect from the 1st day of the July, 2017, the Notified Body accredited in accordance with sub-rule (3) may make an application to the Central Licensing Authority for registration in Form MD-1 through online portal accompanied with a fee specified in the Second Schedule along with documents as specified in Part I of the Third Schedule.