2023-07-18T04:23:38
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.
Have a question? Ask here!
Required fields are marked *