MANUFACTURE OF MEDICAL DEVICES FOR SALE OR FOR DISTRIBUTION 20. Application for manu ...

Duties of Notified Body A registered Notified Body, referred to in rule 13, shall car ...

PROVIDED that, — (i) no audit of the manufacturing site shall be necessary prior to g ...

Any Notified Body accredited under sub-rule (1) shall, if it intends to carry out au ...

The Notified Body shall perform the functions as specified in Part II of the Third S ...

FORM MD-1 [Refer sub-rule (5) of rule 13] APPLICATION FOR GRANT OF CERTIFICATE OF RE ...

In case of application for grant of licence or loan licence to manufacture for sale ...

THIRD SCHEDULE [Refer rules 13(5), 13(9), 14, 15, 20(4), 20(6)] DOCUMENTS REQUIRED FO ...