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

The application under sub-rule (1) shall be made through an identified online portal ...

BIO-COMPATIBILITY AND ANIMAL PERFORMANCE STUDY FOR INVESTIGATIONAL MEDICAL DEVICE 1. ...

Duties of Medical Device Officer Subject to the instructions of the Central Licensing ...

(iii) a table compiling all observed device deficiencies that could have led to a ser ...

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

IMPORT OR MANUFACTURE MEDICAL DEVICE WHICH DOES NOT HAVE PREDICATE DEVICE 63. Permis ...

. Registration of medical device testing laboratory (1) Before grant of registration ...