(b) a pivotal clinical investigation on an investigational medical device shall be ma ...

All relevant clinical and non-clinical safety data will cover only the period of the ...

Performance evaluation report from a laboratory designated under subrule (1) of rule ...

Responsibilities of Sponsor: (i) The sponsor is responsible for implementing and main ...

(b) If the in vitro diagnostic medical device contains any of the following then desc ...

Post Marketing Surveillance: (i) Subsequent to approval of an Investigational medical ...

DUTIES AND FUNCTIONS OF NOTIFIED BODY 1. Duties: 1. Notified body shall perform the a ...

(ii) Directors, executives and personnel responsible for carrying out evaluation and ...