Informed consent: (i) In all investigations, a freely given, informed, written consen ...

If the medical device is intended to treat serious or lifethreatening diseases, occu ...

Where a subject is not able to give informed consent (e.g. an unconscious person or ...

Responsibilities of the Ethics Committee: (i) It is the responsibility of the Ethics ...

UNDERTAKING BY THE INVESTIGATOR 1. Full name, address and title of the Principal Inv ...

Types of Case Report Forms The following is a suggested list of CRFs that may be deve ...

Vulnerable population (a) Description of the vulnerable population. (b) Description o ...

REQUIREMENTS FOR PERMISSION TO IMPORT OR MANUFACTURE INVESTIGATIONAL MEDICAL DEVICE ...