Ethics Committee This section shall document that the clinical investigation was cond ...

Application of rule 122DD of Drugs and Cosmetics Rules, 1945 with regard to Ethics Co ...

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

(1) "clinical investigation" means the systematic study of an investigational medical ...

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

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

For clinical investigations conducted in paediatric population, the reviewing Ethics ...

PROVIDED that no fee shall be required to be paid by the institutes, organisation, h ...