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

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

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

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

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

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

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

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