(v) "intended use" means the use for which the medical device is intended according t ...

Overall synopsis of the clinical investigation A summary or overview of the clinical ...

Sponsor or manufacturer Name and address of the sponsor or manufacturer of the inves ...

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

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

AUTHORITIES, OFFICERS AND BODIES 8. Licensing Authorities (1) The Central Licensing A ...

If the application for grant of licence or loan licence to manufacture for sale or fo ...

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