Clinical investigation team Briefly describe the administrative structure of the clin ...

Application for grant of permission to conduct clinical investigation (1) An applicat ...

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

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

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

Maintenance of record Every person, sponsor, clinical research organisation, any oth ...

BIO-COMPATIBILITY AND ANIMAL PERFORMANCE STUDY FOR INVESTIGATIONAL MEDICAL DEVICE 1. ...

Presentation of individual case histories: This section of PSUR shall include the ind ...