Investigational medical device and methods 6.1 Investigational medical device descrip ...

INFORMED CONSENT FORM 1. Checklist for clinical investigation Subject's informed cons ...

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

Central medical device testing laboratory (1) The Central Government may, by notifica ...

Existing clinical data (a) Summary of relevant previous clinical experience with the ...

Disclosure of name, address, etc., of persons involved in clinical investigation or ...

APPLICATION FOR GRANT OF LICENCE TO MANUFACTURE FOR SALE AND DISTRIBUTION OF CLASS A ...

Preclinical testing Summary of preclinical testing that has been performed on the i ...