If the medical device is intended to treat serious or lifethreatening diseases, occu ...

All relevant clinical and non-clinical safety data will cover only the period of the ...

DESIGN ANALYSIS DATA Design Analysis Data for a medical device shall include the foll ...

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

Definitions In these rules, unless the context otherwise requires, — (a) "academic cl ...

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

Drugs and Cosmetics Act, CDSCO is responsible for approval of New Drugs, Conduct of C ...

Details of suspected adverse device reaction(s): (a) Full description of reaction(s) ...