PROVIDED that in case of large sized medical device, wherein the opinion of the Medic ...

Duties of Medical Device Officer Subject to the instructions of the Central Licensing ...

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

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

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

(ii) Directors, executives and personnel responsible for carrying out evaluation and ...

DUTIES AND FUNCTIONS OF NOTIFIED BODY 1. Duties: 1. Notified body shall perform the a ...

Conditions for manufacturing licence or loan licence After grant of licence or loan l ...