DEVICE MASTER FILE FOR MEDICAL DEVICES OTHER THAN IN VITRO DIAGNOSTIC MEDICAL DEVICE ...

DEVICE MASTER FILE FOR IN VITRO DIAGNOSTIC MEDICAL DEVICES 1.0 Executive Summary An ...

1.1 Introductory descriptive information on the in vitro diagnostic medical device, t ...

Form of receipt for samples of medical devices where fair price tendered is refused ...

Purpose for which samples have been taken When a Medical Device Officer takes a sampl ...

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

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

POST APPROVAL CHANGE (A) Changes in respect of following shall be considered as major ...