- Subject to the instructions of the Central Licensing Authority or State Licensing Authority, as the case may be, it shall be the duty of Medical Device Officer to,-(i)Inspect, not less than once in a year, all manufacturing sites licenced by the Central Licensing Authority or State Licensing Authority, as the case may be, within the area assigned to him;(ii)conform that the conditions of licence are being observed;(iii)take samples of medical device manufactured or imported for sale, or stocked or exhibited for sale in respect of which the Medical Device Officer has reason to suspect contravention of the provisions of the Act or these rules and send them for test or evaluation:Provided that in case of large sized medical device, wherein the opinion of the Medical Device Officer drawing samples of such a device may not be physically practical, such large sized medical device shall be inspected at the place where these are kept by the Medical Device Officer with or without expert and evaluated or tested by the Medical Device Testing Officer, for any suspect contravention, after approval of the Central Licensing Authority or the State Licensing Authority, as the case may be;(iv)maintain a record of all inspections undertaken, drawing of samples, seizure of stocks and action taken by Medical Device Officer in exercise and performance of duties and to furnish copies of such record to the Central Licensing Authority or the State Licensing Authority, as the case may be;(v)make such enquiries and inspections as may be necessary to detect the manufacture or sale of medical device in contravention of any provision of the Act and these rules;(vi)investigate any complaint made in writing relating to medical device to the Medical Device Officer or any other senior officer in accordance with the direction of the controlling officer;(vii)institute prosecution in relation to contravention of the provisions of the Act and these rules;(viii)review technical dossier of medical device furnished with the application under these rules or any other duties assigned by the Central Licensing Authority or State Licensing Authority, as the case may be, related to these rules.
