(1) Where the licence holder contravenes any provision of these rules, the State Licensing Authority or the Central Licensing Authority, as the case may be, may, after giving the licence holder an opportunity to show cause why such an order should not be passed, shall by an order in writing including the reasons thereof suspend it for such period as it thinks fit either wholly or in respect of any of the medical device or cancel the licence or loan licence.
(2) A licence holder whose licence or loan licence has been suspended or cancelled by the State Licensing Authority or Central Licensing Authority, as the case may be, under sub-rule (1), may within sixty days of the receipt of a copy of the order by him, prefer an appeal to the State Government or Central Government, as the case may be, and State Government or the Central Government, as the case may be, may after giving the licence holder an opportunity of being heard, confirm, reverse or modify such order.
(3) Any licence suspended in accordance with these rules shall not be revoked by the State Licensing Authority or the Central Licensing Authority without a detailed written order indicating the reasons for such suspension and the extent of compliance vis-à-vis the deficiencies that led to suspension and publishing the order on its website.
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(4) All orders of suspension issued or revoked or cancellation of licence shall be duly published on the websites of the State Licensing Authority concerned and the Central Licensing Authority.
(5) The State Licensing Authority or the Central Licensing Authority, as the case may be, may order destruction of such stock of medical device in the presence of a Medical Device Officer, if in its opinion, the licence holder has failed to comply with any of the conditions of the licence or loan licence or with any provisions of the Act or rules made thereunder.
Product Standards for medical device.
26. The medical devices shall conform to the standards,-
(1) laid down by the Bureau of Indian Standards established under section 3 of the Bureau of Indian Standards Act, 1985 (63 of 1985) or the Central Government from time to time;
(2) If there is no relevant Standard laid down by the Bureau of Indian Standard or the Central Government, then it shall conform to the standard laid down by International Organisation for Standards (ISO) or other Pharmacopeial standard;
(3) In case, national or international standards are not available, the device shall conform to the manufacturer’s standards which are validated.
Manufacturing of medical devices for clinical investigation, test, evaluation, examination and demonstration.