Maintenance of records.― (1) The manufacturer or, as the case may be, importer shall maintain the records relating to manufacturing or importing along with its sales or distribution. (2) The manufacturer or, as the case may be, importer shall produce the records, labels, instructions for use, on request by Licensing Authorities. (3) The Licensing Authorities may verify the records and documents referred to in sub-rule (2) at any point of time and investigate quality or safety related failures or complaints. 19M. Cancellation or suspension of registration.― (1) The State Licensing Authority or the Central Licensing Authority, as the case may be, may, after giving the registrant an opportunity to show cause as to why such an order should not be passed, by an order in writing stating the reasons thereof, cancel the registration number generated under the provisions of rule 19-I or rule 19K, or suspend it for such period as the Licensing Authority thinks fit, either wholly or in respect of any of the medical devices to which it relates, if in its opinion, the registrant has failed to comply with any of the provisions of the rules under this Chapter; (2) Any person who is aggrieved by an order passed by the State Licensing Authority or the Central Licensing Authority, as the case may be, may, within forty-five days of the receipt of a copy of such order, prefer an appeal to the State Government or the Central Government, as the case may be, and the State Government or the Central Government, shall after giving the said appellant an opportunity of being heard, confirm, reverse or modify such order.]
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