(iv) the person holding registration certificate shall maintain records of tests for evaluation and performance carried out on all samples of medical devices and the results thereof together with protocols of tests and the reports showing readings and calculations and such records shall be retained, in case of substances for which an expiry date is assigned, for a period of two years beyond the expiry date, and in the case of other substances, for a period of six years; (v) the person holding registration certificate shall allow the medical device officer appointed under this Act to enter, with or without prior notice, the premises where the testing is carried out and to inspect the premises and the equipment used for test and the testing procedures employed; (vi) the person holding registration certificate shall allow the medical device officer to inspect records maintained and shall make available such information as may be required for ascertaining whether the provisions of the Act and these rules have been complied with;
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