Conditions of registration certificate to sell, stock, exhibit or offer for sale or distribute a medical device including in vitro diagnostic medical device.— (1) The registration certificate granted under rule 87A shall be displayed at a prominent place in the premises visible to the public. (2) The registration certificate holder shall provide adequate space and proper storage condition for storage of the medical devices. (3) The registration certificate holder shall maintain requisite temperature and lighting as per requirements of such medical devices. (4) The medical devices shall be purchased only from importer or licensed manufacturer or registered or licensed entity. (5) Separate records, in the form of invoice or register or electronic details including software of purchases and sales of medical devices showing the names and quantities of such medical devices, names and addresses of the manufacturers or importers, batch number or lot number and expiry date (if applicable) shall be maintained. (6) The records referred to in sub-rule (5) shall be open to inspection by a Medical Device Officer appointed under the sub-rule (2) of rule 18, who may, if necessary, make enquiries about purchases and sale of the medical devices and may also take samples for testing. (7) All registers and records mentioned under these rules, shall be preserved for a period of not less than two years from the last entry, therein. Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India. (8) The registration certificate holder shall maintain an inspection book in Form MD-43 to enable the Medical Devices Officer to record his observations and defects noticed.
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