On 30-09-2022, the Central Government, after consultation with the Drugs Technical Advisory Board, notified Medical Devices (Fifth Amendment) Rules, 2022 to amend the Medical Devices Rules, 2017. The Rules provides that any person not holding licence and intends to sell medical devices exclusively must obtain registration certificate.
Key points:
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The Amendment inserts a new rule providing Registration certificate to sell, stock, exhibit or offer for sale or distribute a medical device including in vitro diagnostic medical device. The registration certificate will be issued by Licensing authorities appointed by the State Licensing Authority.
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An application to sell, stock, exhibit or offer for sale or distribute a medical device including in vitro diagnostic medical device, must be made in Form MD-41 to the State Licensing Authority for grant of registration certificate.
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The registration certificate holder must display the certificate at a prominent place in the premises visible to the public and must provide adequate space and proper storage condition for storage of the medical devices.
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All registers and records under the Rules must be preserved for a period of not less than two years from the last entry, therein.
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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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A registration certificate issued in Form MD-42, shall remain valid in perpetuity, subject to payment of registration certificate retention fee as specified in the Second Schedule, before completion of the period of five years from the date of its issue, unless, it is suspended or cancelled by State Licensing Authority.
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Where the registration certificate holder contravenes any provision of the Act or these rules, the State Licensing Authority, shall, after giving the registration certificate holder an opportunity to show cause as to why such an order should not be passed, by an order and for reasons to be recorded in writing, suspend it for such period as it considers necessary either wholly or in respect of any of the medical device or, as the case may be, cancel the registration certificate.
