DRAFT RULES
Registration Certificate to sell, stock, exhibit or offer for sale or distribute a medical device includingin vitrodiagnostic medical device.—
- 国家许可机关任命表示“允许”ing Authorities for the purpose of issuing Registration Certificate in this Part for such areas as may be
- Any person who intends to sell, stock, exhibit or offer for sale or distribute a medical device includingin vitrodiagnostic medical device shall make an application in Form MD-41 for grant of Registration Certificate to sell, stock, exhibit or offer for sale or distribution to the State Licensing
- The application made under sub-rule (2), shall be accompanied with
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- a fees prescribed in Second Schedule of the said rules;
- Self certificate of compliance with respect to Good Distribution Compliance;
- Brief description on other activities carried out by applicant,viz: storage of drugs, medical items, food products, stationeries etc or any other activities carried out by applicant in the said
- The application made under sub-rule (2), shall be accompanied with an undertaking to the effect that the storage requirements to sell, stock, exhibit or offer for sale or distribute a medical device will be complied.
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Conditions of registration certificate to sell, stock, exhibit or offer for sale or distribute a medical device includingin vitrodiagnostic medical device.—
- The Registration Certificate shall be displayed at a prominent place in the premises visible to the public.
- The Registration Certificate holder shall provide adequate space, proper storage condition for storage.
Suspension and cancellation of Registration Certificate.—
- 登记证持有人,contrav吗enes any provision of the Act and the said 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, shall 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 cancel the Registration
- A Registration Certificate holder whose Registration Certificate has been suspended or cancelled by the State Licensing Authority under sub-rule (1), may within forty-five days of the receipt of a copy of the order by such authority, prefer an appeal to the State Government or Authority designated by the State Government, and the State Government or Authority designated by the State Government , shall after giving the Registration holder an opportunity of being heard, confirm, reverse or modify such order, with reasons to be recorded in ”