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About publishing application for cancellation of the registratio
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To clear production enterprises active application log off its medical device registration certificate of the matter, I Council enacted the apply for cancellation of the registration certificate of medical procedures, is released, promulgation.
The State food and drug administration
2007 October 22
Apply for cancellation of the registration certificate for programs of medical devices
Project name: apply for cancellation of the registration certificate of medical devices
Justiciable: production enterprises apply cancellation is within its validity period of the third kind, overseas medical device registration certificate.
Fees are not charged pursuant to:
Go through the conditions:
A domestic product registration certificate cancellation: production enterprises, owners of enterprises by the production or the enterprise registration transaction clerk formalities.
Second, the offshore product registration certificate cancellation: production enterprises, by production enterprise on the territory of the agent responsible person or agent registration transaction clerk formalities.
Application materials requirements:
A domestic product registration certificate cancellation request
1. a production company to produce a certificate of registration of medical device logoff and factsheets.
2. production qualification documents: business license and copy of production enterprise license.
3. the original of the certificate of registration of medical devices.
4. the production of business leaders identity cards (for the production of business leaders; or production enterprises of this enterprise registration transaction clerk of authorization and the transactor photocopy (non-production business leaders do).
5. the information provided by the manufacturers of self assurance statement: includes a list of materials submitted, as well as production enterprise of commitment.
Second, the offshore product registration certificate cancellation request
1. a production company to produce a certificate of registration of medical device logoff and factsheets.
2. production qualification documents of public documents.
3. the original of the certificate of registration of medical devices.
4. production enterprises Attorney, agent license (registration certificate) or agencies and agents in charge of your ID card (production enterprises in charge of handling within the agent; or production enterprises Attorney, agent license (or registration certificate), the agent registration transaction clerk of authorization and the transactor photocopy (non-production enterprise on the territory of the agent responsible for).
5. the information provided by the manufacturers of self assurance statement, including a list of submitted materials, as well as production enterprise of commitment.
Handling the program:
First, the State food and Drug Administration Executive accepted the Service Centre Manager in accordance with the appropriate application data requirements on logoff request data to the application data requirements, it should be dealt with in accordance with the relevant provisions of the proceedings for surrender, the application for transfer of State food and drug administration, the Secretary for medical devices.
Second, medical equipment for receiving information on his behalf, shall be within 5 business days after verification of the situation and draw up a notice sent to the competent unregistered Director review.
3. request for information from the competent Commissioner Attn served on the Executive Director shall, within four working days to produce review comments, to be given to the supervisor's approval.
Fourth, in charge of the Secretary should be issued within four working days to approve comments are off decision.
Fifth, the validation is complete, it should be in three working days after the date of publication and notification of cancellation notice, modify the relevant system information center.
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