To carry out verification work on Yixie registration notice of the matter - Drug Administration, medical equipment - Medical Devices Industry
To carry out verification work on Yixie registration notice of the matter - Drug Administration
, medical equipment - Medical Devices Industry
Registration of medical devices in order to further strengthen the supervision and management, standardized reporting of medical device registration, order, and effectively protect public safety and effective use of firearms, according to the "State Council to strengthen food safety supervision and management products such as special provisions" (State Council Decree No. 503), " State Council on Further Strengthening the drug safety supervision work of the notice "(SCS 2007 18) and the State Food and Drug Administration," issued in rectifying and standardizing the drugs on the development, production and circulation of the program of work notice "(State Food Drug Administration's Office 2006 No. 465) and other documents, the State Food and Drug Administration decided that the rectification of the preceding medical devices based on registration of medical devices continue to conduct the verification. The matter now announced as follows:
One, from September 18, 2007, the State Food and Drug Administration will be asking the provinces (autonomous regions and municipalities) food and drug supervision and management of the State Food and Drug Administration within the proposed Class III medical devices registration, especially first-time registration to verify the application information. All to the State Food and Drug Administration proposed Class III medical devices within the application for registration of manufacturers, the information in the submission of applications for information to be submitted simultaneously to the original and one copy.
Which, on the need for verification of applications for registration information, the State Food and Drug Administration application for enterprise information submitted by the Applicant send a copy of provinces (autonomous regions and municipalities) food and drug supervision and management department for verification. Provinces (autonomous regions and municipalities) food and drug supervision and management information copy of the receipt of an application for registration shall, within 30 working days to complete verification of the authenticity of applications for registration information and issue a verification report. Verification report in duplicate, one copy sent to the State Food and Drug Administration Medical Devices Evaluation Center, another into enterprise applications for registration information submitted by a copy of the file.
II, from September 2007, the State Food and Drug Administration has accepted and not completed review of all approved Class III medical devices within the application for registration, materials, and applications for registration of medical devices outside of the authenticity of the information verification. Confirmed to be verified after review and approval.
Three, from September 2007, the State Food and Drug Administration has got the registration certificate of the part of the three types of medical devices (mainly cardiac pacemakers, heart valves, vascular stents, artificial joints, etc.) applications for registration information to verify the authenticity.
4, confirmed by the verification of applications for registration of medical devices there is false information in such problems, the food and drug supervision and management departments will be based on relevant laws, regulations, investigated and dealt with bad records credited producers. On a typical case of serious illegal, investigation results will be announced, be made public.
5, the production company found through self-examination and correction of medical device registration information problems, and can take the initiative to withdraw has been received and is reviewing the related application for registration of medical devices, or take the initiative to write-off related to health care have been allowed to register Device Registration Certificate.
Six provinces (regions and municipalities) food and drug supervision and management departments to implement medical device registration information verified the authenticity of the request by the State Food and Drug Administration separately.
Hereby. State Food and Drug Administration
SFDA
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To carry out verification work on Yixie registration notice of the matter - Drug Administration, medical equipment - Medical Devices Industry