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Medical device registration and filing

Chapter II medical device registration and filing

Article eighth class I medical device product management, class II and class III medical device product registration management.

Nineth class I medical device product filings and applications for class II and class III medical device product registration, shall submit the following information:

(A) risk analysis for product information;

(B) the product specification;

(C) the inspection reports;

(D) clinical evaluation of information;

(E) the product specification and labelling artwork;

(Vi) relating to product development, production and quality management system documentation;

(G) other information required to prove that products are safe and effective.

Medical device registration applicant, filing shall be responsible for the authenticity of the data.

Article tenth class I medical device product record, location of the filing to the district people's Government municipal food and drug supervision and management departments to submit filings. Among them, the product inspection report can be filed the self-test report clinical data do not include clinical trial reports, can be through literature, similar products clinical data shows that the medical device is safe and effective information.

Exports to China overseas manufacturers of class I medical devices, represented by its set up in our institution or corporation as an agent of the specified country, food and drug supervision and Management Department under the State Council to submit filings and filing in the country (region) authorities to allow the sale of medical devices documents.

Filings contained items change, should be changed to the original filing department record.