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  • ADD:NO.4 Baolong 6th Road,Baolong industrial Town,Longgang District,Shenzhen ,P.R.China
  • Medical device product registration and filing
    Jan 12, 2018

    For the record of the first type of medical device products, the filing person submits the record data to the food and drug administration department of the municipal people's government located in the district where the location is located. The product test report may be a self-test report of the record holder; the clinical evaluation data do not include the clinical trial report, and may be data that is obtained through clinical use of the literature or similar products to prove that the medical device is safe and effective.

    An overseas manufacturing enterprise that exports the first type of medical device to our country shall, as its representative, set up its territory in China or an enterprise legal person designated in the territory of our country as its agent, submit to the State Food and Drug Administration of the State Council the information for the record and the country where the record holder is located Area) The competent authority to allow the medical device to be listed for sale.

    Any change in the matters stated in the record filing shall be filed with the original record filing department.