Medical Devices

Popular beauty devices are classified as medical devices according to the classification catalogue in China

Biocompatibility testing is the one test that can be done outside of China provided it complies with the GB/T 16886 and ISO 10993 standards.

The NMPA (National Medical Products Administration) issued the Catalogue of Technical Guidelines for Reviewing Medical Device Registrations.

The catalogue covers 1,791 medical industry standards that are currently in effect. 77 industry standards will be revised this year.

List of institutions qualified for conducting clinical trials and also completed the filing application to be listed in the NMPA database.

New revised law on the Supervision and Administration of Medical Devices (Order 739) issued by the State Council came into force in June 2021

5 new technical medical device guidelines whilst there were 4 guidelines implemented and 6 drafts are announced by NMPA

The Center for Medical Device Standardization Administration issued the notice to solicitate proposals for amending medical device standards in China

The NMPA is currently soliciting public comments on the draft documents. The public consultation period is open until May 30, 2021.

883 commodities were announced under the MFN Rate of Duty whilst the import tariff rate on artificial heart valve, hearing aids, etc., reduced from 4% to 1%

The China NIFDC announced the technical guidelines (draft) for Radio Frequency beauty devices to be regulated as class II or class III medical devices.

Our testing engineers are specialized in EMC (Electro Magnetic Compatibility), electrical safety, physical and chemical property and biocompatibility tests.