Regulatory News from Across Asia-Pacific

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 regulatory draft imposes stricter controls and raises the safety standards on Children's cosmetics under the age of 12.

Grace period will be around 11 months for new applicants, and around 23 months for applicants with approvals before May 1, 2022.

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

On May 7, 2021, the NMPA issued the notice regarding the transition from old to new platforms for cosmetics registration and filing.

In accordance with the CSAR, the NMPA addressed the details of the information needed to support the application of cosmetics registration and filing.

The first edition of the new IECIC list was last updated in 2015 and now covers 8792 cosmetic ingredients.

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.

Identifying the key trends, market opportunities and latest regulatory updates of the digital healthcare sector in China and relevant regulatory framework.

The China GAC issued 2 administrative measures for the safety of imported and exported food products and for the registration of overseas manufacturers.

The NIFDC launched a public consultation to solicit comments on prohibiting CBD and other ingredients for cosmetics in China.

The NMPA published a Q&A article to relieve the concerns of the cosmetics industry on the registration and filing procedures in China.