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Guangdong’s Medical Device Registration System Gets State Assent

Guangdong’s new medical device registration system has now been given official approval. In line with this, enterprises will be permitted to register, manufacture, market and sell such devices without having to apply for a specific business permit or having to file additional records or registration details.

The official endorsement of the scheme – as outlined in the Implementation Plan of Guangdong Province for the Pilot System of Medical Device Registrants – came courtesy of the National Medical Products Administration, the state body with overall responsibility for the sector. It is now hoped that this new initiative will improve the approval and registration system for medical devices in several key areas:

  • Parties applying for medical devices registration will be approved once the appropriate registration certificate has been secured. The registrants shall market the medical devices in their own names and bear legal responsibility for all such products throughout their life cycle 
  • Enterprises applying to register medical devices from within the Guangdong Pilot Free Trade Zone or those based elsewhere in Guangzhou, Shenzhen or Zhuhai may subcontract the manufacturing of sample devices to enterprises in Guangdong
  • Registrants may undertake production themselves or appoint a third-party enterprise to undertake the required manufacturing procedures
  • Registrants may sell the medical devices themselves without applying for business permits or filing records. They may also appoint qualified third parties as their sales agents

For further details (in Chinese), please access the following link:

Implementation Plan of Guangdong Province for the Pilot System of Medical Device Registrants

Content provided by Picture: HKTDC Research
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