Officially Effective! China’s New Medical Device Regulation (Order 739)

On June 1st, 2021, the newly revised Regulation on the Supervision and Administration of Medical Devices (Order 739 issued by the State Council) entered into force in China. Order 739 is the fundamental of all medical device/IVD regulations & guidelines in China. Manufacturers shall comply with Order 739 for all regulatory, clinical, manufacturing, and commercialization activities in China. 

Major changes in Order 739 focus on the following aspects:

• New Exemptions
• New Regulatory Pathways
• New Clinical Pathways
• Manufacturing Authorization Holder (MAH) Regime
• Increased Administrative Penalties for Illegal Conduct
• Repositioning of Local Legal Agent

Check out Inspirative Medical’s webinar on Order 739 Updates Here

Following Order 739, the National Medical Product Administration (NMPA) is organizing the formulation and revision of supporting regulations, normative documents, and technical guidelines. More draft and official documents will be released in the next few months.