Medical Device Supervision and Administration Regulations β Order No. 739 (2021)
State Council Order No. 739 β the Medical Device Supervision and Administration Regulations (MDSMAR) β came into force on 1 June 2021, replacing the 2017 version. The NMPA (National Medical Products Administration) implements the regulations, which establish China's comprehensive framework for medical device registration, manufacture, distribution, and post-market surveillance.
Key provisions of Order No. 739:
- Three-tier risk classification: Class I (lowest, filing), Class II (registration with provincial/municipal NMPA), Class III (registration with national NMPA β highest scrutiny).
- Strengthened clinical evidence: Clinical trials or clinical evaluation by literature/equivalent comparison required for Class II and III; exemptions allowed for certain Class II devices on the exemption list.
- China-specific registration (NMPA Marketing Authorisation): Foreign manufacturers must register through an appointed Overseas Agent (ε’ε€ζ³¨ε代ηδΊΊ) registered with NMPA.
- Unique Device Identification (UDI): Mandatory for Class III devices, phased to Class II.
- Enhanced post-market surveillance: Annual post-market study reports for Class III; strengthened adverse event reporting obligations.
π Effective / published: 1 June 2021
Foreign manufacturers must appoint an Overseas Agent (not merely a distributor) who takes joint regulatory responsibility and is registered with NMPA. Clinical data generated outside China may be accepted subject to NMPA guidelines on overseas clinical data β assess acceptability early in your submission strategy.
View official source (NMPA β Medical Devices) β