New China NMPA Reform titled “Regulation on the Supervision and Administration of Medical Devices”, or Order 739, long-awaited overarching policy, is finally released. It was adopted by the China State Council on December 22, 2020 and signed into law on March 16, 2021, with the effective date of June 1, 2021.
Compared with Order 680 released in May 2017, Order 739 formalized the responsibilities and accountabilities of Market Authorization Holders (MAHs) for the complete product life cycle, balancing clinical needs and risks, encouraging innovations, and imposing heavier penalties on violations for both companies and companies’ key individuals.
For an English copy of order 739, “Regulation on the Supervision and Administration of Medical Devices” please email info@ChinaMedDevice.com.
Below some of the key highlights:
- MAHs bear the responsibilities for the safety and efficacy of the devices during the entire lifecycle, from R&D, manufacturing, supplying and to final usage.
Balancing Clinical Needs and Risks, Adding More Ways for Market Entry
- Conditional approvals: treating rare, critical diseases without effective treatment or responding to abrupt public health incidents
- The following duties are specified for MAH: solid quality management system, complete post-approval study and risk control plan, robust adverse event monitoring and re-evaluation system, and timely product tracing and recall system
Versatile Clinical Evidence to Support Clinical Evaluation
- Non-clinical trial data before choosing clinical trial
Improve Clinical Trial Management
- Not all the medical device without predicates need to conduct clinical trial
- Hospitals are encouraged to develop and strengthen clinical trial program, as part of their classification and ranking
- Only high-risk Class III medical devices need clinical trial approval
Clinical Trial Compassion Expansion
- Used for other un-enrolled patients with the same condition. Data can be used for registration application
- Priority review with dedicated reviewer and guidance throughout the registration process.
- MAH’s penalties for violations are increased significantly. The manufacturers and distributors can face fines in the range of 15-30 times the sales value (as opposed to 10-20 times the sales value under order 680) to use unapproved devices
- The manufacture and distribution of medical devices that do not conform to mandatory standards or NMPA-approved product technical requirements could result in fines in the range of 5-20 times the sales value (as opposed to 5-10 times the sales value under order 680).
For an English copy of Order 739, “Regulation on the Supervision and Administration of Medical Devices” please email info@ChinaMedDevice.com.