The Chinese State Council has passed new Regulation for Medical Device Administration and Supervision (State Council Order 739) to replace the Medical Device Regulations Order 680. 2018 version. Order 739 and has become effective since June 1st, 2021, under the governance of Chinese health authority National Medical Products Administration (NMPA).
The structure of new Order 739 largely follows the old Order 680. However, there are several key changes in the underlying governing thinking and positions. Highlights of the changes are from four aspects. The 1st change is encouraging the innovation. Several new added sections under order 739 promote innovation aggressively. It lifts the home-country approval pre-requisite for innovative devices, which make the global launch possible for novel product manufacturers. Fast track approval routes accelerate the devices’ market placement if they have advanced technology, or are under urgent clinical needs, or are eligible for public-health emergency use authorization (EUA). Conditional approvals are made available for devices treating rare diseases, critical life-threatening diseases that do not have effective treatment or EUA. Medical institutions are allowed to import Class 2 or Class 3 medical devices in small quantities with a special import permit from NMPA-authorized local provincial MPAs to meet urgent clinical needs. Market authorization holder (MAH) scheme will be further promoted from trial provinces to nationwide. 1054 products have been approved under MAH since the trial starts from 2018 in Shanghai and then expanded to additional 22 provinces. Contract product design, development and manufacturing provide more flexible customized outsourcing options to manufacturers and allow research originated institute license holder to focus more on R&D.
The 2nd change is to emphasize the administration through the devices’ life cycle instead of focusing on only pre-market phase. The legal manufacturer is responsible for the safety and effectiveness of their products during the entire product life cycle. NMPA take more measures to monitor the product’s performance after being placed into the market, such as annual periodic risk evaluation report, adverse event monitoring system, recall, and more frequent random quality inspection. The manufacturers shall establish quality management system and ensure its effective operation, define and implement post-market surveillance and risk control plan, conduct active adverse event monitoring and re-evaluation, establish and implement the product tracing and recall system. Third party subcontractors could be involved; however, it is the legal manufacturer, who is responsible for the product in the end.
The 3rd change is to reform the clinical requirements to balance the risk/benefit justification. Order 739 allow broader clinical evidence to demonstrate product safety and effectiveness. Such evaluation can be based on clinical investigational study data or analysis of clinical literature and clinical data from predicate device and reference device(s), and/or from non-clinical data. The products based on mature technology and indication for use, it is most likely to complete the evaluation through literature analysis and predicate device. Only the device with new technology and non-clinical and clinical data are insufficient to prove its safety and performance may require clinical trial. It also mentions that clinical evaluation shall be continuously throughout the entire life cycle of the device. After the product is placed into the market, periodic clinical evaluations are required. A series of clinical evaluation guidance is under commenting stage, such as clinical evaluation technical guideline, demonstration of comparable devices guideline, decision support on if clinical investigational study is needed, clinical evaluation reports supporting registration, and exemption catalogue of clinical evaluation report etc.
The 4th change is to increase the penalties. The manufacture and distribution of unapproved medical devices can lead to financial fine of 15-30 times of the sales revenue (comparing to 10-20 times the sales value under Order 680). The manufacture and distribution of medical devices that do not conform to mandatory standards or NMPA-approved product technical requirements could result in fines of 5-20 times the sales revenue (comparing to 5-10 times the sales value under Order 680). The research institute and medical institutes would also be fined and banned from its activities up for 10 years if breached the regulations. In addition, the products would be banned of importing for 10 years. Order 739 also impose personal liability onto individual staff, such as legal representatives, main responsible persons, directly responsible supervisors, or other personnel involved in MAHs. The income earned of these individuals during the period of non-compliance would be confiscated, plus fine up to 3 times of their income and a permanent prohibition from working and engaging in the manufacturing or distribution of medical devices under serious circumstances.