Historical changes of medical device industry has been made in China. Amendment of the Regulation on the Supervision and Administration of Medical Devices was adopted by the China State Council on December 22, 2020. It is the finalization of the draft version issued on June 25, 2018. (For RAPS interview with Grace Palma, CEO of China Med Device, on the draft please click HERE)
On the same day, NMPA Yangtze River Delta Sub-center for Drug and Medical Device Evaluation was established in Shanghai. The next day, on December 23, NMPA Big Bay Area Sub-center for Drug and Medical Device Evaluation formed in Shenzhen.
New Trends for Medical Devices
- “Easier access and stricter regulation”. The future approvals of medical devices will encourage innovation, lower the entry threshold, and strengthen supervision and inspection.
- The main purpose of the establishment of the sub-centers is to streamline the approval process and promote the innovation and competitiveness of the medical device industry in the region
- The medical device industry is set for the most stringent regulation in its history, with a dramatic increase in the supervision intensity and frequency, and the cost of penalties
- A series of policies are expected to follow, and there may be more sub-centers in the future
China Med Device suggests manufactures to follow the new requirements to do relevant registration. Compliance and surveillance for medical devices are becoming more and more stringent in China and CMD can help you evaluate the gap between your products and China guidelines or standards.
Amendment of Regulation on the Supervision and Administration of Medical Devices
The Regulation on the Supervision and Administration of Medical Devices is the “constitution” of the industry, and its amendment and adoption are of great significance to medical device development in China..
The amendment of the Regulation will
- emphasize the responsibility of manufacturers and research institutions for the safety and efficacy of medical devices
- clarify the procedures for registration and filing
- enrich the means of supervision, such as the unique device identification (UDI) traceability, the extended inspection scope and other supervisory measures
- increase penalties for illegal acts. The fine for serious violations of laws in quality and safety will be substantially increased (the maximum penalty may be 20 times the value of the goods); the enterprises and persons who are responsible for serious violations will be severely punished, such as license revocation, the industry and marketing prohibition; And criminal responsibility will be investigated in accordance with the law.
On the other side, the regulations will also stimulate the innovation motivation of the industry from the following three aspects:
- Piloting of third-party testing. The manufacture may not need to test their products in the ten designated testing centers anymore, which will greatly accelerate the testing and registration process. Meanwhile, if the test can be carried out in the self-owned qualified laboratories, manufactures may save large amount of money
- Continuous implementation of the legal agent system. For our comments on Guideline for Imported Medical Device Legal Agent (Draft), please click HERE
- Conditional clinical trial and approval. For Guideline on Conditional Approval, please click HERE
Establishing the Two Sub-centers
Although no specific rules have been issued to explain the responsibilities of the two sub-centers, it is estimated that it will mainly play a role in accelerating the review and approval process and increasing the surveillance of medical devices.
In 2019, the total number of registration approvals for the Class II and III medical devices in China reached 25,500 – a 53.6 percent year-on-year rise. The rapid development of the medical device industry has brought great pressure to NMPA which needs to streamline the review process and improve the efficiency..
According to current regulations, the registration of a high-risk Class III medical device in mainland China takes three to four years with human clinical trials. In some cases, it takes more than four or five years. Among them, the regulatory approvalprocess, including the first-round review and supplementary time, is more than one year.
Therefore, the establishment of the two sub-centers can reduce communication costs, provide timely suggestions for modification of existing product problems, provide guidance for manufactures, and jointly discuss relevant technical issues. This may tremendously accelerate the registration process in the future.