China's medical device industry is in a period of transformation and rapid development. People's requirements for medical care are gradually rising, which is transforming into a huge demand for medical devices. The huge market potential and various policy supports have promoted the rapid growth of China's medical device industry from small to large. The product categories are constantly complete and the innovation ability is constantly enhanced. Leading enterprises have emerged in some subdivided industries. What cannot be ignored is that the phenomenon of small, large, scattered and low-level competition among medical device enterprises in China has not been fundamentally transformed. It is imperative to accelerate technological innovation capability and strengthen scientific supervision.
2022 National Medical Device Supervision Meeting will be held
Recently, according to the official website of the State Food and Drug Administration, the 2022 National Conference on the Supervision and Management of Medical Devices was held in Beijing. The meeting deployed the key work of medical device registration management and medical device supervision in 2022, releasing multiple signals of the medical device industry.
Signal 1: The review and approval of innovative products will be accelerated
The meeting made it clear that in 2022, we should fully implement the electronic review and approval of medical devices and accelerate the review and approval of innovative products; We carried out the "online clearing and offline standardization" of medical devices, and increased the random inspection of medical devices for epidemic prevention and control.
Xu Jinghe, member of the Party Leadership Group and Deputy Director of the State Drug Administration, pointed out that at present, China's medical device industry has entered a "golden development period", the reform and innovation of the review and approval system has entered a "deep promotion period", the construction of regulatory capacity has entered a "comprehensive strengthening period", and the quality supervision has entered a "high risk period".
Xu Jinghe proposed five requirements for the supervision of medical devices: in-depth investigation and rectification of potential risks; Continue to strengthen the supervision of epidemic prevention equipment; Continuously deepen the reform of the review and approval system; Comprehensively promote the implementation of risk management responsibilities; Make every effort to strengthen infrastructure.
The meeting made it clear that we will fully support the high-quality innovative development of the medical device industry in 2022. Accelerate the review and approval of innovative products, promote the transformation and application of scientific and technological achievements, implement major national strategies, and support industrial development in key regions.
In September last year, the General Office of the State Council issued the "Fourteenth Five Year Plan" for Medical Security for All (hereinafter referred to as the "Medical Security Plan"), which proposed to improve the supply and security of medical products. We will deepen the reform of the review and approval system, encourage innovative development of drugs, speed up the listing of new and good drugs, and promote the research and development of new drugs and medical devices that are urgently needed by the people.
The State Food and Drug Administration pointed out in the 2021 medical device report that in 2021, the State Food and Drug Administration will continue to do a good job in reviewing relevant products in accordance with the Special Examination Procedures for Innovative Medical Devices and the Priority Examination and Approval Procedures for Medical Devices. A total of 249 applications for special examination and approval of innovative medical devices were received, an increase of 26.4% over 2020, of which 62 were approved to enter the special examination procedures, and 41 received priority applications, an increase of 46.3% over 2020, 14 of them were approved with priority.
Beijing, Shanghai, Guangdong, Jiangsu and Zhejiang have the largest number of approved products and corresponding enterprises of innovative medical devices, accounting for 81% of the 134 approved innovative medical devices.
Signal 2: Fully implement the registrar system
For conference expenditure, the reform of medical device review and approval system will be promoted in depth in 2022. Fully implement the registrar system, promote the research and transformation of laws and regulations, and fully implement the electronic review and approval.
Continue to strengthen the basic capacity building of medical device registration. Continue to implement the standard improvement plan, continue to improve the medical device standard system, strengthen the classification, naming and coding work, strengthen the publicity and implementation of laws and regulations, vigorously carry out scientific research on supervision, and strengthen international exchanges and cooperation.
Continuously improve the management level of medical device registration. Standardize the local registration and filing business, improve the linkage mechanism of review and approval, improve the management of the National Bureau of Organic Examination Center, strengthen the management of clinical trial institutions and test projects, and severely punish illegal acts.
The coding work is the key work of medical standardization of medical instrument industry management. The coding of medical devices has had a profound impact on many aspects of the industry. According to Cybertron's observation, the first 15 demonstration units of unique identification of medical devices have been released, including registrants, manufacturers and operators. A nationwide situation has been formed in which points lead to areas and areas are expanded.
On January 29, the State Food and Drug Administration issued the Notice on Further Improving the Demonstration and Promotion of the Unique Identification of Medical Devices, pointing out that the unique identification system of medical devices is an important project to implement the Regulations on the Supervision and Administration of Medical Devices, which is conducive to promoting the supervision of medical devices and strengthening the fine management of the whole life cycle.
Chen Shengzhi, who works in the Equipment Department of Zhejiang Third Class A Hospital, said to Cybertron that coding can manage the information and security of medical consumables. The more detailed the content involved, the more efficient it will be. Since the State Food and Drug Administration launched the medical device coding in 2019, the hospital building system has been rapidly established and has begun to take shape.
Signal 3: Carry out investigation and rectification of potential risks
It was proposed at the meeting that in 2022, in-depth investigation and rectification of potential risks should be carried out. Focus on key products, key enterprises and key links, carry out in-depth risk troubleshooting, and conduct regular risk consultation; Carry out the governance of "online clearing and offline standardization" of medical devices, and increase the monitoring of online sales.
Continue to strengthen the supervision of medical devices for epidemic prevention and control. We will strengthen supervision over the production, operation and use of medical devices for epidemic prevention and control, and increase the random inspection of medical devices for epidemic prevention and control.
Continuously strengthen supervision, inspection, inspection, monitoring and evaluation. Continuously carry out flight inspection, strengthen quality supervision and spot check, and strengthen adverse event monitoring. We will continue to strengthen the investigation and punishment of illegal cases, and severely punish illegal medical devices.
We will continue to strengthen regulatory capacity building. We will improve the legal system of medical devices, strengthen the publicity and training of laws and regulations, strengthen the construction of inspectors and information systems, strengthen scientific research on supervision, and promote social co governance.
The Notice on Printing and Distributing the Fourteenth Five Year Plan for the Development of the Pharmaceutical Industry issued by nine national departments not long ago proposed that it would improve the quality management level and product quality throughout the life cycle of drugs and medical devices, promote the high-end, intelligent and green development of the pharmaceutical industry, promote the integration of the Internet, big data, blockchain, artificial intelligence and other new generation information technologies and manufacturing systems, and improve the quality, efficiency and core competitiveness of the entire industry.
Accelerate the quality upgrading of medical devices and improve the stability and reliability of products. Strengthen the construction of quality brands and develop a batch of brand products in the subdivided fields.
Strengthen the quality awareness of enterprises, promote enterprises to strengthen the construction of the quality system under the listing license holder system, and implement the main responsibility for quality throughout the product life cycle. Strengthen enterprise self-management, strictly implement the quality management specifications for R&D, production and operation, improve the quality measurement and risk assessment system, accelerate the establishment of systems for post market research, product traceability, adverse reaction (event) monitoring report, etc., to ensure that the quality of the whole process is controllable.
In terms of laws and regulations, we will strengthen the construction of the regulatory system and accelerate the formulation and revision of supporting rules and regulations in accordance with the Drug Administration Law, the Vaccine Administration Law and the Regulations on the Supervision and Administration of Medical Devices.