The State Food and Drug Administration held a meeting to release three major signals for the medical device industry

China's medical device industry is in a period of transformation and rapid development
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People's requirements for medical care are gradually increasing, which is transforming into a huge demand for medical devices

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 changed.
Accelerating technological innovation capabilities and strengthening scientific supervision are the top priorities
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The 2022 National Medical Device Supervision Conference will be held

The 2022 National Medical Device Supervision Conference will be held

Recently, according to the official website of the State Food and Drug Administration, the 2022 National Medical Device Supervision and Administration Work Conference was held in Beijing
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The meeting deployed the key work of medical device registration management and medical device supervision in 2022, releasing a number of medical device industry signals

▍Signal 1: The review and approval of innovative products will be accelerated

▍Signal 1: The review and approval of innovative products will be accelerated

The meeting clarified that in 2022, the electronic review and approval of medical devices will be fully implemented, and the review and approval of innovative products will be accelerated
;

Xu Jinghe put forward five requirements for the supervision of medical devices: carry out in-depth investigation and rectification of potential risks; continue to strengthen the supervision of epidemic prevention equipment; continue to deepen the reform of the review and approval system; comprehensively promote the implementation of risk management responsibilities; go all out to strengthen infrastructure
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The meeting made it clear that in 2022, we will fully support the high-quality innovation and development of the medical device industry
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Accelerate the review and approval of innovative products, promote the transformation and application of scientific and technological achievements, implement major national strategies, and support the development of industries in key regions

The "14th Five-Year Plan" (hereinafter referred to as the "Medical Security Plan") issued by the General Office of the State Council in September last year proposed to improve the supply and safety of pharmaceutical products
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Deepen the reform of the review and approval system, encourage the innovative development of drugs, speed up the launch of new and good drugs, and promote the development and use of new drugs and medical devices that are urgently needed by the masses

In the 2021 medical device report, the State Food and Drug Administration pointed out that in 2021, the State Food and Drug Administration will continue to do a good job in the review of related products in accordance with the "Special Review Procedure for Innovative Medical Devices" and "Priority Approval Procedure for Medical Devices", and received a total of innovative medical devices.

There were 249 applications for special approval of devices, an increase of 26.

Beijing, Shanghai, Guangdong, Jiangsu, and Zhejiang have the largest number of approved products and corresponding companies for innovative medical devices, accounting for about 81% of all the 134 approved innovative medical devices
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▍Signal 2: Fully implement the registrant system

▍Signal 2: Fully implement the registrant system

In 2022, the reform of the medical device review and approval system will be further promoted
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Fully implement the registrant system, promote the research and transformation of laws and regulations, and fully implement electronic review and approval

Continue to strengthen the basic capacity building of medical device registration
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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 regulatory scientific research, and strengthen international exchanges and cooperation

Continuously improve the level of medical device registration management
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Regulate the local registration and filing business, improve the review and approval mechanism, improve the management of the national bureau device review center, strengthen the management of clinical trial institutions and trial projects, and severely punish illegal acts

Coding work is the key work in the management of the medical device industry
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The medical device coding has had a profound impact on many aspects of the industry.
According to the observation of Cyberblue Devices, the first batch of 15 demonstration units of the unique identification of medical devices have been released, including registrants, production enterprises, and operating enterprises
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A nationwide situation has been formed in which the point leads the area and the area expands the area
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On January 29, the State Food and Drug Administration issued the "Notice on Further Doing a Good Job in the Demonstration and Promotion of the Unique Identification of Medical Devices", pointing out that the unique identification system for medical devices is an important project to implement the "Regulations on the Supervision and Administration of Medical Devices", which helps Promote the supervision of medical devices and strengthen the refined management of the whole life cycle
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Chen Shengzhi, who works in the equipment department of Zhejiang's third-class hospital, said to Cyberblue Equipment: Coding can carry out information and safety management of medical consumables.
The more detailed the content involved, the higher the efficiency will be.
After the coding of medical devices, the construction system of the hospital is rapidly established, and it has already begun to scale
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▍Signal 3: Carry out investigation and rectification of hidden dangers

▍Signal 3: Carry out investigation and rectification of hidden dangers

The meeting proposed to carry out in-depth investigation and rectification of hidden dangers in 2022
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Focus on key products, key enterprises and key links, carry out in-depth investigation of potential risks, and conduct regular risk consultations; carry out "online clearing and offline standardization" governance of medical devices, and increase monitoring of online sales
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Continue to strengthen the supervision of medical devices for epidemic prevention and control
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Strengthen the supervision of the production, operation and use of medical devices for epidemic prevention and control, and increase the sampling inspection of medical devices for epidemic prevention and control
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Continuously strengthen supervision, inspection, inspection and monitoring and evaluation
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Continuously carry out unannounced inspections, strengthen quality supervision and random inspections, and strengthen adverse event monitoring
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Continue to increase the investigation and punishment of illegal cases, and severely punish and severely punish violations of laws and regulations of medical devices
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Continue to strengthen supervision capacity building
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Improve the legal system for medical devices, strengthen the publicity and training of regulations, strengthen the construction of inspector teams and information systems, strengthen regulatory scientific research, and promote social co-governance
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Not long ago, the "Notice on Printing and Distributing the "14th Five-Year" Pharmaceutical Industry Development Plan" issued by the nine national departments proposed that it will improve the quality management level and product quality of the whole life cycle of drugs and medical devices, and promote the high-end, intelligent and green pharmaceutical industry.
It promotes the integration of new-generation information technology and manufacturing systems such as the Internet, big data, blockchain, and artificial intelligence, and improves the quality, efficiency and core competitiveness of the entire industry
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Accelerate the quality upgrade of medical devices and improve the stability and reliability of products
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Strengthen quality brand building and develop a number of brand products in subdivided fields
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Strengthen the quality awareness of enterprises, promote enterprises to strengthen the quality system construction under the listing license holder system, and implement the main responsibility for product life cycle quality
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Strengthen enterprise self-management, strictly implement R&D, production, and operation quality management standards, improve quality measurement and risk assessment systems, and speed up the establishment of post-market research, product traceability, adverse reaction (event) monitoring reports and other systems to ensure the entire process quality controllable
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In terms of 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
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