National Medical Products Administration Holds Meeting, Sending Three Major Signals to the Medical Device Industry

China’s medical device industry is currently undergoing a period of transformation and rapid growth. As public demand for healthcare continues to rise, it is translating into robust market demand for medical devices. Driven by substantial market potential and supportive government policies, the industry has expanded rapidly from a small-scale sector to a major player, with an increasingly comprehensive product portfolio, strengthening innovation capacity, and the emergence of leading enterprises in several niche segments. However, it remains crucial to recognize that the prevailing characteristics of small size, fragmentation, and low-level competition among Chinese medical device firms have yet to undergo fundamental change; therefore, accelerating technological innovation and enhancing evidence-based regulation have become urgent priorities.

National Medical Device Regulatory Conference Held in 2022

Recently, according to the official website of the National Medical Products Administration, the 2022 National Conference on the Supervision and Administration of Medical Devices was held in Beijing. The conference outlined the key priorities for medical device registration management and regulatory oversight in 2022, sending several important signals to the medical device industry.

Signal 1: The review and approval of innovative products will be expedited.

The meeting affirmed that in 2022, the electronic submission and review of medical device applications will be fully implemented, with accelerated review and approval for innovative products; a campaign to “clean up online platforms and standardize offline operations” for medical devices will be launched, and inspection efforts on medical devices used for epidemic prevention and control will be intensified.

Xu Jinghe, a member of the Party Leadership Group and Deputy Director of the National Medical Products Administration, pointed out that China’s medical device industry has now entered a “golden period of development,” the reform and innovation of the review and approval system have entered a “phase of in-depth advancement,” the building of regulatory capacity has entered a “phase of comprehensive strengthening,” and quality supervision has entered a “phase of high-pressure risk management.”

Xu Jinghe put forward five requirements for the regulation of medical devices: conduct in-depth identification and rectification of risks and hazards; continuously strengthen oversight of medical devices used for epidemic prevention; further deepen reform of the review and approval system; comprehensively ensure that risk-management responsibilities are effectively implemented; and make all-out efforts to strengthen infrastructure.

The meeting affirmed that in 2022, all efforts will be made to fully support the high-quality, innovative development of the medical device industry. This includes accelerating the review and approval of innovative products, promoting the translation and application of scientific and technological achievements, implementing major national strategies, and supporting industrial development in key regions.

In September last year, the General Office of the State Council issued the “14th Five-Year Plan for National Medical Security” (hereinafter referred to as the “Medical Security Plan”), which proposed enhancing the capacity to ensure the supply and safety of pharmaceutical products. The plan calls for deepening reform of the review and approval system, encouraging innovation in drug development, accelerating the market launch of new and high-quality drugs, and promoting the research, development, and use of urgently needed new drugs and medical devices.

In its 2021 Medical Device Report, the National Medical Products Administration (NMPA) stated that, in 2021, it continued to review relevant products in accordance with the Special Review Procedure for Innovative Medical Devices and the Priority Review Procedure for Medical Devices. A total of 249 applications for special approval of innovative medical devices were received, an increase of 26.4% compared with 2020; among these, 62 were approved to enter the special review procedure. Additionally, 41 priority review applications were received, up 46.3% from 2020, with 14 of them granted priority review status.

Beijing, Shanghai, Guangdong, Jiangsu, and Zhejiang account for the largest number of approved innovative medical devices and the corresponding number of enterprises, representing approximately 81% of the total 134 approved innovative medical devices.

Signal No. 2: Full Implementation of the Registration Holder System

Regarding conference expenditures, in 2022 we will deepen the reform of the medical device review and approval system. We will fully implement the registrant system, advance research on and translation of relevant regulations and systems, and comprehensively digitize the review and approval process.

Continuously strengthen the foundational capacity for medical device registration. Continue to implement the Standards Enhancement Program, further refine the medical device standards system, intensify work on classification, nomenclature, and coding, reinforce the dissemination and implementation of relevant regulations, vigorously advance regulatory science research, and enhance international exchange and cooperation.

Continuously enhance the level of medical device registration management. Standardize local registration and filing procedures, improve the coordination mechanism between review and approval processes, refine the management of the National Medical Products Administration’s Center for Medical Device Evaluation, strengthen the oversight of clinical trial institutions and trial projects, and impose strict penalties for illegal activities.

Coding is a key priority in the regulation of the medical device industry. Medical device coding has already had a profound impact on multiple aspects of the industry. According to observations by Cybrary Medical Devices, the first batch of 15 demonstration units for unique identification of medical devices has now been announced, encompassing registrants, manufacturers, and distributors. Nationwide, this initiative is creating a momentum of “starting with pilot sites and expanding across the board.”

On January 29, the National Medical Products Administration issued the “Notice on Further Advancing the Demonstration and Promotion of the Unique Identification System for Medical Devices,” stating that the unique identification system for medical devices is a key initiative for implementing the Regulations on the Supervision and Administration of Medical Devices and that it helps to strengthen medical device regulation and enhance refined, full-lifecycle management.

Chen Shengzhi, who works in the Equipment Department of a Grade-III hospital in Zhejiang Province, told Cybrary Medical Devices: “Coding enables the digital and secure management of medical consumables; the more detailed the information covered, the higher the efficiency. Since the National Medical Products Administration launched the medical device coding system in 2019, hospitals have been rapidly establishing their own systems, which have now reached a preliminary scale.”

Signal Three: Conduct Risk and Hazard Identification and Rectification

The meeting proposed that in 2022, comprehensive efforts should be made to identify and address risks and hazards. Focus should be placed on key products, key enterprises, and critical links in the supply chain, with thorough risk assessments conducted and regular risk consultations held. In addition, a campaign will be launched to regulate medical devices through “online clearance and offline standardization,” with enhanced monitoring of online sales.

Continuously strengthen the regulatory oversight of medical devices used for epidemic prevention and control. Enhance supervision over the production, distribution, and use of such devices, and increase the frequency of random inspections.

Continuously strengthen supervision, inspection, testing, and monitoring and evaluation. Regularly conduct unannounced inspections, intensify quality oversight through random sampling and testing, and enhance adverse event monitoring. Consistently step up enforcement against violations and impose severe penalties for illegal and non-compliant practices involving medical devices.

Continuously strengthen regulatory capacity building. Improve the regulatory framework for medical devices, enhance publicity and training on relevant regulations, reinforce the development of the inspector workforce and information systems, intensify research in regulatory science, and promote collaborative governance involving all sectors of society.

Recently, the State Council’s nine ministries and commissions issued the “Notice on Printing and Distributing the 14th Five-Year Plan for the Development of the Pharmaceutical Industry,” which sets forth the goal of enhancing quality management across the entire lifecycle of pharmaceuticals and medical devices and improving product quality; promoting the high-end, intelligent, and green development of the pharmaceutical industry; fostering the integration of next-generation information technologies—such as the Internet, big data, blockchain, and artificial intelligence—with manufacturing systems; and boosting the industry’s overall quality, efficiency, and core competitiveness.

Accelerate the quality upgrade of medical devices to enhance product stability and reliability. Strengthen brand-building efforts and develop a portfolio of branded products in niche segments.

Strengthen enterprises’ quality awareness, encourage them to enhance their quality management systems under the marketing authorization holder system, and ensure that they assume full responsibility for product quality throughout the entire product lifecycle. Enhance enterprise self-management, rigorously enforce Good Research, Development, Manufacturing, and Marketing Practices, improve quality measurement and risk assessment frameworks, and expedite the establishment of post-marketing studies, product traceability mechanisms, and adverse reaction (event) monitoring and reporting systems, thereby ensuring that quality is controllable across the entire process.

In terms of regulatory oversight, efforts will be intensified to strengthen the development of the regulatory framework and institutional system, with accelerated 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.