The 2023 National Medical Device Supervision and Administration Work Conference was held in Beijing. The meeting summarized the work in 2022 and the past five years, and deployed key tasks for 2023. On the basis of the reforms in 2022, this meeting deployed the key tasks of medical device registration management and supervision in 2023.
Focus 1: Do a good job in approval of key products
In terms of medical device registration management, the meeting pointed out that in 2023, we will continue to review and approve key products, closely follow up on the safety of products on the market, and support the transformation of scientific and technological innovation achievements in key areas.
It is understood that in 2022, the State Food and Drug Administration approved a total of 2,500 registered medical device products for marketing, a year-on-year increase of 46.2%. A total of 13,334 Class II medical device products were approved and registered by various provincial bureaus, a year-on-year increase of 2.2%. Prefectural and municipal bureaus handled 28,508 first-class product registrations, a year-on-year increase of 6.5%.
According to the People’s Daily Health Client, the State Food and Drug Administration announced that 54 Class III innovative devices were approved for marketing in 2022, a significant increase compared with 35 in 2021.
In addition, there will be new breakthroughs in the localization of high-end medical equipment in 2022. The first domestic proton therapy system was approved for sale, the heavy ion therapy system in Wuwei, Gansu was renovated and upgraded, domestic extracorporeal membrane oxygenation products (ECMO) were put into use, and domestic artificial blood vessels and other products that have long relied heavily on imports were approved for sale.
Focus 2: Carry out pilot projects of self-made reagents
The meeting pointed out that we will support regulatory innovation and industrial development in key areas, continue to consolidate the legal basis for registration management, solidly carry out self-made reagent pilots, maintain good order in registration management, strengthen review and approval capacity building, strengthen clinical trial management, and continue to deepen special rectification.
In March 2021, the State Food and Drug Administration issued a new version of the “Regulations on the Supervision and Administration of Medical Devices.” Article 53 mentions: For in vitro diagnostic reagents that do not have the same type of product on the market in China, qualified medical institutions can develop them on their own based on the clinical needs of the unit and use them within the unit under the guidance of licensed physicians. Specific management measures shall be formulated by the drug regulatory department of the State Council in conjunction with the health authority of the State Council.
At present, some regions have begun to promote pilot projects of self-made reagents.
The “14th Five-Year Plan for the Development of Strategic Emerging Industries in Guangzhou” proposes that in the field of medical testing, it will actively support the pilot of laboratory self-built testing methods (LDT), encourage the development of “integrated” platform technology, develop high-end integrated testing and testing equipment, and overcome key technologies such as stability, reliability, miniaturization and intelligence of instruments.
The “Opinions on Supporting the High-level Reform and Opening Up of Pudong New Area to Create a Leading Area for Socialist Modernization” issued by the State Council clearly states that qualified medical institutions are allowed to carry out pilot projects of self-developed in vitro diagnostic reagents in accordance with relevant requirements within the Pudong New Area.
Focus 3: Expand the application scope of UDI in an orderly manner
The meeting pointed out that we should continue to improve the registration management technical support system, further improve the level of classified management, gradually and orderly expand the scope of UDI application, promote medical device scientific research, enhance smart supervision capabilities, and deepen international exchanges and cooperation.
It is understood that two batches of medical device labeling work have been carried out, fully covering the third category of medical devices. On January 1, 2021, the first batch of 69 varieties in 9 categories began to implement medical device labeling. On June 1, 2022, other Class III medical devices (including in vitro diagnostic reagents) will be fully implemented with medical device labeling as the second batch of implemented varieties.
In November 2022, the General Affairs Department of the State Food and Drug Administration publicly solicited opinions on the “Announcement on Implementing the Third Batch of Medical Device Labeling (Draft for Comment)” and determined some disposable products with large clinical demand, varieties included in the scope of medical insurance centralized procurement, medical beauty-related products and other Class II medical devices as the third batch of medical device labeling implementation varieties based on the degree of risk and regulatory needs.
Focus 4: Strengthen unannounced inspections
The meeting pointed out that in terms of medical device supervision and management, focus will be placed on strengthening supervision and inspection and supervision and spot checks in 2023 to serve the overall situation of epidemic prevention and control. We will continue to deepen special rectification, crack down on violations of laws and regulations, and bring into play the role of long-term mechanisms. Strengthen key supervision and strengthen unannounced inspections.
It is understood that the special rectification of medical devices continues to be vigorous. Last year, special rectification of medical devices and special rectification of colored contact lenses and medical beauty products were organized. It focused on key products such as epidemic prevention and control, centralized mass procurement, and key enterprises with entrusted production and bad regulatory credit records, and promoted the investigation and management of hidden dangers in depth. Focusing on high-risk enterprises and products, the National Bureau organized unannounced inspections of 89 enterprises throughout the year to deal with outstanding problems in a timely manner.
Starting from January this year, the “Guiding Opinions on Strengthening the Classified Supervision of Medical Device Production and Operations” issued by the State Food and Drug Administration began to be implemented.
It puts forward the principles and inspection requirements for the classification of supervision levels for medical device production and operation enterprises. The drug regulatory department can divide medical device enterprises into four supervision levels according to risks, and implement corresponding supervision measures for enterprises at different supervision levels.
For enterprises with good regulatory credit status for a long time, the supervision level can be lowered as appropriate; for medical device registrants with cross-regional commissioned production, entrusted production enterprises that only engage in entrusted production, and operating enterprises with additional warehouses in other places, the supervision level should be raised as appropriate.
Supervision and inspection of medical device manufacturers shall be carried out without prior notification, and unannounced supervision and inspection of operating enterprises shall be carried out.
Focus 5: Strengthen supervision of online sales
The meeting pointed out that supervision of online sales should be strengthened and risk discussions should be deepened. Deepen supervision and random inspection work and improve the efficiency of monitoring work. Continuously improve regulatory laws and regulations, optimize and innovate regulatory methods, strengthen the construction of regulatory teams, promote social co-governance, and promote international cooperation.
From January 9 to 11 this year, Xu Jinghe, a member of the Party Leadership Group and Deputy Director of the State Food and Drug Administration, while investigating the supervision of drugs and medical devices for COVID-19 prevention and control in Anhui and Jiangsu, emphasized the need to strengthen the monitoring and disposal of online sales of medical devices and promote the implementation of the main responsibilities of third-party platforms and online sales companies.
It has been observed that last year the State Food and Drug Administration reported cases of illegal sales of medical devices online. In July 2022, the State Food and Drug Administration reported in the “Second Batch of Typical Cases of Special Drug Safety Rectification” that a company purchased motherboards, casings, and packaging from an online platform, produced and operated 46 Class II medical devices “Deafness and Tinnitus Lightwave Instruments” without a license and had not obtained a medical device registration certificate, and sold them through the online platform.
Overall, the current reform of the medical device review and approval system continues to advance in depth. At the same time, greater supervision and optimization and innovation of supervision methods have also created a good environment for the sustainable development of the industry.