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Industry association: household accounts for 1/3 of medical devices, and the emphasis is shifting from approval to process supervision

Source: Time:2019-10-18 13:01:49 浏览次数:

"Home medical devices now account for a third of the total medical device industry, and the prominent concept of chronic disease management has led to the growth of home medical devices. director of the project management office Xu Shan on surging news

"Home medical devices now account for a third of the total medical device industry, and the prominent concept of chronic disease management has led to the growth of home medical devices." On June 24th, in a home medical equipment company held a media communication during the meeting, secretary general of the China association for medical devices industry, national medical equipment industry technology innovation strategic alliance, director of the project management office Xu Shan on surging news (www.thepaper.cn), said in recent years household medical equipment has realized from the "heavy product approval" to "the process regulation" regulation in the whole process of the model.

Alleged family medical appliance, point to the medical appliance that electronic sphygmomanometer, glucometer, ventilator, oxygen machine can be used in the family namely. At present, China implements classified management on medical devices. The first category is products with low risk, such as cotton swabs and bandages. The second category is products with moderate risk, such as electronic blood pressure monitor, electrocardiogram machine, etc. The third category is products with higher risk, such as pacemakers and stents.

"China's current regulatory model for medical devices is largely based on the regulatory experience of the United States and the European Union." Xu shan said that China, like most countries, has implemented classified management of medical devices, and has both pre-listing approval and post-listing supervision to complete the transition from heavy approval to heavy supervision.

It is worth mentioning that the regulation of domestic medical devices in foreign countries is different from that of non-domestic medical devices. The U.S. FDA regulates Preion medical devices and OTC medical devices2 medical devices, and reviews and regulates them according to different categories.

Currently, the regulation of domestic medical devices in China is not differentiated from that of non-domestic medical devices. "With the development and popularization of household medical devices, the national drug regulatory agency has started to strengthen and clarify the regulatory requirements on household medical devices." Xu shan introduced that in the preparation plan of medical device registration technology review guidelines prepared by medical device technology review center in 2019, 2-3 registration technology review guidelines are directly or indirectly related to household medical devices.

The product recall management system is an important part of the national supervision of medical devices after they are put on the market. China had more than 370,000 adverse event monitoring reports in 2017, according to the national medical device adverse event monitoring annual report released by the state drug administration. "The fact that more companies are proactively identifying and reporting product problems represents an increase in the awareness and level of risk management across the medical device industry." Xu shan said.

According to the data of medical device recall announcements published on the official website of the national food and drug administration by thepaper.cn, 41 medical device companies recalled their products in May alone, almost all of them voluntarily. Among them, recall information of household medical devices is relatively low, and most of them are three types of medical devices.

"It may also be related to monitoring systems, as hospitals regularly report adverse events on medical devices." Xu shan told thepaper.cn that most medical devices for home use are diagnostic products and rely on companies to report problems or users to provide feedback. The majority of household medical devices are diagnosed with secondary medical devices. Enterprises should strengthen quality control with self-discipline. If quality problems are found, they should report them actively, instead of waiting for the feedback of users.