Industry Association: Home medical devices account for 1/3 of the market; the regulatory focus is shifting from heavy approval to process oversight.

“Home medical devices now account for one-third of the entire medical device field, and the prominent concept of chronic disease management is driving their growth.”6Month24Day, at a media communication meeting held by a home medical device company, Xu Shan, secretary-general of the China Medical Device Industry Association and project director of the Management Office of the National Medical Device Industry Technology Innovation Strategic Alliance, told The Paper (www.thepaper.cn) that in recent years, home medical devices have transitioned from“emphasis on product approval”to“emphasis on process supervision”a full process supervision model.

So-called home medical devices refer to medical devices that can be used at home, such as electronic sphygmomanometers, blood glucose meters, respirators, and oxygen generators. Currently, China implements a classified management system for medical devices. Class I devices are those with lower risk levels, such as cotton swabs and bandages; Class II devices have moderate risks, such as electronic sphygmomanometers and electrocardiographs; and Class III devices have higher risks, such as pacemakers and vascular stents.

“China's current medical device regulatory model largely draws on the regulatory experience of the United States and the European Union.”Xu Shan stated that, like most countries, China implements classified management of medical devices, with both pre-market approval and post-market supervision, completing the transition from emphasizing approval to emphasizing supervision.

It is worth mentioning that, internationally, the regulation of home medical devices differs from that of non-home medical devices. The U.S.FDAclassifies medical devices intoPreion medical devicesandOTC medical devices2categories for management, with review and supervision conducted according to different categories.

Currently, China does not differentiate between the regulation of home and non-home medical devices.“With the development and popularization of home medical devices, the National Medical Products Administration has begun to strengthen and clarify its regulatory requirements for home medical devices.”Xu Shan introduced that2019the medical device registration technical review guideline compilation plan drafted by the Center for Medical Device Evaluation in the year included2-3registration technical review guidelines directly or indirectly related to home medical devices.

For post-market supervision of medical devices, the product recall management system is an important component of national supervision. According to the National Medical Products Administration's published "Annual Report on the Monitoring of Adverse Events of Medical Devices,"2017year, China's monitoring reports on adverse events exceeded37ten thousand copies.“More companies are proactively discovering and reporting product problems, representing an improvement in risk management awareness and capabilities across the medical device industry.”Xu Shan said.

A search by The Paper on the official website of the National Medical Products Administration for published medical device recall announcements revealed that in5month alone, there were41medical device companies with product recall information, almost all of which were proactive recalls by the companies themselves. Home medical device recall information accounted for a relatively low proportion; the majority were Class III medical devices.

“This may also be related to the monitoring system, as hospitals regularly report information on adverse medical device events.”Xu Shan told The Paper that home medical devices are mostly used for auxiliary diagnosis, primarily relying on companies to proactively report problems or on users providing feedback when issues arise. Home medical devices mainly consist of Class II medical devices for auxiliary diagnosis, and companies should take the initiative to strengthen quality control and proactively report quality issues when detected, rather than simply waiting for users to report problems.