"Home-use medical devices now account for one-third of the entire medical device sector. The prevailing concept of chronic disease management has fueled the growth of home medical devices," 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) at a media briefing hosted by a home medical device enterprise on June 24. She stated that the supervision model for home medical devices in recent years has shifted from "focusing on product approval" to "focusing on in-process supervision" throughout the whole lifecycle.

Home-use medical devices refer to devices intended for household use, such as electronic sphygmomanometers, blood glucose meters, ventilators and oxygen concentrators. China currently implements classified management for medical devices. Class I covers low-risk products like cotton swabs and bandages; Class II includes medium-risk products such as electronic sphygmomanometers and electrocardiographs; Class III consists of high-risk products including cardiac pacemakers and vascular stents.

"China’s current medical device supervision framework draws heavily on the regulatory experience of the United States and the European Union," said Xu Shan. Like most countries, China adopts classified management of medical devices, combining pre-market approval and post-market surveillance to realize the transition from approval-centric supervision to process-centric supervision.

Notably, overseas jurisdictions apply different regulatory rules for home-use and non-home-use medical devices. The US FDA categorizes medical devices into prescription medical devices and OTC medical devices, with separate review and supervision protocols for each category.

At present, China does not distinguish regulatory requirements between home-use and non-home-use medical devices. "With the development and popularization of home medical devices, the National Medical Products Administration has started to strengthen and clarify regulatory requirements specific to home-use medical devices," Xu Shan explained. In the 2019 work plan for drafting technical review guidelines for medical device registration issued by the Center for Medical Device Evaluation (CMDE), two to three registration technical review guidelines were directly or indirectly related to home medical devices.

The medical device recall system is a core component of post-market supervision. According to the Annual National Medical Device Adverse Event Monitoring Report released by the National Medical Products Administration, the number of adverse event monitoring reports in China exceeded 370,000 in 2017. "More enterprises are proactively identifying and reporting product issues, which reflects improved awareness and capacity for risk management across the medical device industry," Xu Shan commented.

The Paper checked medical device recall announcements published on the official website of the NMPA and found that 41 product recalls were issued by medical device manufacturers in May alone, most of which were voluntary recalls initiated by enterprises. Recalls of home-use medical devices accounted for a relatively small share, while most recalled products were Class III medical devices.

"This may also relate to the monitoring system, since hospitals regularly submit reports on medical device adverse events," Xu Shan told The Paper. In contrast, most home medical devices are auxiliary diagnostic products, relying mainly on voluntary reporting by manufacturers or feedback from end users when incidents occur. The majority of home-use medical devices are Class II auxiliary diagnostic devices. Enterprises should exercise self-discipline and tighten quality control. They must take the initiative to report quality defects once detected, instead of waiting passively for complaints from users."