China: To expand medical device registration pilot to cover multiple regions

07-08-2019

China: To expand medical device registration pilot to cover multiple regions

(Source: RAPS 2019-08-08)

China’s National Medical Products Administration (NMPA) has expanded a medical device registration pilot project. The pilot project, which began in a free trade zone, will now cover 21 provinces to help NMPA accrue more experience of the medical device registration system.

NMPA is running the program as part of its efforts to establish an advanced medical device industry in China. The expectation is that the pilot will improve the use of resources in the device industry by facilitating effective outsourcing, while increasing the use of quality management systems.

To participate in the pilot, a medical device company must have operations in one of the provinces and possess certain capabilities. NMPA wants applicants to have full-time staff experienced in fields such as regulatory affairs and post-marketing oversight, a quality management system and ability to take responsibility for the quality and safety of medical devices.

These capabilities are required as participants in the pilot are expected to strengthen oversight of the facilities that manufacture their devices and increase their monitoring of adverse events. Ultimately, NMPA wants the whole device lifecycle, from R&D to materiovigilance, to be traced and monitored.

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