The Chinese National Medical Products Administration (NMPA) has published new data showing a 38% decline in medical device registrations approved by the agency in 2018 compared to 2017 as the government continues efforts to update and improve the country’s regulatory system.

The NMPA report (link in Chinese) notes that a total of 5,528 initial registrations, registration renewals and change registrations were approved by the regulator in 2018, the lowest number of such approvals in five years. (In 2017, Chinese regulators reported nearly 9,000 total registration approvals.) Approval rates fell across nearly all registration categories and for all medical device classifications, according to the report.

Key NMPA report findings:

• More than 40% of registrations approved by NMPA in 2018 were for licensing changes;
• Approvals of Class II medical devices imported from other countries saw a three-percent increase between 2017 and 2018;
• First-time device registrations accounted for 18% of all imported device market applications;
• First-time device registrations made up more than 40% of all Class III applications in 2018;
• Approvals of imported Class III devices decreased more than nine percent from 2017 to 2018.

Factors behind lower registration approval rates

Although the NMPA report does not provide explicit reasons for the decline in registration approvals last year, the Chinese government’s ongoing initiatives (most recently for an electronic registration system and technical review guidelines, for example) to standardize and improve the country’s medical device and IVD regulatory system has resulted in significant changes to how devices are overseen in the country. NMPA may be utilizing more resources to apply regulatory changes to China’s existing medical device and IVD registrants, helping explain lower 2018 approval rates.

Regulatory changes in China also appears to be affecting foreign medical device and IVD manufacturers’ commercialization plans. According to Emergo by UL’s 2019 Global Medical Device Industry Outlook, which surveyed more than 2,300 industry participants, more than 60% of respondents indicated that China’s regulatory approval process has become more difficult over recent years. In addition, the percentage of Emergo by UL survey participants that consider the Chinese market as having strong growth potential fell from 23% in 2018 to 20% in 2019.

Given the depth and breadth of medical device regulatory changes underway in China, a slightly more cautious industry outlook as well as a marked impact on the numbers of NMPA approvals are unsurprising short-term effects.

Learn more about Chinese medical device and IVD regulatory issues at Emergo by UL:

• China NMPA medical device registration and approval consulting
• Certificate of Free Sale (CFS) support for medical device exports
• Whitepaper: China NMPA medical device registration requirements
• Regulatory process chart: China NMPA medical device regulatory approval