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Asia Regulatory Roundup: China Reports 25% Fall in Initial Medical Device Registrations

China’s National Medicinal Products Administration (NMPA) has reported a 25% year-on-year drop in initial registrations of medical devices. The fall dragged the overall level of registration activity down to its lowest level since China began publishing data on the topic in 2013.


Last year, NMPA approved 1,128 initial medical device registrations. When renewals and changes are factored in, the overall number of registration approvals for the year totals 5,528. In 2017, NMPA approved 1,507 initial registrations and 8,579 filings overall. Since the start of records in 2013, China had never previously approved fewer than 7,530 registrations in a year.


NMPA provided no explanation for the sharp fall in registrations. The trend was driven by declining activity in multiple areas. The number of renewals approved was down 59% on the prior period. There were similarly significant declines in the numbers of approvals of filings to import and register Class III medical devices. Registrations by provincial drug regulatory authorities fell sharply, too.


The number of registration changes approved by NMPA was the exception to the downward trend. NMPA signed off on 21% more changes in 2018 than the previous year, potentially reflecting growth in the number of medical devices already registered for use in China.


Those efforts have continued into 2019. This week, NMPA published technical guidelines on the electronic submission of medical device registration applications and an accompanying document on its electronic declaration information system. NMPA published the documents as part of its work to implement a 2017 government order about the reform of the medical device approval system.






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