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