On June 25, China State Council released a draft amendment to overhaul the medical device regulations. On June 27, Grace Palma, CEO of China Med Device, is interviewed by Zachary Brennan, Managing Editor of Regulatory Focus, from Regulatory Affairs Professionals Society (RAPS).
China Makes Changes to Device Regulations
Posted 27 June 2018 | By
China’s State Drug Administration (SDA, formerly known as the CFDA) announced yesterday that for the first time since 2014, a major overhaul of its medical device regulations has taken root.
“It is timely in that U.S. tariffs are anticipated to be levied at 25% duty on many of the medical devices shipped from China to the U.S.,” consultants from China Med Device wrote.
China Med Device CEO Grace Fu explained to Focus that this is a draft document and interested persons can submit feedback by 24 July. The final version should be coming before the year’s end, she said.
According to the device consultancy, 12 articles were newly added to the regulations, two were deleted and 39 modified.
Among the major changes include allowing the registration holder to be independent of the manufacturer and relaxing the requirements on accepting overseas clinical trial data. Certain devices will also be able to win conditional approval to expedite their entry to the market.
In addition, class II domestic device approvals have been moved from the provincial regulators to the national one. And according to Chinese consultants from Med Device, provincial and local regulators “will establish career inspectors like the regional FDA inspectors in the U.S.”
Fu added that this is a “huge” change as CFDA did not have career inspectors prior to the drafting of these new regulations. She also said there will be more postmarket studies conducted in China and more contract manufacturers.
Text (in Chinese)
Updated with comment from Grace Fu.