China Confirms Second Batch Of Device Clinical Trial Exemptions
Chinese regulators have added another 359 medical devices to the list of those not needing to undergo clinical investigation in China following feedback from the industry. This second batch of exemptions follows the initial list issued at the end of 2014.
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China has proposed expanding its list of IVDs and medical devices that are exempted from the requirement to undergo local clinical trials. The proposal, when finalized, may speed up the registration of affected products by several months. With respect to ongoing trials, manufacturers will have to decide whether they want to continue with these.
An end-of-year flurry of regulatory activity in the Asian medtech markets has kept industry on its toes, with initiatives in China, Taiwan and Korea, among other regions. But as Asia Regulatory Professional Association (ARPA) Secretary Jack Wong and ARQon consultant May Ng observe in this December update for Medtech Insight, governments and companies in certain markets might benefit from a little more pressure in view of the regulatory tasks they face.
China's Food and Drug Administration is inviting feedback on a new batch of medium- and high-risk medical devices that it intends to exempt from having to undergo local clinical trials. The agency's proposal, if adopted, would make it much easier and less costly for companies that want to place these devices on the Chinese market.