China FDA has unveiled guidelines on medical device clinical trial supervision and management that will take effect in June, marking the latest effort in the field to ensure quality and safety standards for multinational and domestic products.
According to a notice on the China FDA website, the guidelines of 96 articles in 11 chapters cover a gamut of preparation criteria, informed consent, protocols and data management among other areas.
The guidelines were jointly issued with the National Health and Family Planning Commission under a document titled "Medical Device Clinical Practice (GCP)" (Food and Drug Administration of Order No. 25).
A Chinese language version of the order said the details relied on "international standards" borne out of management experience to place patient safety and science at the heart of all trials.
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| Chang-Hong Whitney, president, Whitney Consulting |
Med tech consultant Chang-Hong Whitney was cited this month in an article with FierceMedicalDevices as telling a seminar that China FDA has issued more than 20 guidance documents on medical device regulation over the last two years as part of stepped-up oversight plans.
She noted that all but the simplest Class I devices need to convince the China FDA that there is a predicate device on the market in China, or they must conduct a clinical trial in the country to secure approval, according to the FierceMedicalDevices article.
"The majority of the products we are working with right now are facing the fact that you will have to do a clinical trial in China," Whitney told an audience of med tech stakeholders from industry such as Medtronic ($MDT), as well as startups and med tech consultants.
On the other end of the market, there is also a need for China manufacturers to develop and prove products that can be accepted more widely for export, according to Helen Chen, head of the China life science practice and co-head of the China practice of L.E.K. and colleague Stephen Sunderland.
In an article published in February, the group said a big part of the story of exports of medical devices from China is the growing reach into emerging markets--much of which was driven by acquisitions of Western firms, or vice versa.
- here's the release from China FDA
- and the Chinese language version