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Shanghai Life Sciences Partner Authors Law360 Article on China’s New Medical Device Regulation Draft Amendment

Practices: Life Sciences, China Life Sciences, Asia Pacific

Life sciences partner Katherine Wang (Shanghai) authored a July 23 article in Law360 analyzing China’s new medical device regulation (MDR) draft amendment.

Ms. Wang explains that the draft amendment introduces such changes as simplifying the clinical evidence requirements of MDRs by reducing additional clinical studies in China that could accelerate time to market for products with low to moderate risks, reinforce post-approval compliance obligations, and increase fines for non-compliance. The amendment would also permit medical technology companies to use self-test reports to provide conformity to product technology requirements potentially saving time to market, and encourage R&D focused companies to seek regulatory approvals of their products.

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