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Regulatory Oversight › Medical Devices › China

Ropes & Gray LLP

2025 Medtech Regulatory Affairs Roundtable: Key Takeaways

Ropes & Gray LLP on

On May 22, Ropes & Gray and McKinsey & Company co-hosted the 12th Medtech Regulatory Affairs Roundtable online. Around 40 Regulatory Affairs leaders from Chinese and multinational medtech companies gathered to review and...more

Knobbe Martens

FDA Accuses Third Party Testing Labs of Falsifying Data

Knobbe Martens on

The Food and Drug Administration (FDA) recently issued General Correspondence Letters to two third-party nonclinical testing laboratories. The FDA cited the laboratories “after discovering data that was falsified or otherwise...more

Morgan Lewis

China Amends Regulation Governing Medical Devices

Morgan Lewis on

China recently amended its primary regulation governing medical devices, the Regulation on Supervision and Administration of Medical Devices (2021 RSAMD), which will replace its previous 2014 version and become effective on...more

Hogan Lovells

Major IP reforms foreshadowed in China’s Pharma sector

Hogan Lovells on

On 12 May 2017, the Chinese Food and Drug Administration (the “CFDA”) issued several draft policies aimed at overhauling of the current regulations governing the Chinese pharma and medical device sector (the “Draft...more

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