New China FDA Guidance May Speed Up Device Approvals

Law360, New York (June 17, 2015, 10:21 AM EDT) -- On May 19, 2015, the China Food and Drug Administration unveiled the Technical Guideline Governing Medical Device Clinical Evaluation. The long-awaited guideline explains the methodology and principles for clinical evaluation regarding (i) devices exempted from clinical studies and (ii) devices that may be eligible for a clinical study waiver. More importantly, the guideline clarifies that imported devices can waive in-country study under certain circumstances.

Since 2014’s revisions to Regulations on the Supervision and Administration of Medical Devices[1] (also known as the Order 650) and the Medical Device Registration Rules[2] (MDRR) became effective, an applicant submitting a device license application must provide...

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