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 (also known as the Order 650) and the Medical Device Registration Rules (MDRR) became effective, an applicant submitting a device license application must provide...
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