NMPA fosters medical device innovation through regulatory consultations, tailored plans, guidance, updates on approvals, and compliance with MDR, IVDR, and MPDG.
The National Medical Products Administration (NMPA) is committed to promoting high-quality development in medical device innovation through regular regulatory consultations. These consultations involve creating specific regulatory plans, guiding registrants to enhance their quality management systems, and ensuring continuous compliance.
Key Points:
15.07.2024: Application for special approval: Involves instructions published for applying for special approval, indicating a regulatory process or update related to medical device approvals or exemptions.
Involves information on the reporting channels and obligations under the Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR), and the Medical Devices Implementation Act (MPDG).
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