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.
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Learn more about China Medical Device Registration & Approval.
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).
Learn more about EU Medical Device Registration.
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Explore our collection of articles, success stories, and regulatory updates, designed to help you take your product global.
The IVDR transition includes structured processes IVD manufacturers must follow to engage with Notified Bodies. Many IVD manufacturers are interacting with Notified Bodies for the first time and must understand what is required to ensure a successful partnership. In this article, Dr. Oliver Eikenberg clarifies what manufacturers must prepare and when to engage a Notified Body for IVDR CE Marking.
Class D IVD manufacturers face fast-approaching IVDR transition deadlines, though some are more familiar with the regulatory process. In this article, Dr. Oliver Eikenberg discusses the difference between "new" and "old" Class Ds, and regulatory logistics they need to consider during the transition process.
Your IVD's intended purpose determines its classification, clinical evidence requirements, and clinical applications under the IVDR. Device companies will need a more robust intended purpose to fulfill IVDR criteria. In this article, Dr. Oliver Eikenberg explains the role of the intended purpose in IVDR compliance.
