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.
To find out more on how Pure Global can assist in navigating the latest rules and regulation in the Medical Devices Industry, contact our sales team today!
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Explore our collection of articles, success stories, and regulatory updates, designed to help you take your product global.
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As 2024 comes to a close, Pure Global proudly reflects on a transformative year marked by substantial growth, cutting-edge innovation, and impactful collaborations.
IVD manufacturers cite the new classification system, detailed definitions for intended purposes, and the need for verification of clinical evidence as key challenges under the IVDR.
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On October 23, the European Parliament adopted a resolution revising specific elements of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Devices Regulation (IVDR). This resolution intends to address ongoing challenges in implementing the regulations by 2025 and to improve patient access to important medical products.
Multilingual documentation presents ongoing compliance and logistical hurdles for MedTech manufacturers. Transla.Ai is an industry-specific translation tool that can accelerate and streamline the translation process.