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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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.
The connection between supplier controls and business risks is becoming increasingly evident. In this article, we discuss perspectives on how to maintain a compliant medical device supply chain.
Brazil aligns medical device regulations with global standards, including Europe and the US. Recent updates and international compatibility attract manufacturers.