An easy Journey of Medical Device Registration (including IVD) in China and global
National Medical Products Administration (NMPA, formerly China Food and Drug Administration, CFDA) is Chinese authority of drugs, medical devices and cosmetics.
*In-vitro Diagnostics Regulation belongs also to regim of NMPA
The path to commercializing a medical device (including IVDs) can seem non-transparent at first, particularly for product registration in China. In reality, the regulation is broadly similar to — and in some areas catching up with — international frameworks such as International Medical Device Regulators Forum (IMDRF), the EU Medical Device Regulation (MDR, 2017/745), the EU In-Vitro Diagnostic Regulation (IVDR) and the U.S. Federal Food, Drug, and Cosmetic Act (FD&C Act)..
Since 2014, Chinese legislation has been evolving rapidly. Regulators are increasingly aligning with international standards and state-of-the-art, product-specific guidance: post-market surveillance (e.g., periodic risk evaluation reports), verification and validation requirements (biocompatibility, clinical evaluation and studies, packaging and shelf-life validation, sterilization validation), and more. In 2019 the NMPA introduced an electronic regulated product submission system (eRPS) to streamline acceptance and technical review and to shorten review times.
We accompany your journey doing exceptional business to and from China by sharing knowledge on medical device regulation and offering premium regulatory-affairs services for global markets.
Product technical requirement, type testing and Chinese labelling are challenging parts of unique features with special Chinese requirements for foreign manufacturer.
Puzzle?
With us you have a reliable guide through the international regulatory jungle of medical device.
Learning & capability building — Build regulatory knowledge and operational skills through structured, practical learning. Our E-Learning courses cover Chinese and international regulatory essentials so your team can master dossier preparation, clinical evidence needs, and post-market obligations at their own pace. Complement learning with focused, hands-on on-demand workshops where we work through real case studies and templates to make compliance immediately actionable.
Project execution & market entry — Turn knowledge into results with dedicated project support and tools. Our
China Project Management service manages NMPA interactions, local tech translations and submission logistics so your registration runs smoothly. Use our
AI PTR change tool to accelerate periodic risk evaluation reporting. For worldwide strategy, our
International registration comparison clarifies differences between EU, US and China routes. We also advise on
MedTech investment in EU & US and provide an
Incubator for the Chinese market to help companies scale operations and partnerships.
Our service
Medical device (IVD) registration
Either filling of class I or registration of class II and III medical device or IVD in China, we are your transparent and premium consulting partner.
Go through our unique articles, up to date blogs and free downloads. You deserve to be a Chinese experte.
E-Learning of regulatory affairs and training
We offer personal E-Learning, face to face meeting, team training, webinar of all personlised topics to optimise your process, to prove workflow and overseas post market activities
Use this plattform to find your valaible partners in China, to publish a regulatory paper, to leverage other international registrations and to monitor business development in China.
Global registration business
It’s a major headache for manufacturers to move a device from MDR to FDA, ANVISA or NMPA — or to take a product from US into the EU and ASEAN. Every market has its own quirks, but the foundation is the same: complete, well-structured technical documentation tailored with country-specific evidence and formats.
Let’s sail global — with full compliance.
