Radar des dispositifs médicaux chinois et mondial

China Medical Device GMP 2025 (Order No. 107), covering full lifecycle quality management, production, validation, and compliance of medical device.

Explore law of drug in CHina. There is supporting guidances. Contact us for your business of drug in China.

The quality of reply f supplementary questions by Chinese authority matters. It is finding for medical device which manufacturer not only corrects, but also learns.

Production in China + approved imported medical device = Fast track at review and approval

The regulation of medical device including IVD is arising. We make it transparent and simple to understand. Share your ideas with top 10 news. We can develop country strategy with you.

Either for regulatory affairs (registration) in China or beyond, if you have a solid Excel or Word file with tracing items (e.g. PTR), have a free meeting with us. We will make a GRTIS matrix in customer project. You decide the next step and success at Chinese registration

Standards are bridges to conform to essential principle of medical device and to development product. Chinese standards are aligning closer and faster to international standards with national focus.

We explain the possibility of clinical evaluation of highest class III medical device in China.

Learning new country specific regulation in another language is perhaps always a hurdle. Don`t worry. We try to establish a platform where you can learn all regulation by yourself. The registered elearning encloses the video, test, script, meetup with trainer. You will be a giant of regulatory affairs of medical device and In Vitro Diagnostics (IVD) after the course.