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Radar des dispositifs médicaux chinois et mondial
Chinese GMP is equivalent to ISO 13485 but with Chinese accent of factory, PTR, quality control and outsouced critical process.
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.
Chinese authority expands inspection of medical device, IVD and drug overseas
Let`s approach Taiwan registration of medical device, one of the strongest Asian sales markets.
The important law in Taiwan for medical device is medical device act which is foundation of product registration.
Regulations on supervision and administration of Medical Device in China is equivalent to EU MDR.
We analyse importance of Chinese IFU of medical device and IVD which overseas manufacturers should take account into. We could support eIFU in China too.