Medical Devices

Clinical trials of sodium hyaluronate complex solution have a set of draft guidelines issued by the China CMDE on May 17, 2023.

China registration of ophthalmic optical measurement devices shall refer to the respective technical review guidelines issued by the CMDE

Pre-communication for Hainan medical device clinical RWD applications will be required to follow the CMDE trial measures.

Guidelines for medical device registration in China have new development plans released in April 2023 - 108 will be implemented and revised

China medical device market eRPS data error correction matters will be incorporated into the business scope on April 20, 2023.

China medical device sampling inspection plan for 2023 covers 68 products including electronic endoscopes, medical oxygen concentrators etc.

China radio frequency beauty devices have new technical review guidelines issued to ensure that products are safe and effective

China’s NMPA issues further explanations on how to interpret and implement GB9706.1-2020 standards for medical electrical equipment

China releases a whitepaper on its AI medical device market. The AI medical device industry is becoming a new growth driver.

Ultrasound soft tissue surgical equipment in China have new technical review guidelines amended for registration dossier preparation

China medical device industry standards March 2023 update covers 20 standards released by the NMPA for manufacturers to comply with.

Hong Kong drug and medical device registrations are increasingly in demand. ​​​​​​​Join the Cisema team for a recap of latest policy updates.