Author: cmd@fanzappy.com

The latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in October 2023. These updates are presented by China Med Device, LLC, your partner in Chinese market access.

The NMPA issued an inspection result on October 25, 2023, for the inconsistence of manufacturing addresses. NMPA organized a remote inspection of XVIVO Perfusion AB, a Swedish medical technology company. The inspection focused on their lung perfusion system (XVIVO Perfusion System), a Class III device. It was approved in August 2023.

Hainan government issued the “Administrative Measures of Clinically Urgent Imported Drugs and Medical Devices Taken Out of the Hospital in Hainan Free Trade Port Boao Lecheng International Medical Tourism Pilot Zone” on October 12, 2023. It says that the oral, topical, and subcutaneous injections of drugs and devices can be taken out when patients leave the hospital.

NMPA issued the notice “Soliciting Feedback of Guideline on Medical Device Human Factors Design for the Second Time” on October 11, 2023, after the first round released in May 2020. The feedback needs to be submitted by October 30, 2023. This proposed guideline applies to the human factors design and usability engineering of Class II and III medical devices but does not apply to in vitro diagnostic reagents. It refers to international regulations such as FDA’s “Applying Human Factors and Usability Engineering to Medical Devices” and “List of Highest Priority Devices for Human Factors Review”, etc.