According to the NMPA’s (National Medical Products Administration’s) announcement released on September 18, overseas manufacturers of class II and III medical devices and IVDs can establish a foreign-owned enterprise and set up a local production site in China by fulfilling the requirements highlighted in the following:
- The class II or III overseas medical devices and IVDs are already in the market and registered in China
- The applicant’s information of the new registration (foreign-owned enterprise) must be the same with the original registration (importing device), except for the name, address, and factory address of the applicant
- Applicants should refer to the dossier requirements of medical devices and IVDs in China for the registration process
- Successfully registered foreign-owned enterprises must indicate the registration number of the importing device (from the original registration) in the new registration certificate
By Jacky Li. Contact Cisema if you would like to learn more.