New Approval Process for Medical Device Clinical Trials

On 01.04.2019, the NMPA (National Medical Products Administration – former NMPA) announced a change in the clinical trial approval process for medical devices (NMPA No. 2019-26). If the applicant has not received any feedback within 60 working days from the date of clinical trial approval application, clinical trials can be carried out. Instead of an approval notification, the NMPA’s website will display the approval number, the applicant’s name and address, as well as the name, the model specification, structure and composition of the medical device.