Major changes in medical device approvals and R&D costs are greatly reduced In China

2019-09-11 17:00

For those who agree to carry out clinical trials, the Approval Center will publish the acceptance number, applicant’s name and domicile, the name of the experimental medical device, model specifications, structure and composition on the Approval Center’s website, and inform the application of the review results through the Approval Center’s website People, no longer issue clinical trial approval documents.




Other requirements for the approval of clinical trials of medical devices shall be implemented in accordance with the "Measures for the Administration of Medical Device Registration" and other relevant regulations.




The "Announcement" stated that the above-mentioned examination and approval procedures have been implemented since the date of issuance, that is, it has been implemented on March 29.




In fact, the day before the "Announcement" was issued (March 28), the State Food and Drug Administration held a medical device innovation development and review and approval reform symposium in Beijing to listen to companies’ opinions and suggestions on innovative medical device-related policies and understand Encourage the implementation effects of innovative medical device policies, and study ideas for further encouraging the innovative development of medical devices.