Major Changes in Medical Device Approval, Greatly Reduced R & D Costs, and Products Accelerated to Market

This means that the approval of clinical trials in the R&D link of medical device products will be further reduced. Enterprises will not only save a lot of costs in product research and development, but also greatly save time costs, accelerating the launch of products.

　　The Announcement points out that before submitting an application for clinical trial approval, the applicant may communicate with the Center for Medical Device Evaluation of the National Medical Products Administration (hereinafter referred to as the CME) in accordance with the *Announcement on Matters Related to Communication and Exchange for Clinical Trial Applications of Medical Devices Requiring Approval* (Announcement No. 184 of 2017 issued by the former China Food and Drug Administration). Within 60 working days from the date of acceptance and payment of the clinical trial approval application, if the applicant has not received the opinion from the CME (including the expert consultation meeting notification and the supplementary data notification) on the premise that the reserved contact information and mailing address are valid, the applicant may launch the clinical trial.

　　For clinical trials approved to be carried out, the CME will publish the acceptance number, the applicant's name and residence, the name, model and specification, structure and composition of the investigational medical device on the official website of the CME, and notify the applicant of the review result through the website of the CME, and will no longer issue a clinical trial approval document.

　　In addition, other medical device clinical trial approval applications shall be implemented in accordance with relevant regulations such as the *Measures for the Administration of Medical Device Registration*.

　　The Announcement states that the above-mentioned approval procedures shall come into force as of the date of issuance, that is, they have been implemented since March 29.

　　In fact, before the Announcement was issued (March 28), the National Medical Products Administration held a symposium on innovative development and review approval reform of medical devices in Beijing, listened to enterprises' opinions and suggestions on policies related to innovative medical devices, checked the implementation effect of policies encouraging innovative medical devices, and discussed working ideas to further promote the innovative development of medical devices.