Great changes in medical device approval, R & D costs are greatly reduced, and products are accelerated to market

The National Medical Products Administration issued the Announcement on Adjusting the Approval Procedures for Clinical Trials of Medical Devices (referred to as the "Announcement"), which will further reform the approval of clinical trials of medical devices. It clearly states that where no opinion from the Center for Medical Device Evaluation is received within 60 working days from the date of acceptance and payment of the application for approval of medical device clinical trials, the clinical trial may be carried out.

　　This means that the approval of clinical trials in the research and development link of medical device products has been further streamlined. Enterprises not only save a lot of costs in product research and development, but also greatly save time costs, and products can be launched to the market at an accelerated pace.

　　The Announcement states 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 Center for Medical Device Evaluation) in accordance with the Announcement on Matters Concerning 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, on the premise that the reserved contact information and mailing address are valid, if the applicant does not receive opinions from the Center for Medical Device Evaluation (including notices of expert consultation meetings and notices for supplementary materials), the applicant may carry out the clinical trial.

　　For applications approved to carry out clinical trials, the Center for Medical Device Evaluation will publish the acceptance number, the applicant's name and domicile, the name, model and specification, structure and composition of the investigational medical device on the official website of the center, and notify the applicant of the review result through the website. No paper clinical trial approval document will be issued anymore.

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

　　The Announcement states that the above-mentioned approval procedure shall come into force as of the date of issuance, that is, it has been implemented starting from March 29.

　　In fact, before the issuance of the Announcement (March 28), the National Medical Products Administration held a symposium on innovative development and review and approval reform of medical devices in Beijing, to listen to enterprises' opinions and suggestions on policies related to innovative medical devices, understand the implementation effect of policies encouraging innovative medical devices, and study the working ideas for further encouraging the innovative development of medical devices.

　　In the author's opinion, the reform of this approval procedure is an effective measure matching the medical device registrant system, which will greatly improve the research and development enthusiasm of enterprises, scientific research institutions and other entities. Especially in regions where the registrant system has been piloted, innovative medical device products will be launched to the market at an accelerated pace.

　　The 60-day waiting period has extremely strong predictability and greatly improves the efficiency of research and development projects. The great development of domestic medical devices is just around the corner.