Medical device approval undergoes major changes, research and development costs are greatly reduced, and products are accelerating their launch

The National Medical Products Administration has issued a notice on adjusting the approval procedures for clinical trials of medical devices (referred to as the "Notice"), which aims to make further changes to the approval process for clinical trials of medical devices. It is pointed out that within 60 working days from the date of acceptance and payment of the medical device clinical trial approval application, if no opinions are received from the device review center, clinical trials can be carried out.

This means that the clinical trial approval process in the research and development of medical equipment products will be further streamlined, and companies will not only save a lot of costs in product development, but also greatly save time costs, accelerating the launch of products.

The Announcement states that before submitting a clinical trial approval application, the applicant may communicate with the Medical Device Technical Review Center (hereinafter referred to as the Center) of the State Food and Drug Administration in accordance with the Notice on Relevant Matters Concerning Communication and Exchange of Medical Device Clinical Trial Applications Subject to Approval (Notice No. 184 of the State Food and Drug Administration in 2017). Within 60 working days from the date of acceptance and payment of the clinical trial approval application, if the applicant has not received any opinions from the Institutional Review Center (including expert consultation meeting notices and supplementary information notices), provided that the reserved contact information and mailing address are valid, the clinical trial can be conducted.

For those who agree to conduct clinical trials, the Institutional Review Center will publish the acceptance number, applicant name and address, name, model specifications, structure and composition of the medical device used in the trial on the Institutional Review Center website, and inform the applicant of the examination results through the Institutional Review Center website. Clinical trial approvals will no longer be issued.

Other requirements for clinical trial approval of medical devices shall be implemented in accordance with relevant regulations such as the "Regulations on the Administration of Medical Device Registration".

The Announcement states that the above approval procedures will be implemented from the date of publication, which is March 29th.

In fact, before the announcement was issued (March 28th), the National Medical Products Administration held a symposium on the innovation and development of medical devices and the reform of evaluation and approval in Beijing, listening to the opinions and suggestions of enterprises on policies related to innovative medical devices, understanding the implementation effect of policies encouraging innovative medical devices, and studying further work ideas to encourage the innovation and development of medical devices.

In the author's opinion, this reform of the approval process is a powerful measure that is in line with the registration system for medical devices. It will greatly enhance the R&D enthusiasm of enterprises and research institutions, especially in areas where the registration system has been piloted. Innovative medical device products will be accelerated to the market.

The 60 day waiting period is highly predictable, greatly increasing the rate of research and development projects, and the great development of domestic medical devices is just around the corner.