Great changes in medical device approval! Research and development costs have dropped significantly, accelerating the launch of products

The State Drug Administration issued the "Announcement on the adjustment of medical device clinical trial approval process" (the "Announcement"), to make further changes to the approval of medical device clinical trials. It is pointed out that, since the medical device clinical trial approval application acceptance and payment of fees within 60 working days from the date of receipt of the device review center comments, you can carry out clinical trials.

This means that the medical device product development link clinical trial approval and then streamlined, companies not only save a lot of costs in product development, time costs will also be greatly saved, the product to speed up the market.

The Notice points out that the applicant can communicate with the State Drug Administration Medical Device Technical Review Center (hereinafter referred to as the apparatus review center) according to the "Notice on matters relating to the communication of medical device clinical trial applications subject to approval" (State Food and Drug Administration Notice No. 184 of 2017) before making an application for clinical trial approval. Within 60 working days from the date of acceptance of the application for clinical trial approval and payment of fees, the applicant has not received comments from the instrumental review center (including notification of expert consultation meetings and notification of additional information) on the premise that the pre-determined contact information and mailing address is valid, the clinical trial can be conducted.

For consent to carry out clinical trials, the Instrumentation Review Center will accept the number, the name and residence of the applicant, the name, model specifications, structure and composition of the medical device for testing in the Instrumentation Review Center website, and the review results through the website of the Instrumentation Review Center to inform the applicant, no longer issued clinical trial approvals.

Other requirements for the approval of clinical trials of medical devices, in accordance with the "Medical Device Registration Administration" and other relevant provisions.

The Notice said that the above approval procedures have been in effect since the date of publication, that is, March 29 has begun to implement.

In fact, the day before the Notice was issued (March 28), the State Drug Administration held a symposium on medical device innovation and development and review and approval reform in Beijing to listen to the views and suggestions of enterprises on policies related to innovative medical devices, to understand the effect of the implementation of policies to encourage innovative medical devices, and to study ideas to further encourage the development of medical device innovation.

In my opinion, this change in the approval process is a powerful measure to complement the medical device registrar system, will greatly improve the enthusiasm of enterprises and research institutions and other research and development, especially in areas where the registrar system has been piloted, the innovative medical device products will be accelerated to market.

The 60-day waiting period is highly predictable, greatly improving the return on investment for R&D projects, and the great development of domestic medical devices is just around the corner.