Medical device approval undergoes major reform, reducing R&D costs and speeding up product launches

2019-09-03 17:43

This means that the approval of clinical trials in the research and development of medical device products will be further reduced, and enterprises will not only save a lot of cost in the research and development of manufactured products, but also save time and cost, and accelerate the launch of manufactured products.

The notice points out that individuals seeking clinical trial approval requirements may communicate with the National Medical Products Administration's Medical Device Technical Evaluation Center (referred to as the "Center") based on the "Notice on Unrelated Incidents for Medical Device Case Trials Requiring Approval" (State Food and DrugAdministration Notice No. 184 of 2017) and the Center for Medical Device Technical Evaluation (hereinafter referred to as the "CenterPeripheral"). From the date of acceptance and payment of the case trial application, within 60 working days, if the applicant has not received feedback from the Center (including expert consultation meeting reports andsupplementary information reports) or has not commenced the clinical trial, and subject to the conditions of maintaining the method of submission and effective mailing, the trial can be initiated.

For approved case trials, the Center will publish the acceptance number, applicant's name and address, trial medical device name, model specifications, structure, and composition on the Center's website, and will inform the applicant through the Center's web notification, eliminating the need for separate clinical trial approval letters.

Furthermore, other clinical trial approval requirements for medical devices shall follow relevant regulations such as the Regulations for the Supervision and Administration of Medical Devices.

The   announcement states that the aforementioned approval procedures have been in effect since its publication, which was on March 29th.

In practice, the day before the issuance of the announcement (March 28th), the National Medical Products Administration held a symposium on the innovation, development, and review of medical devices in Beijing, where they gathered insights and suggestions from companies regarding policies related to innovative medical devices. This initiative aimed to understand the implementation effects of policies encouraging innovative medical device development and to discuss further strategies to promote the innovation and development of medical devices.