China Implements Implied Consent System for Medical Device Clinical Trials

VCBeat (WeChat ID: vcbeat) has learned that, in order to implement the "Opinions on Deepening the Reform of the Review and Approval System to Encourage Innovation in Drugs and Medical Devices" (Tingzi [2017] No. 42) issued by the General Office of the CPC Central Committee and the General Office of the State Council, further optimize the clinical trial approval process, and adjust the approval procedures for medical device clinical trials, the following matters are hereby announced:

Prior to submitting an application for approval of a clinical trial, the applicant may engage in communication with the Center for Medical Device Evaluation (CMDE) of the National Medical Products Administration (hereinafter referred to as the “CMDE”) in accordance with the Announcement on Matters Concerning Communication and Exchange Regarding Applications for Approval of Clinical Trials of Medical Devices Requiring Approval (Announcement No. 184 of 2017 issued by the China Food and Drug Administration). Within 60 working days from the date of acceptance of the application for clinical trial approval and payment of the relevant fees, if the applicant has provided valid contact information and mailing address but has not received any feedback from the CMDE (including notifications for expert consultation meetings or requests for supplementary materials), the clinical trial may be initiated.

For clinical trials that have been approved, the Center for Medical Device Evaluation (CMDE) will publish the application number, name and address of the applicant, name, model, specification, structure, and composition of the investigational medical device on the CMDE website. The review results will be communicated to the applicant via the CMDE website, and no separate clinical trial approval document will be issued.

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

In any case, the reform of this system will further shorten the time to market for innovative medical devices.

The implied approval system for clinical trials of drugs was officially launched in November last year.