Interpretation of "Medical Device Clinical Trial Institutions Conditions and Record Management Measures"

Medical Network November 27 hearing recently, the Food and Drug Administration jointly with the National Health and Family Planning Commission jointly issued the "medical device clinical trial conditions and record management approach" (hereinafter referred to as the "record"), will be January 1, 2018 Execution.

In accordance with the "Opinions on Deepening the Innovation of Medical Device Innovation to Promote the Reform of the Examination and Approval System for Examination and Approval" (Office Word [2017] No. 42) issued by the General Office of the CPC Central Committee and the General Office of the State Council, and the " <医疗器械监督管理条例>(Decree No. 680 of the State Council of the People's Republic of China), in order to implement the record management of clinical trial institutions for medical devices.In order to implement the State Council's policy of decentralization, decentralization and management, and optimization of services, the reform of the medical device examination and approval system To encourage more medical institutions with high-quality resources to participate in the clinical trials of medical devices, strengthen the responsibility of sponsors and standardize the clinical trial process of medical devices. The Food and Drug Administration in conjunction with the State Health and Family Planning Commission, after public consultation, repeatedly revised and formulated the " ".

This approach shall apply to the administration of the recordkeeping of clinical trials carried out by medical devices (including in vitro diagnostic reagents products managed according to medical devices) within the territory of the People's Republic of China Medical institutions conducting clinical trials of medical devices and other blood testing clinical trials that carry in vitro diagnostic reagents Center and center blood stations, located above the city level disease Prevention and control centers, drug treatment centers and other non-medical institutions should be implemented in accordance with the provisions of the record.

"Record approach" is divided into general principles, record conditions, filing procedures, supervision and management and a total of twenty-five chapters.

The overall requirements, a clear purpose, the definition and scope of application for clinical trials in China carrying out clinical trials of medical equipment for the record.

In order to strengthen the management of high-risk medical devices, to ensure the safety of subjects and improve the quality of clinical trials, the provisions listed in the need for clinical trial approval of the third category Products, clinical trials should be carried out within the professional scope of Grade-3 A-level medical institutions; the principal investigators who stipulate the clinical trials of innovative medical device products or type-III medical device products that need to undergo clinical trial approval shall have senior technical titles and participated in 3 or more medical devices or drug clinical trials and so on.

The procedures for the filing shall be established by the State Food and Drug Administration in the form of a record management information system for clinical trial institutions of medical devices (hereinafter referred to as the filing system); clinical trial institutions for medical devices may undertake clinical trials of medical devices after obtaining the record numbers for filing.

Supervision and management, made it clear that the food and drug regulatory authorities above the provincial level and the health and family planning administrative department in accordance with the division of labor is responsible for organizing the clinical trial agency supervision and management and information communication responsibilities.

The record filing system is an information platform used by medical trial clinics to register medical device clinical trials, supervise the food and drug regulatory agencies, and manage the clinical trial filing by the administrative departments of public health and family planning. The record filing system is established by the Food and Drug Administration and the daily management is controlled by the Food and Drug Administration General Administration of Verification Center is responsible for the record system in the Food and Drug Administration Web site (http://www.cfda.gov.cn) 'online service' section, the clinical trial equipment of medical devices should be in the filing system in accordance with the relevant requirements for the record, The public can log in to the filing system to check the list of clinical trials of medical devices filed, professional and contact information.

In order to ensure the continuous development of clinical trials, from January 1, 2018 to December 31, 2018, medical device clinical trial sponsors can continue to choose food by-products drug The State Administration of Taxation will carry out clinical trials with drug clinical trial institutions accredited by the National Health and Family Planning Commission, in which clinical trial sponsors of in vitro diagnostic reagents may also continue to follow the regulations of the State Food and Drug Administration <medical instruments Registration Management> and <体外诊断试剂注册管理办法>(SFDA [2014] No. 144), the provincial health and medical institutions are selected to carry out clinical trials. For in-vitro diagnostic reagents for special purposes, they can be treated at the level of municipal-level or above-required diseases Prevention and Control Center, specialist hospital Or inspection and quarantine, drug rehabilitation centers and other agencies to carry out clinical trials.

Since January 1, 2019, the sponsor of the clinical trial of medical devices (including in vitro diagnostic reagents) should select the clinical trial institutions of medical devices that have been filed with the filing system, and according to the Regulations for Quality Control of Clinical Trial of Medical Devices (CFDA National Health and Family Planning Commission No. 25) and the "In vitro diagnostic reagents registration management approach" (Food and Drug Administration Order No. 5) the relevant requirements of clinical trials.