The Beijing, Tianjin, Liaoning, Shanghai, Zhejiang, Shandong, Hubei, and Guangdong provincial (municipal) Food and Drug Administrations, National Institutes for Food and Drug Control (CFDA Medical Device Standards Management Center), Dental Medical Devices Testing Center of Peking University School of Stomatology, Beijing Hua Guang Certification of Medical Devices Co., Ltd.:

According to the arrangement of the development and revision of the Medical Device Industrial Standards 2017, the developed and revised items of the Medical Device Industrial Standards 2017 are hereby issued to you, including 71 subsidy items from the central government to the local for development and revision of medical device industrial standards, and 15 central finance supporting items for development and revision of medical device industrial standards. For efficient development and revision of the standards, you should obey the following requirements:

I. The undertakers of the development and revision of the standards shall work under the Administrative Measures for Medical Device Standards (Order of CFDA No. 33) to ensure that all tasks are completed as required.

II. The CFDA Medical Device Standards Management Center shall coordinate the undertakers for development and revision of the standards and strengthen management and inspection guidance. Where mandatory standards are involved, the relevant medical devices Standardization Technical Committee shall know and master the main products involved. For the revised standard content with significant change and the requirement of providing the implementation time and registration of the standard, technical suggestions shall be proposed and included in the standard review and the materials submitted for approval.

III. The provincial (municipal) Food and Drug Administrations shall spare no effort to supervise and regulate the undertakers in the development and modification of the standards in the administrative region, and urge the relevant units draft and verify the standards, seek for opinions, review the standards and submit for approval as required.

IV. The provincial (municipal) Food and Drug Administrations and the undertakers of the standards development and revision items of medical devices shall, in strict accordance with the administrative regulations of national financial funds and financial system requirement, reinforce the supervision and management to the allocation and use of the funds for development and revision of the standards to improve the fund application benefit through special fund for special purpose.

Appendix:

        1. Subsidy items from the central government to the local for development and revision of medical device industrial standards in 2017
        2. Central finance supporting items for development and revision of medical device industrial standards in 2017

General Office of China Food and Drug Administration
July 7, 2017