Regulations on the Supervision and Administration of Medical Devices (January 4, 2000, the State Council of the People's Republic of China Decree No. 276 published February 12, 2014, the State Council 39th executive meeting revised and adopted according to the May 4, 2017 "the State Council on the revision of the" Regulations on the Supervision and Administration of Medical Devices "decision" the first revised December 21, 2020, the State Council No. 1 ...

Description: The State Drug Administration (SDA) released a document on January 15, 2025 on its official website to publicly solicit comments and suggestions on the Draft Revised Code of Practice for the Quality Management of Medical Device Manufacturing (Draft Revision for Comment). In order to facilitate the regulatory authorities and enterprises to understand the main points of the draft revision and the 2014 version of the "Code for Quality Management of Medical Device Manufacturing", the State Drug Administration (SDA) published a document on its official website on January 15, 2025 to solicit comments and suggestions from the public.

Index No. FGWJ-2025-121 Subject Classification Regulatory Documents / Normative Documents Title Notification of the Comprehensive Department of the State Drug Administration on the Project of Medical Device Industry Standard for "Medical Devices Adopting Brain-Computer Interfaces Quality Requirements and Evaluation Methods of Electroencephalography Datasets Used for Artificial Intelligence Algorithms" Date of Issue: 2025-02-25 CIRC: In order to satisfy the urgent need for supervision and to help promote In order to meet the urgent regulatory needs and to help promote the ...

Index No. FGWJ-2025-117 Subject Classification Regulatory Documents / Normative Documents Title Report on Medical Device Registration Work in FY 2024 Issue Date 2025-02-13 In FY 2024, the State Drug Administration, guided by Xi Jinping's Thought on Socialism with Chinese Characteristics in the New Era, comprehensively carried out the spirit of the 20th National Congress of the Party, and the Second and Third Plenary Sessions of the 20th CPC Central Committee, and followed the principle of "political, strong supervision, safety, development and development". "Speaking Politics, Strengthening Supervision, Ensuring Safety, Promoting Development and Benefiting the People's Life"...

Index No. FGWJ-2024-138 Subject Classification Title Interpretation of the Notice on Standardizing the Work of Classifying and Defining Medical Device Products Issue Date 2024-05-11 In order to further standardize the work of classifying and defining medical device products, combined with the actual situation of classifying and defining medical device products in our country, the State Drug Administration (SDA) has organized the revision of the former General Office of the Food and Drug Administration (GODA) "Notice on Standardizing the Work of Classifying Medical Device Products" (Food... Classification of Medical Device Products" (Food and Drug...

　　For the implementation of the "supervision and management of medical devices regulations", the full implementation of medical device registrants (hereinafter referred to as the registrant) quality and safety of the main responsibility to further strengthen the registrant entrusted to the supervision and management of the production, and effectively prevent and control the risk of medical device quality and safety. Now on the relevant matters announced as follows: First, the strict implementation of the main responsibility of medical device registrants (a) registrants should fully implement the main responsibility for the quality and safety of medical devices, the establishment of a...

　　In 2024, the State Drug Administration adhered to Xi Jinping's thought of socialism with Chinese characteristics in the new era as a guide, fully implemented the 20th CPC National Congress and the spirit of the 2nd and 3rd Plenary Sessions of the 20th CPC Central Committee, implemented the requirements of the "four most stringent", in accordance with the work idea of "political, strong supervision, safety, development and people's livelihood. In accordance with the working idea of "speaking politics, strengthening supervision, ensuring safety, promoting development and benefiting people's life", integrating high-quality development and high-level safety, the standardization work of medical devices has stepped up to a new level, and the high standard has helped the scientific supervision of medical devices, promoted technological innovation, and led to the...