Summary of Hot Regulatory and Support Policies in China’s Medical Field in November 2025: Multiple Provinces and Cities Issued Action Plans to Promote High-Quality Development of the Medical Device Industry

November 3, 2025： “Guidelines for the Registration and Review of Intracranial Thrombectomy Stents”

To strengthen the guidance for medical device registration applications and technical review, the Center for Medical Device Evaluation first released a draft for comments in September 2024 (Recommended reading: Public Consultation丨National Medical Products Administration Issues “Guidelines for the Registration Review of Intracranial Thrombectomy Stents (Draft for Comments)”). After extensively incorporating feedback and suggestions from the industry, it organized the formulation of the “Guidelines for the Registration Review of Intracranial Thrombectomy Stents”, which is now officially released.

November 3, 2025： “Review Key Points for Disposable Balloon Uterine Stents (Draft for Comment)” “Guidelines for Registration Review of Endotracheal Intubation Products (2025 Revised Edition) (Draft for Comment)”

In accordance with the relevant requirements of the project plan for the guiding principles for the registration review of medical devices by the National Medical Products Administration, the Center for Medical Device Evaluation has organized the compilation of the “Key Points for the Evaluation of Disposable Balloon Uterine Stents (Draft for Comment)” (Annex 1) and the “Guiding Principles for the Registration Review of Endotracheal Intubation Products (2025 Revised Edition) (Draft for Comment)” (Annex 2). The drafts for comment have now been formulated and will be publicly soliciting opinions online from this date onwards.

November 4, 2025 “Guiding Opinions on Further Improving the Procurement of Pharmaceuticals and Medical Consumables”

The “Guiding Opinions” is divided into six parts, namely: General Requirements, Optimizing Procurement Models, Strengthening Price Management, Promoting Policy Coordination, Improving the Efficiency of Supervision and Services, and Organizational Implementation.

November 5, 2025： “Revised and Issued: ‘Good Manufacturing Practice for Medical Devices'”

The revised “Specification” has a total of 15 chapters and 132 articles. It adds three chapters: Quality Assurance, Verification and Validation, and Contract Manufacturing and Outsourcing Processing. The provisions in other chapters have also been revised to varying degrees.The new version of the “Specifications” embodies the following characteristics: First, it further strengthens the concept of quality risk management to ensure that risk management is consistent from R&D and design to after-sales service; second, it further strengthens the construction of the quality assurance system within the quality management system to ensure the continuous stability of large-scale production and manufacturing processes; third, it further strengthens the management requirements for new business forms such as commissioned production, clarifies responsibilities in all links, and ensures a high level of safety throughout the entire chain; fourth, it further emphasizes the important value of the key link of “verification and validation” in terms of operational specifications and improving the reliability of results, to ensure that key elements in the product production process are effectively controlled; fifth, it further encourages the digital and intelligent transformation of production and manufacturing, ensuring the effective application of artificial intelligence, information technology, and unique identifiers for medical devices.

November 11, 2025 : “Suggestions for Adjusting Some Contents of the ‘Catalogue of Medical Device Classifications'”

In accordance with the “Work Procedures for the Dynamic Adjustment of the Medical Device Classification Catalogue” and relevant requirements, the Medical Device Standardization Administration Center of the National Medical Products Administration, based on the adjustment opinions collected in the early stage, organized the professional groups of the Medical Device Classification Technical Committee to study and formulate the “Suggestions on Adjusting Some Contents of the Medical Device Classification Catalogue” (Annex 1).It is now open for public consultation.
November 10, 2025: “Guidelines for Registration Review of Laparoscopic Endoscopic Surgery Systems Part 5: Patient Model Test Research (Draft for Comments)”

In accordance with the relevant requirements of the plan for formulating and revising the guiding principles for the registration review of medical devices by the National Medical Products Administration, the Center for Medical Device Evaluation has organized the drafting of the “Guiding Principles for the Registration Review of Laparoscopic Endoscopic Surgery Systems – Part 5: Patient Model Test Research (Draft for Comments)” (Annex 1).It is now open for public consultation.

November 10, 2025： “Guidelines for the Review of Clinical Trial Registration of Inferior Vena Cava Filters (Draft for Comment)”

To standardize the clinical trial requirements for inferior vena cava filters, after preliminary investigations, research, and expert discussions, the Device Evaluation Center has drafted the “Guidelines for the Review of Clinical Trial Registration of Inferior Vena Cava Filters (Draft for Public Comment)” (Annex 1) and is now publicly soliciting opinions from the society.

November 10, 2025： “Guidelines for the Review of Clinical Trial Registration of Wearable External Automated Defibrillation Devices (Draft for Comments)”

To standardize the clinical evaluation requirements for wearable external automatic defibrillation devices and the clinical evaluation pathway decision-making and clinical evaluation requirements for extracorporeal membrane oxygenation (ECMO) system products, after preliminary investigation and research as well as expert discussions, the Device Evaluation Center has drafted the “Guidelines for Clinical Trial Registration Review of Wearable External Automatic Defibrillation Devices (Draft for Comments)” and the “Guidelines for Registration Review of Clinical Evaluation Pathway Decision-Making for Extracorporeal Membrane Oxygenation System Products (Draft for Comments)” (Annex 1 and Annex 2). These drafts are now open to the public for comments.

November 10, 2025： “Guidelines for the Registration Review of Percutaneous Coronary Intervention Physiological Function Testing Products (Draft for Comments)”

In accordance with the relevant arrangements of the formulation and revision plan for the regulatory review guidelines for medical device registration by the National Medical Products Administration, the Center for Medical Device Evaluation has organized the compilation of the “Regulatory Review Guidelines for Registration of Percutaneous Coronary Intervention Physiological Function Testing Products (Draft for Comment)” (Annex 1), and is publicly soliciting opinions from now on.

November 11, 2025： “Guidance for Registration Review on Reliability Evaluation of Tube Assemblies for X-ray Computed Tomography Equipment (Draft for Comments)”

In accordance with the relevant requirements of the formulation and revision plan for the registration review guidelines for medical devices of the National Medical Products Administration, the Center for Medical Device Evaluation has organized the drafting of the “Registration Review Guidelines for Reliability Evaluation of Tube Assemblies for X-ray Computed Tomography Equipment (Draft for Comments)” (Annex 1). We are now publicly soliciting opinions from the society.

November 18，2025： “Several Measures of Anhui Province on Comprehensively Deepening the Supervision Reform of Drugs and Medical Devices to Promote the High-Quality Development of the Pharmaceutical Industry”

To thoroughly implement the spirits of the Third and Fourth Plenary Sessions of the 20th Central Committee of the Communist Party of China, and to carry out the decisions and arrangements of the General Office of the State Council on comprehensively deepening the reform of drug and medical device supervision to promote the high-quality development of the pharmaceutical industry, as well as the work requirements of the Provincial Party Committee and the Provincial Government, 17 departments including the Provincial Drug Administration, the Provincial Development and Reform Commission, the Provincial Health Commission, and the Provincial Market Supervision Bureau jointly formulated and issued the “Several Measures” recently. Centering on five aspects, namely “vigorously supporting the research and innovation of drugs and medical devices”, “fully supporting the inheritance and innovative development of traditional Chinese medicine”, “striving to improve the quality and efficiency of drug and medical device review and approval”, “comprehensively enhancing the compliance level of the pharmaceutical industry”, and “strengthening element resource support in an all-round way”, 21 specific reform measures are put forward.

November 21，2025： “Liaoning Province’s Priority Registration Procedures for Class II Medical Devices”

To thoroughly implement the “Opinions of the General Office of the State Council on Comprehensively Deepening the Reform of Drug and Medical Device Supervision and Promoting the High-Quality Development of the Pharmaceutical Industry”(State Council Document No. [2024] 53), the Provincial Drug Administration has organized the revision of the “Liaoning Province Priority Registration Procedures for Class II Medical Devices”. The main revisions and improvements include relevant contents such as applicable situations and requirements for declaration materials (see Annex 1), which shall come into effect from the date of issuance of this announcement.

November 24, 2025： “Several Measures of Shanghai Municipality on Comprehensively Deepening the Reform of Drug and Medical Device Supervision and Promoting the High-Quality Development of the Pharmaceutical Industry”

The General Office of the Shanghai Municipal People’s Government issued the “Several Measures of Shanghai Municipality on Comprehensively Deepening the Reform of Drug and Medical Device Supervision to Promote the High-Quality Development of the Pharmaceutical Industry”. It introduced policies from multiple dimensions such as review and approval, regulatory coordination, medical insurance connection, and industrial ecology, with the core focusing on the three main lines of “supporting innovation, optimizing supervision, and collaborative empowerment”. Measures support shortening the review and approval time limit for clinical trials of innovative drugs to 30 working days, promoting pilot experience, and improving the quality and efficiency of clinical trials; reforming the review and approval procedures for supplementary applications of chemical drugs to shorten the approval time limit; striving for relevant pilots for drugs produced overseas to accelerate the listing of the first generic varieties; improving the change process for marketed drugs, selecting varieties to carry out pilot projects for segmented production of biological products, promoting cross-border segmented production pilots and providing customs clearance convenience, and exploring pilot projects for continuous drug manufacturing. At the same time, focusing on key areas such as cell and gene therapy, establishing service lists, providing proactive guidance, and accelerating the transformation and listing of innovative medical devices.

November 25，2025: “Guidelines for the Registration Review of Navigation and Positioning Systems for Joint Replacement Surgery (Draft for Comments)”

To scientifically guide applicants in developing joint replacement surgery navigation and positioning systems, preparing and compiling registration application materials, and to ensure the technical evaluation of medical device products is carried out effectively, our center has organized the drafting of the “Guidelines for the Registration Review of Joint Replacement Surgery Navigation and Positioning Systems (Draft for Comments)” (Annex 1), and is now publicly soliciting opinions.

November 25，2025: “Several Measures of Beijing Municipality for Promoting the High-Quality Development of the Medical Device Industry”

The Beijing Municipal Bureau of Economy and Information Technology and six other departments jointly issued policies to support the development of artificial intelligence medical devices, clinical research and registration of innovative devices, implementation and promotion of achievements, ecological agglomeration, digital empowerment, and going global. Specific measures such as funding support, process optimization, and platform construction were proposed, with an effective period until December 31, 2028.

November 27, 2025： “Guidelines for the Registration Review of Glucose-6-Phosphate Dehydrogenase Detection Reagents (Draft for Comment)”

In accordance with the relevant requirements of the 2025 annual plan for formulating and revising the guidelines for the review of medical device registrations by the National Medical Products Administration, our center has organized the formulation and revision of a total of 4 guidelines for the review of medical device registrations, namely: “Guidelines for the Review of Registration of Glucose-6-Phosphate Dehydrogenase Detection Reagents (Draft for Comments)” (Annex 1), “Guidelines for the Review of Registration of Automatic Blood Group Analyzers (2025 Revised Edition) (Draft for Comments)” (Annex 2), “Guidelines for the Review of Registration of Human Epidermal Growth Factor Receptor 2 Gene Amplification Detection Reagents (Fluorescence In Situ Hybridization Method) (2025 Revised Edition) (Draft for Comments)” (Annex 3), and “Technical Guidelines for the Review of Registration of Hepatitis C Virus Nucleic Acid Genotyping Detection Reagents (2025 Revised Edition) (Draft for Comments)” (Annex 4). After research and discussion, the drafts for comments have now been formulated and will be publicly soliciting opinions online from this date onwards.

November 27, 2025 “Notice of the General Office of the Ministry of Finance and the Office of the National Healthcare Security Administration on Earnestly Doing a Good Job in the Budget Execution Management of the Subsidy Fund for Improving Medical Services and Security Capabilities (the Part of Medical Security Service Capacity Building)”

Ⅰ. Please include this budget revenue in the 2026 government revenue and expenditure classification item “1100249 Revenue from Transfer Payments for Common Fiscal Powers in Medical and Health Care”, and include the expenditure in the relevant items under “21015 Medical Security Management Affairs”.

Ⅱ. The budget for subsidy funds for improving medical services and security capabilities (the part for building medical security service capabilities) is included in the scope of normalized supervision over the implementation of transfer payment budgets. Financial departments at all levels shall promptly receive and log in budget indicators in the budget management integration system, keep the “tracking” mark unchanged, and rely on the transfer payment monitoring module of the budget management integration system to strengthen daily supervision and improve the standardization and effectiveness of the management and use of transfer payment funds.

III. Local financial and medical security departments shall earnestly implement the relevant requirements of the “Notice of the General Office of the Ministry of Finance and the General Office of the National Medical Security Administration on Earnestly Doing a Good Job in the Budget Execution Management of the Subsidy Fund for Improving Medical Services and Security Capabilities (the Part for Building Medical Security Service Capabilities)”. They shall adhere to attaching equal importance to accelerating the progress of budget execution and ensuring the standardized use of funds. They must not only attach great importance to budget execution work but also prevent various illegal and irregular behaviors such as falsely listing expenditures, using funds beyond the specified scope, and “rush spending” that ignores efficiency.