The NMPA issued the “Regulation on the Supervision and Administration of Medical Devices” on January 7, 2025, a revised version of the same-named regulation implemented on June 1, 2021. It underwent an amendment on December 6, 2024, and the final version was released in less than a month, reflecting the strong determination of the top-level reform.
The regulation closely follows the “Law on Medical Device Management (Draft)” released in August 2024, aiming to pave the way for the formal implementation of the new law.
It comes 4 days after the release of “Opinions on Deepening the Reform of Drug and Medical Device Regulation to Promote High-Quality Development of the Pharmaceutical Industry” by China State Council. It offers incentives for overseas manufacturers to enter and innovate in the China market, including priority approval for high-end and urgently needed devices, priority testing for innovative medical devices, alignment with international standards, and facilitating transition to domestic production, etc. For more information on the State Council document, please click HERE
Key Changes
Compared to the regulation implemented on June 1, 2021, the key changes are highlighted below:
General Provisions
- Enhanced Principles of Supervision and Management
Added principles of “comprehensive control, scientific supervision, and societal co-governance,” emphasizing lifecycle regulation of medical devices, scientific regulatory methods, and the joint participation of all sectors of society.
- Support for Industrial Policies
Included provisions for the planning and formulation of policies for the medical device industry, explicitly incorporating medical device innovation as a development priority, with measures such as prioritized review and approval of innovative devices to promote high-quality industrial development.
Medical Device Registration
- Further Defined Responsibilities of Registrants and Filers
Clarified that medical device registrants and filers are responsible for the quality management of the product throughout its lifecycle and legally accountable for its safety and effectiveness. In contrast, the 2017 version primarily held manufacturers as the responsible entities.
- Detailed Requirements for Registration Application Materials
Made requirements for registration application materials more specific, such as allowing inspection reports to be self-issued or provided by qualified institutions, and detailing conditions under which clinical evaluation is exempt:
Article 24:
Clinical evaluation is required for the registration and filing of medical device products unless one of the following conditions is met:
(1) The mechanism of action is clear, the design is finalized, the manufacturing process is mature, and similar devices have been on the market for many years without serious adverse events, with no change to the intended use;
(2) The safety and effectiveness of the device can be proven through non-clinical evaluation.
The drug regulatory authority shall develop guidelines for clinical evaluation of medical devices.
- Optimized Registration Review Procedures
Improved registration review procedures, specifying timelines for technical review opinions from review institutions and decision-making timelines for regulatory authorities to increase registration efficiency:
Article 17:
Drug regulatory authorities accepting registration applications must transfer the application materials to technical review institutions within three working days of acceptance. Technical review institutions must submit their review opinions to the accepting authority after completing the review, which will serve as the basis for approval decisions.
- Conditional Approval and Emergency Use
Introduced provisions for conditional approval and emergency use of devices urgently needed for treating rare diseases, life-threatening conditions without effective treatments, or public health emergencies.
Medical Device Production
- Clear Production Licensing Conditions
Defined the conditions for obtaining production licenses for Class II and Class III devices, requiring submission of specified materials and the registration certificate for the device to be produced.
- Detailed Provisions for Contract Manufacturing
Provided more detailed regulations on contract manufacturing of medical devices, clarifying the rights, obligations, and responsibilities of registrants, filers, and contract manufacturers, as well as the qualification requirements for the latter:
Article 34:
Medical device registrants and filers must sign agreements with contract manufacturers specifying their rights, obligations, and responsibilities. Contract manufacturers must organize production in accordance with laws, regulations, medical device production quality management standards, mandatory standards, product technical requirements, and the agreement, while being subject to supervision by the commissioning party.
- Strengthened Quality Management System Requirements
Emphasized that registrants, filers, and contract manufacturers must establish and maintain a quality management system appropriate to the devices being produced and conduct regular self-inspections, submitting self-inspection reports.
Medical Device Operations and Use
- Clear Operating Licensing Conditions
Defined conditions for obtaining operating licenses for Class III devices, requiring the submission of specified materials, with timelines for review and decisions also stipulated:
Article 42:
Regulatory authorities must review application materials for operating licenses, conduct necessary inspections, and make decisions within 20 working days of accepting the application.
- Added Provisions for Online Sales
Introduced requirements for online sales, specifying that only registrants, filers, or licensed medical device operators may engage in online sales, and outlined the management obligations for e-commerce platform operators.
- Detailed Management Requirements for User Units
Provided more detailed requirements for the management of user units, including the handling of reusable devices, the management of single-use devices, and the inspection, calibration, maintenance, and care of devices.
Adverse Events and Recalls
- Enhanced Monitoring System Requirements
Required registrants and filers to establish monitoring systems for adverse events, with dedicated institutions and personnel actively conducting monitoring.
- Detailed Re-evaluation Provisions
Clarified circumstances under which registrants and filers must conduct re-evaluations and specified handling measures based on the results.
- Stricter Recall Regulations
Imposed stricter recall requirements, mandating immediate recalls for defective devices and appropriate corrective actions, with harsher penalties for non-compliance.
Supervision and Inspection
- Establishment of Inspector System
Introduced a professional inspector system to strengthen medical device supervision and inspection.
- Introduction of Interview System
Allowed higher-level authorities to interview key officials of departments or local governments that fail to identify systemic safety risks or eliminate safety hazards promptly.
Legal Responsibilities
- Increased Penalty Severity
Significantly increased penalties for violations, such as producing or operating Class II or III devices without registration certificates, with fines raised from 10–20 times the value of goods to 15–30 times.
- Expanded Penalty Types
Introduced penalties for legal representatives, principal leaders, and responsible personnel of violating entities, such as confiscation of income obtained during violations and fines based on income, as well as bans on engaging in medical device production and operations.
- Strengthened Credit Punishments
Emphasized the establishment of credit archives for registrants, filers, manufacturers, operators, and user units, with increased inspection frequencies and intensified penalties for those with poor credit records.