China Introduces Revised Medical Devices Supervision and Administration Regulations

by Angelita Hu Jan 22, 2025

On January 7, 2025, China's National Medical Products Administration (NMPA) officially released the Medical Devices Supervision and Administration Regulations (Hereinafter referred to as the 2025 version), replacing the 2017 version. Compared with the 2017 version, the 2025 version encompasses revisions in the general principles, registration and filing, production requirements, operation and use, adverse events monitoring and recalls, supervision and inspection, and legal responsibilities.

I. General Principles

1. Supervision Principles

The 2025 version introduces new principles, such as "full-process control, scientific supervision, and social co-governance," emphasizing the regulation of the entire lifecycle of medical devices, scientific regulatory methods, and the participation of all sectors of society.

2. Industry Policy Support

The 2025 version includes provisions for the formulation of medical device industry planning and policies, explicitly incorporating innovation in medical devices as a key development focus and providing priority review and approval for innovative devices to support high-quality industry development.

II. Registration and Filling

1. Responsibility of Registrants and Filers

The 2025 version clarifies that the registrants and filers of medical devices are responsible for quality management throughout the lifecycle and bear legal responsibility for product safety and efficacy. In contrast, the 2017 version primarily placed responsibility on manufacturing enterprises.

2. Detailed Requirements for Registration Application Materials

The 2025 version specifies more detailed requirements for registration application materials, such as allowing product testing reports to be either self-testing reports or reports from qualified testing institutions, and provides detailed provisions for situations exempt from clinical evaluation.

3. Optimized Registration Review Procedures

The 2025 version optimizes the registration review process, specifying deadlines for submitting technical review opinions and for the regulatory authority to make a decision, thus improving registration efficiency.

4. Conditional Approval and Emergency Use

The 2025 version introduces provisions for conditional approval and emergency use of medical devices needed for rare diseases, life-threatening conditions without effective treatment, or public health emergencies.

5. Change in Emergency Event Management

In the event of a major public health emergency or other serious threats to public health, China’s health commissions and the disease control and prevention administrations will jointly propose emergency use of medical devices, instead of solely the health commissions as in the 2017 version.

III. Production Requirements

1. Clarified Production License Application Conditions

The 2025 version clarifies the conditions for applying for production licenses for Class II and Class III medical devices, requiring submission of relevant compliance materials and the product registration certificate.

2. Detailed Contract Manufacturing Provisions

The 2025 version provides more detailed provisions for contract manufacturing of medical devices, defining the rights, duties, and responsibilities among registrants, filers, and contract manufacturers, along with qualifications for contract manufacturers.

3. Enhanced Quality Management System Requirements

The 2025 version emphasizes that registrants, filers, and contract manufacturers should establish a quality management system suitable for the medical devices they produce and conduct regular self-inspections, submitting self-inspection reports.

IV. Medical Device Operation and Use

1. Clarified Business License Application Conditions

The 2025 version clarifies the conditions for applying for a business license for Class III medical devices, specifying required materials and establishing timelines for the review and decision-making process.

2. New Provisions for Online Sales

The 2025 version introduces provisions for the online sale of medical devices, stating that operators engaged in online sales must be registered medical device entities or medical device operating enterprises and outlining the management responsibilities of e-commerce platform operators.

V.  Adverse Events Monitoring and Recalls

1. Strengthened Monitoring System Requirements

The 2025 version requires registrants and filers to establish an adverse event monitoring system and provide the necessary personnel and facilities to actively monitor adverse events related to their products.

2. Detailed Provisions for Re-Evaluation

The 2025 version includes more detailed provisions for re-evaluation, specifying situations where registrants and filers must proactively conduct re-evaluations and the measures to be taken based on the re-evaluation results.

3. Stricter Recall Provisions

The 2025 version strengthens recall provisions, requiring immediate recall of defective medical devices and corrective actions, with stricter penalties for failure to comply with recall regulations.

VI. Supervision and Inspection

1. Establishment of Professional Inspector System

The 2025 version establishes a professional and specialized inspector system to strengthen supervision and inspection of medical devices.

2. Clarification of Supervision and Inspection Authority

The 2025 version clarifies the supervisory and inspection powers of regulatory authorities, including on-site inspection, document review, and the seizure of items.

3. Introduction of Interview System

The 2025 version introduces an interview system, allowing higher-level authorities to hold interviews with the heads of departments or local governments that fail to identify safety risks or mitigate hazards in medical devices in a timely manner.

VII. Legal Responsibilities

1. Increased Penalties

The 2025 version increases the penalties for illegal activities, such as production or operation of Class II and Class III medical devices without registration certificates, with fines now ranging from 15 to 30 times the value of the goods, compared to the 10 to 20 times in the 2017 version.

2. Expanded Penalty Categories

The 2025 version includes additional penalties for the legal representatives, responsible persons, and other accountable personnel of violating entities, including confiscation of income derived from illegal activities and fines based on a percentage of such income, as well as bans on engaging in medical device production or operation.

3. Enhanced Credit Punishment

The 2025 version emphasizes the establishment of credit files for medical device registrants, filers, manufacturers, and users, increasing inspection frequency for those with poor credit records and imposing legal sanctions for dishonesty.

Angelita Hu
ChemLinked Content Manager
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