NMPA released 2025 National Medical Device Sampling Inspection Plan

On March 26, 2025, the National Medical Products Administration (NMPA) released the "2025 National Medical Device Sampling Inspection Plan" ([2025] No. 28), setting out the framework for annual quality supervision and inspection of medical devices. The plan refines inspection procedures, clarifies reinspection rules, and strengthens management of inspection results. It covers high-risk, general, and home-use medical devices. International manufacturers selling into the Chinese market are expected to comply with the updated requirements and ensure coordination with local agents to meet inspection obligations.

Classification of Sampling Inspection Products

The 2025 National Medical Device Sampling Inspection Plan covers multiple categories of medical devices, including:

• High-risk medical devices: Such as implantable cardiac pacemakers, artificial joints, and vascular stents.
• General medical devices: Such as medical ultrasound diagnostic equipment and medical electronic thermometers.
• Home medical devices: Such as home blood glucose meters and home blood pressure monitors.

Sampling Inspection Process

• Sampling and Submission: The inspection process begins with sampling. Regulatory authorities will randomly select samples based on risk levels and market conditions and send them to designated inspection agencies. The sampling process must follow strict procedures to ensure sample representativeness and inspection fairness.
• Inspection Basis and Projects: The inspection is based on China's medical device regulations, mandatory standards, and product technical requirements. Inspection projects are determined according to product characteristics and risk levels, covering safety, effectiveness, and quality control. For example, high-frequency surgical equipment will focus on inspecting leakage current, impedance, and current-carrying capacity, while medical protective masks will focus on filtration efficiency and airflow resistance.
• Result Evaluation: Inspection results will be evaluated based on predetermined criteria. If all inspection items are qualified, the product will be deemed qualified; if there are non-compliant items, the product will be deemed non-compliant, and corresponding handling procedures will be initiated.

Response Measures for Non-compliant Products

• Reinspection and Appeal Process If a product is deemed non-compliant, the manufacturer has the right to apply for reinspection or appeal within a specified period. Reinspection applications must be submitted to the provincial drug administration department and accompanied by the relevant reinspection fees. The reinspection agency will retest the samples and issue a reinspection report. If the reinspection results remain non-compliant, the manufacturer must take further corrective measures. The appeal process applies when the manufacturer has objections to the inspection results or procedures. The manufacturer must provide sufficient evidence to support the appeal, which will be reviewed and adjudicated by the regulatory authority.
• Product Recall and Corrective Actions For non-compliant products, manufacturers must take recall measures based on the risk level. The recall may cover specific batches or all products. At the same time, manufacturers must develop a corrective action plan to ensure the problem is thoroughly resolved and submit a corrective action report for regulatory review.

Response Strategies for International Manufacturers

1. Compliance Requirements Manufacturers must ensure that products comply with Chinese regulations and standards in terms of design, production, packaging, and labeling. This may require adjustments and optimization of existing production processes and quality management systems.
2. Active Cooperation in Sampling Inspections Enterprises should regard active cooperation in sampling inspections as an obligation and a necessity for their development. Failure to cooperate without just cause will be dealt with seriously and may affect the enterprise's credit record. Enterprises should assign dedicated personnel to coordinate sampling inspections to ensure the process runs smoothly.
3. The Importance of Cooperation with Agents International manufacturers typically need to work through agents – also known as the NMPA Legal Agent – to sell products in the Chinese market. New regulations require agents to actively cooperate in sampling inspections, including submitting documents and coordinating reinspections. Manufacturers must maintain close communication with agents to ensure alignment in regulatory compliance and market response.
4. Prudent Use of Reinspection and Appeal Rights If a company disputes the inspection conclusion, it should apply for reinspection within the specified time to the provincial drug administration department where the medical device registrant, record-filer, or import product agent is located. Reinspection applications are only processed once, so companies must thoroughly assess potential issues in the inspection process to ensure sufficient grounds for reinspection. If the reinspection still does not resolve the issue, companies may also submit a written appeal application and follow the relevant provisions of the "National Medical Device Quality Random Inspection and Testing Work Procedures."

Further Information

To read the original NMPA announcement about 2025 National Medical Device Sampling Inspection Plan, please click here.

Here are the prior new about NMPA sampling inspection plan

• China medical device sampling inspection plan 2024
  

If you are a medical device manufacturer with questions about how the 2025 NMPA sampling inspection plan affects your product registration or compliance strategy for the China market, or if you require pre-audit or NMPA audit support following a failed sample inspection, please contact Cisema.

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