2026 National Medical Device Inspection Plan Results Released

Inspection Requirements

According to the notice, provincial drug regulatory departments and the National Institutes for Food and Drug Control should organize testing in accordance with the sampling inspection plan. The core bases include two categories:

●Mandatory medical device standards.

●Product technical requirements submitted during product registration or filing.

This means that sampling inspection is not only a product quality check, but also a re-confirmation of consistency with the enterprise's registration documents.

Key Change

The document adds a missing-item inspection notice mechanism. If all inspection items cannot be completed because of the following situations, the testing institution should issue a missing-item inspection notice:

●The enterprise fails to provide complete testing materials or necessary supporting items, such as dedicated fixtures, software, calibration materials, or other required tools.

●The product technical requirements are incomplete, such as missing indicators or inspection methods that cannot be operated.

The notice should be sent through the national sampling inspection information system to the provincial drug regulatory department where the enterprise is located. If the product technical requirements are incomplete, the enterprise should be urged to improve them as soon as possible and complete changes in accordance with law.

Relevant investigation and handling results should be entered into the national medical device sampling inspection information system within 30 working days after the notice is issued.

Re-inspection Process

For re-inspection issues that companies commonly care about, the document provides clearer rules:

●The re-inspection application is accepted by the provincial drug regulatory department where the enterprise is located.

●Only one re-inspection may be requested for the same inspection report.

●The re-inspection institution is selected by the provincial bureau from the designated list, and the selected institution may not refuse the task.

Institutions included in the re-inspection list must continue to have the following capabilities:

●Testing capabilities for the corresponding products and items.

●Valid legal testing qualifications, such as CMA or CNAS.

●The ability to undertake national and local re-inspection tasks.

The notice also requires public contact information to make communication easier for companies. If an enterprise still has objections and re-inspection cannot resolve the issue, it may submit a written appeal according to regulations and enter further technical or administrative review procedures.

Handling of Nonconforming Products

For products that fail to meet requirements in sampling inspection, the notice requires companies to immediately take risk control measures, such as suspending sales, recalling products, and notifying users.

Regulatory authorities will also conduct investigations in parallel:

●If case-filing conditions are met, the case should be investigated and handled in a timely manner.

●If a suspected crime is involved, the case should be transferred to judicial authorities.

Practical Impact on Companies

●Product technical requirements need to be more rigorous. Performance indicators should be complete and verifiable, inspection methods should be clear and operable, and companies should avoid requirements that are written but cannot actually be tested.

●Otherwise, technical documents may be deemed defective, and companies may even be required to change registration materials.

●The ability to cooperate with sampling inspection becomes critical. Companies should ensure they can promptly provide all required testing materials, necessary supporting equipment or conditions, and sufficient technical understanding of inspection items.

●If cooperation is insufficient, a missing-item inspection notice may be triggered.

●The quality management system must be able to respond to sudden sampling inspections, including rapid response mechanisms after nonconformities, recall and notification procedures, and communication mechanisms with regulators.

Summary

The 2026 national medical device sampling inspection plan essentially further refines details and strengthens execution on top of the existing inspection system.

Several key signals deserve attention: sampling inspection now looks not only at results, but also at the quality of technical documents; the inspection process is becoming more standardized and digitalized; and enterprises are shifting from being passive inspection targets to primary quality responsibility holders.

For companies, it is more important to clarify technical requirements, prepare inspection conditions, and operate the quality system smoothly in advance than to respond after problems occur.