On April 8, 2025, the State Administration for Market Regulation (SAMR) of China issued the Regulation for Defective Special Equipment Recall Management (TSG 09—2025), marking a significant institutional innovation in China’s special equipment safety supervision system. The regulation aims to institutionalize defect recalls to effectively control safety risks during equipment operation and safeguard public safety and property.

This regulation applies to special equipment placed on and used in the Chinese market, including boilers, pressure vessels, elevators, lifting machinery, and special motor vehicles for industrial use. If such equipment is found to have systemic and large-scale safety hazards due to design, manufacturing, materials, or user instructions, it will be classified as “defective,” triggering a mandatory recall process.

The regulation specifies the recall responsibilities, primarily borne by manufacturers. However, sellers, importers, and users may also be obligated to act under certain circumstances. Recalls are categorized into “voluntary recalls,” initiated by enterprises themselves, and “mandatory recalls,” enforced by regulatory authorities based on risk assessments.

The recall process includes stages such as defect information collection, technical assessment, recall plan formulation and filing, public announcement, corrective action implementation, and effect evaluation. Enterprises are required to keep detailed records of the entire recall process and accept government supervision and inspection.

The regulation also establishes an information disclosure mechanism: recall information must be published through designated government platforms to ensure public right-to-know. Additionally, it mandates the creation of a defect product information management platform to systematically collect and dynamically monitor defect data.

Notably, the regulation emphasizes inter-departmental coordination and technical support. Enterprises are encouraged to work with inspection and testing institutions to evaluate risks. It also outlines penalties for failing to fulfill recall obligations or concealing defect information, including administrative fines, mandatory recall orders, and potential criminal liability in serious cases.

Overall, TSG 09—2025 fills a regulatory gap in China’s special equipment recall management system. It reflects a shift in regulatory focus from “pre-approval” to “whole-process risk management,” advancing safety supervision toward a more refined, institutionalized, and responsibility-based approach. It also helps strengthen enterprises’ quality accountability and improve the nation’s overall safety governance capacity.

I. Key Impacts

1. Global  Applicability of Recall Obligations and Full Lifecycle Responsibility
    Regardless of origin, all equipment placed on the Chinese market is subject to recall obligations if deemed defective. Manufacturers may be held accountable even after products are delivered or in use, including for design flaws or insufficient user instructions.

2. Mandatory Supervision Mechanism Increases Compliance Pressure
   Unlike the more voluntary recall frameworks common in Europe and the U.S., China’s mandatory recall mechanism allows regulators to enforce recall actions. Failure to comply may lead to penalties or loss of market access.

3. Reputation and Market Risks Rise
   All recall information must be made publicly available. Poorly handled recalls can trigger reputational crises and affect global business  operations.

4. Higher Transparency Requirements for Supply Chains
   The regulation emphasizes defect identification, traceability, corrective action, and documentation. This requires robust traceability and supply chain control, especially for European and American manufacturers with diverse components and outsourced production.

II. Response Strategies

  1.Strengthen Local Compliance Capabilities

• Establish a legal representative or liaison office in China for rapid response;

• Build legal and quality management teams familiar with Chinese laws to detect and respond to potential risks in time.

   2.Establish Defect and Recall Response Mechanisms

• Develop a centralized system for defect data collection, analysis, and evaluation;

• Create standardized recall procedures and emergency templates for quick      implementation;

• Proactively gather user feedback and incident reports to identify early warning signs.

  3. Improve Product Traceability Systems

• Digitally manage production records, component sources, and manuals;

• Promote the use of QR codes, RFID, and digital product files to enhance recall      precision and efficiency.

  4. Enhance Communication with Chinese Regulators

• Participate in industry associations and foreign enterprise cooperation platforms to      gain policy insights;

• In case of potential forced recalls, promptly engage with regulators to discuss assessments and corrective plans to maintain control.

  5. Align Product Design with Chinese Standards

• Technically adapt products to comply with China’s national special equipment standards (e.g., GB, TSG);

• Optimize product performance for China’s operational environment to prevent      failures due to incompatibility.

If you need more information, please do not hesitate to contact assistant@bestao-consulting.com Bottom of Form