China Issues Recall Regulation for Defective Special Equipment

On 8 April 2025, the State Administration for Market Regulation (the “SAMR”) issued the Regulation for Defective Special Equipment Recall Management (the “Recall Regulation”), which will come into force on 1 August 2025. This regulation establishes a comprehensive recall mechanism for addressing systemic safety risks in special equipment, filling a long-standing legislative gap under the Law of the People's Republic of China on Special Equipment Safety (the “Special Equipment Safety Law”), effective since 2014.

The “special equipment” governed by the Special Equipment Safety Law and the Recall Regulation is listed in the Catalogue of Special Equipment approved and issued by the State Council, including boilers, pressure vessels, pressure pipes, elevators, etc. While the Special Equipment Safety Law mandates producers to recall special equipment with serial defects due to production reasons that endanger safety, the absence of procedural frameworks for recalls of special equipment led to uncertainties in practice. The Recall Regulation now clarifies recall procedures, outlines compliance requirements for enterprises, and defines supervisory roles of relevant authorities, establishing a more robust mechanism for recalls of special equipment.

Key Points

Definition of Serial Defect

The Special Equipment Safety Law mandates that “in case of serial defects of special equipment due to production reasons that endanger safety, the special equipment producers shall immediately cease production and proactively initiate recalls of the equipment.” However, there is no definition of “serial defect” under the Special Equipment Safety Law.

The Recall Regulation now clarifies that a “serial defect” refers to a condition that is common to special equipment of the same batch, model, or category – arising from design, manufacturing, installation, modification, repair, or other causes – that either fails to comply with safety technical regulations and relevant standards intended to protect personal and property safety or otherwise poses unreasonable danger to personal and property safety.

The Recall Regulation explicitly ​​incorporates installation, modification, and repair within the scope of “production reasons” under the Special Equipment Safety Law. Furthermore, even special equipment that meets safety standards may still be deemed defective if it presents any “unreasonable danger” to personal and property safety.

Scope of Recall Obligation and Obligor

The Recall Regulation extends the scope of recall obligation beyond the special equipment itself to include safety accessories, materials, spare parts, protection devices, instruments, and components, etc. that are not originally shipped with the special equipment. Accordingly, the obliged “producer” is extended to include enterprises engaged in the design, manufacturing, installation, modification, and repair of special equipment and related parts. Besides, the Recall Regulation also makes it clear that importers of foreign special equipment for sale in China are also considered producers and must comply with recall requirements. ​This expansion implies that a broader range of enterprises involved in the supply chain of special equipment will be held accountable under the Recall Regulation.

Recall Process

The Recall Regulation establishes a structured recall process, including:

Report and Analysis of Defect Information

The Recall Regulation imposes an obligation on a number of subjects to report to the in-charge authority defect information of special equipment upon discovery of potential serial defect, including inspection and testing organisations, market regulators, and equipment users. In this regard, the annexes to the Recall Regulation provide reporting templates for each subject. The information to be reported includes basic identification, product characteristics, safety hazards, and potential harm etc. Interestingly, as mentioned above, the obligation to report potential serial defects is also extended to mere equipment users, however, no negative legal consequences are provided for not doing so under the Recall Regulation.

It is worth noting that special attention is given to overseas recalls. If special equipment manufactured in China is recalled abroad, or if foreign-made special equipment is recalled in accordance with laws and regulations of the production location, such information shall also be reported by relevant entities.

All such defect information shall be reported to the provincial Administration for Market Regulation, which will then report to the SAMR for further analysis.

The Recall Regulation does not provide a template for the producer to report defect information of special equipment upon discovery of potential serial defect. Instead, it requires the producers to conduct investigations promptly and implement recalls if the investigations conclude that there is any serial defect, and such recall shall be reported to the SAMR within 5 working days upon confirmation of any serial defect.

Investigation and Determination of Defect

The producers of special equipment are primarily responsible for investigating serial defects. Upon discovery of any potential serial defect, the producers shall conduct investigations promptly. If the SAMR identifies any potential serial defect before a producer does, it may issue a written notification and require the producer to investigate and submit results by a specified deadline.

Moreover, the SAMR can also conduct independent defect investigations in any of the following cases:

• The producer fails to carry out defect investigation and analysis as required and notified by the SAMR;
• The investigation result is insufficient to prove there is no existence of any serial defect;
• The serial defect(s) of the special equipment may cause serious consequences or have a wide influence.

To conduct such defect investigations, the SAMR may take the following measures:

• Interview responsible and relevant personnel of the producers, business operators and users of special equipment;
• Conduct on-site inspections, review and copy relevant documentation and records of the producers, business operators, users, and inspection and testing organisations of special equipment;
• Engage technical agencies to conduct defect engineering analysis tests;
• Engage technical experts to conduct technical analyses and risk assessments;
• Take other measures provided in other laws and regulations such as administrative interview.

Proactive Recalls and Ordered Recalls

Recalls may be initiated voluntarily by the producers (proactive recalls) or mandated by the SAMR (ordered recalls). If a producer fails to initiate a recall after notification by the SAMR or fails to submit a written objection within 15 working days, or if, after handling the objection, it is determined that there exists any serial defect, the SAMR may order a recall, and the producer shall comply immediately. Noncompliance may result in administrative penalties under the Special Equipment Safety Law, including suspension of production, fines, or revocation of licences.

Implementation of Recall

According to the Recall Regulation, the producers shall establish an effective special equipment recall management system, and this system shall meet the following legal compliance requirements:

• Recall Notification: The producers shall immediately cease production, sales, or imports, with notification to relevant business operators and users.
• Recall Plan Submission: The producers shall submit recall plan to the SAMR within 5 working days of defect confirmation or recall order. Any modification to the recall plan shall be reported to the SAMR in a timely manner.
• Recall News Publishment: The producers shall publish recall news within 5 working days from the date of the publishment of recall notice by the SAMR in a manner that is easily accessible to the public.
• Accept Public Inquiry: The producers shall accept public inquiry on the recall information published.
• Eliminate Defects: The producers shall take recall measures including offering repairs, modifications, replacements, refunds or other measures at their own expense to eliminate the defects. If it is discovered that the scope of the initial recall is not accurate or the initial recall failed to effectively eliminate serial defects, the producers shall re-implement the recall.
• Reporting and Documentation: The producers shall submit progress reports every 3 months and a final report within 15 working days of completing the recall. Records of the recall must be retained for at least 10 years.

Liability

Under China’s current legal framework, the producers and sellers of special equipment with serial defects face both civil liabilities and administrative penalties, including:

• Civil Liabilities: According to the Civil Code, if a product defect endangers personal or property safety, the aggrieved party may claim tort liability against the producers and the sellers to bear tortious liability, including demands to ​​cease infringement, remove hazards, or eliminate dangers, etc. Once a defect is discovered after the product enters circulation, the producers and the sellers are legally obligated to immediately implement remedial measures​​ such as halting sales, issuing warnings, or initiating recalls, etc. Failure to take prompt and effective remedial actions that result in aggravated harm may subject them to liability for the expanded damages​​. Additionally, ​​all necessary expenses arising from the recall (e.g., transportation and repair costs) must be borne by the producers and sellers.
• Punitive Damages: In addition to the above, under the Civil Code, if any producer or seller knowingly produces or sells defective products or fails to take effective remedial measures, causing death or serious damage to the health of another person, the infringed party shall be entitled to claim appropriate punitive damages.
• Administrative Penalties: The Special Equipment Safety Law imposes penalties on manufacturers who knowingly continue production or fail to recall equipment with serial defects. Regulatory authorities may ​​order corrections, compel production cessation, impose fines, or revoke licences in severe cases​​.

The Recall Regulation does not modify the above legal consequences under the Civil Code or the Special Equipment Safety Law, instead, the Recall Regulation makes it clear that the producers of special equipment with serial defects shall not be exempted from such liabilities or penalties, even if they have fulfilled recall obligations under the Recall Regulation.

Conclusion

The Recall Regulation marks a significant step forward in the regulatory oversight of special equipment in China. By formally establishing the recall system, regulators aim to enhance accountability among producers and encourage proactive quality assurance. Producers, importers, and users of special equipment are strongly advised to establish and maintain robust recall management systems to ensure compliance and mitigate legal risk.

The full text of the Recall Regulation (Chinese only) ​​is available at this link.