Regulatory framework
Changes introduced by new recall rules

The China Food and Drug Administration (CFDA) recently issued the Provisions for Medical Device Recall. The new recall rules, which will take effect on May 1 2017, will replace the existing Interim Provisions for Medical Device Recall promulgated by the former Ministry of Health in 2011.

Regulatory framework

The new recall rules follow the basic regulatory framework for recalling devices provided in the existing rules. Recalls are divided into mandatory recalls (imposed by local food and drug administrations (FDAs)) and voluntary recalls (initiated by device manufacturers). Recalls are classified as follows, based on the severity of the product's defects:

  • Level 1 – the product has caused or may cause serious damage to health;
  • Level 2 – the product has caused or may cause non-lasting or reversible damage to health; and
  • Level 3 – the product carries only a minor risk of causing damage to health.

Under these different recall scenarios, device manufacturers are subject to different requirements for recall implementation. Device distributors and device-using hospitals must also cooperate with or assist the manufacturers during recalls.

Changes introduced by new recall rules

Compared with the existing recall rules, the new rules introduce the following significant changes.

Clarified scope of application and entity responsible for recall
The new recall rules apply to the recall of medical devices marketed in China. The holder of the product's registration licence is responsible for recalling domestic products, whereas the designated regulatory agent of the foreign device manufacturer in China is responsible for recalling imported products. If a foreign manufacturer initiates a recall outside China for a product also marketed in China, its local agent must report the recall-related information to the CFDA in a timely manner.

Expanded definition of 'defective product'
Under the existing recall rules, 'defective products' (ie, products that should be recalled) are defined as devices that pose an unreasonable risk of damaging human health or endangering human life when used under normal conditions. The new recall rules expand the existing definition by adding the following types of defective product:

  • products that do not conform to compulsory standards or to the product's technical specifications registered or filed with the CFDA;
  • products that pose an unreasonable risk due to a failure to comply with the applicable quality management rules for device manufacture and supply; and
  • products that must be recalled for other reasons.

Increased penalties for manufacturers that refuse to implement mandatory recalls
Local FDAs may identify, investigate and assess devices with potential defects and determine whether such products should be recalled at their own discretion. If device manufacturers refuse to implement such mandatory recalls, the existing recall rules allow local FDAs to impose monetary fines of three times the total value of the products that should be recalled. Conversely, the new rules refer to the penalty provisions established in Article 66 of the State Council's Regulation for the Supervision and Administration of Medical Devices (Order 650), which allow local FDAs to impose fines of up to 10 times the total value of the products that should be recalled.


The Provisions for Medical Device Recall form an important part of China's new device regulatory regime, which centres on Order 650. Device companies with product sales or local operations in China should review the new recall rules and ensure that their post-market product safety measures are in line with the more stringent regulatory requirements.

For further information on this topic please contact Katherine Wang at Ropes & Gray LLP by telephone (+86 21 6157 5200) or email (k[email protected]). The Ropes & Gray LLP website can be accessed at