China has issued the "Management Measures for Medical Device Recall (Trial)"

The recall of defective medical devices is an international practice that plays an important role in ensuring the safety of public use of devices, and also reflects the concept that medical device manufacturers are the first responsible person for product quality. In order to gradually establish and improve a medical device recall system that is in line with China's regulatory reality, the "Medical Device Recall Management Measures (Trial)" (hereinafter referred to as the "Measures") has been introduced recently and officially implemented from July 1st.

The Measures consist of six chapters and thirty-eight articles, which provide specific provisions for the management of medical device recalls in terms of regulatory system, grading and classification of recalls, legal responsibilities, and other aspects. The specific features include:

One is to align with international practices on core issues. The core issue in formulating this "Measures" is what kind of medical devices need to be recalled. The Measures draw on the definitions of defective product recalls from the United States, the European Union, and others, The products that need to be recalled are limited: "The medical device recall referred to in these measures refers to the behavior of medical device manufacturers, in accordance with the prescribed procedures, to eliminate defects in a certain category, model, or batch of products that have been marketed and sold by warning, inspection, repair, re labeling, modification and improvement of instructions, software upgrade, replacement, retrieval, destruction, and other methods

The second is to learn from the drug recall system and establish the main system for medical device recall management from three aspects: content framework, regulatory system, recall grading and classification, and legal responsibility. In terms of the regulatory system for medical device recalls, Article 8 of the "Measures" specifically stipulates that the regulatory system for medical device recalls is mainly composed of provincial food and drug regulatory bureaus (drug regulatory bureaus). In terms of the grading and classification of recalls, Article 13 of the "Measures" divides recalls into three levels based on the severity of medical device defects, from high to low; At the same time, the recall of medical devices is divided into two categories: active recall and ordered recall, and two chapters, "active recall" and "ordered recall", are established to respectively specify the implementation procedures and supervision and management of medical devices. In terms of legal liability, the "Measures" impose penalties on those who fail to fulfill their statutory recall obligations.

The third is to make specialized regulations based on the characteristics of medical device supervision. Medical devices involve a wide range of disciplines, a wide variety of categories, and a high degree of technical complexity. The "Measures" clearly define the definition of medical device recall and the handling methods of recalled products. In the definition of "medical device recall", in addition to emphasizing the existence of defects in the product, it also highlights the recall of medical devices. Not only can the product be recalled, but also methods such as warning, inspection, repair, re labeling, manual modification, software upgrade, replacement, etc. can be used to eliminate defects; Detailed regulations have been established for the product handling measures after the recall of medical devices. At the same time, the Measures clarify the content of the recall notice. After making a recall decision, medical device manufacturers should promptly notify all operating enterprises, user units, or inform users to control the product to prevent further injury incidents. In order to increase operability, the Measures stipulate the specific content of recall notices.