In order to strengthen the supervision and management of medical device recall and effectively promote the implementation of the main responsibility of enterprise recall, according to the Regulations on the Supervision and Administration of Medical Devices (hereinafter referred to as the Regulations), the State Food and Drug Administration has formulated and promulgated the Measures for the Administration of Medical Device Recall (hereinafter referred to as the Measures). The Measures will be implemented on May 1, 2017, and the relevant contents are now interpreted as follows:
I. Why should the Measures be revised?
As a special commodity, medical devices play an important and irreplaceable role in improving people’s health and quality of life. The safety and effectiveness of medical devices is directly related to people’s health and social harmony and stability, and is a major livelihood and public safety issue. If the listed products are defective and cannot be recalled and controlled in time, it may endanger the health and safety of consumers. Therefore, the establishment and implementation of the recall system of medical device products by the state plays an important role in controlling the risks of defective medical device products after listing, eliminating potential safety hazards of devices and protecting public safety. The practice in other countries and other fields also shows that the recall system is a powerful guarantee to safeguard the safety and rights of consumers. Based on the importance of the medical device recall system, in order to strengthen the supervision and management of the recall-related work, in 2011, the Ministry of Health of the People’s Republic of China issued the Administrative Measures for Medical Device Recall (Trial) (Order No.82), which came into effect on July 1, 2011. The publication and implementation of the "Measures (for Trial Implementation)" provides legal guarantee for timely controlling the risks of medical devices after listing and protecting the safety of public equipment. The implementation of medical device recall system is not only an effective method to control the risk of medical devices, promote the progress of production technology and improve product design, but also an important measure to promote production enterprises to improve product quality awareness and standardize market competition order.
The newly revised Regulations in 2014 included the recall system, which also became a highlight of the new version of the Regulations. In order to further strengthen the management of medical device recall, according to the requirements of the Regulations, on the basis of full investigation of recall systems at home and abroad in the early stage, combined with China’s national conditions and practice, and after soliciting opinions from all parties, the "Measures (Trial)" version was repeatedly discussed and revised, and the "Measures" was revised.
2. What are the main contents stipulated in the Measures?
(1) What is the definition of medical device recall?
The recall of medical devices mentioned in the Measures refers to the actions taken by medical device manufacturers to deal with the defective medical device products of a certain category, model or batch that they have sold on the market according to the prescribed procedures, such as warning, inspection, repair, re-labeling, modification and improvement of instructions, software update, replacement, recovery and destruction.
(2) What are the recall obligations of medical device manufacturers?
Medical device manufacturers are responsible for the quality and safety of their medical devices. We should establish and improve the management system of medical device recall in accordance with the provisions of the Measures, collect information related to the safety of medical devices, investigate and evaluate possible defective products, and recall defective products in time.
The agent designated by the overseas manufacturer of imported medical devices in China shall report the relevant information about the recall of medical devices only abroad to china food and drug administration in time; Where the recall is carried out in China, the designated agent in China shall organize the implementation in accordance with the provisions of the Measures.
(3) What are the recall obligations of medical device enterprises and users?
Medical device enterprises and users shall actively assist medical device manufacturers to investigate and evaluate defective products, actively cooperate with the manufacturers to fulfill the recall obligations, timely convey and feedback the recall information of medical devices according to the recall plan, and control and recover the defective products.
(4) What are the categories of medical device recalls?
According to the different starting conditions of medical device recall, medical device recall can be divided into active recall and ordered recall.
Voluntary recall is a legal obligation of medical device manufacturers to evaluate the quality of medical device products according to relevant requirements or information such as product adverse events, and to determine the defects of medical device products, which are voluntarily implemented by the manufacturers. Ordered recall refers to the recall of medical devices by the food and drug supervision and administration department after investigation and evaluation, which believes that medical device manufacturers should recall defective medical device products without taking the initiative to recall them. In practice, enterprises should take the initiative to recall, supplemented by government departments ordering recalls.
(5) What are the levels of medical device recall?
According to the severity of medical device defects, medical device recalls are divided into:
(1) First-class recall: the use of the medical device may or has caused serious health hazards;
(2) Secondary recall: the use of the medical device may or has caused temporary or reversible health hazards;
(3) Three-level recall: it is less likely that the medical device will cause harm, but it still needs to be recalled.
Medical device manufacturers should determine the recall level according to the specific situation and scientifically design the recall plan and organize its implementation according to the recall level and the sales and use of medical devices.
If a medical device manufacturer makes a decision on medical device recall, the first-level recall shall be within 1 day, the second-level recall shall be within 3 days, and the third-level recall shall be within 7 days, and the relevant medical device business enterprises, users or users shall be notified.
The recall notice shall at least include the following contents:
(1) Recall the basic information such as the name and batch number of medical devices;
(2) the reasons for the recall;
(3) requirements for recall, such as immediately suspending the sale and use of the product, forwarding the recall notice to relevant operating enterprises or users, etc.;
(four) the way to deal with the recalled medical devices.
(six) how to punish medical device manufacturers for refusing to recall medical devices?
Medical device manufacturing enterprises, in violation of the provisions of Article 24 of the Measures, refuse to recall medical devices. According to the provisions of Article 66 of the Regulations, the food and drug supervision and administration department of the people’s government at or above the county level shall order them to make corrections and confiscate the medical devices illegally produced, operated or used; If the value of medical devices illegally produced, operated or used is less than 10,000 yuan, a fine ranging from 20,000 yuan to 50,000 yuan shall be imposed; If the value of the goods is more than 10,000 yuan, a fine of more than 5 times and less than 10 times the value of the goods shall be imposed; If the circumstances are serious, it shall be ordered to stop production and business until the original issuing department revokes the registration certificate, production license and business license of medical devices.
(seven) how to punish the medical device operating enterprises and users who refuse to cooperate with the medical device manufacturing enterprises to fulfill the recall responsibility?
Medical device enterprises and users who refuse to cooperate with the investigation of medical device defects or assist medical device manufacturers in recalling medical devices shall be given a warning and ordered to make corrections within a time limit; Those who refuse to make corrections within the time limit shall be fined up to 30,000 yuan.
3. What are the amendments to the Measures?
The Measures include six chapters and thirty-seven articles, including general principles, investigation and evaluation of medical device defects, voluntary recall, ordered recall, legal liability and supplementary provisions. The revision of the Measures retains the framework and main contents of the Measures (for Trial Implementation). According to the Regulations, the scope of recall and individual operating procedures are supplemented and adjusted, the main responsibility and legal responsibility of production enterprises are strengthened, and the punishment for violations of laws and regulations is intensified. The main amendments include:
(a) the implementation of the main responsibility of medical device recall. It is clear that the registrants or filers of domestic medical device products and the agents designated by overseas manufacturers of imported medical devices in China are the main bodies of medical device recall.
(2) The scope of application has been clarified. The Measures (for Trial Implementation) stipulates that "these Measures shall apply to the recall of medical devices sold in People’s Republic of China (PRC) and their supervision and management", and the Measures shall be amended as "the recall of listed medical devices in People’s Republic of China (PRC) and its supervision and management", which clarifies that all medical device products registered in China shall be implemented or reported in accordance with the requirements of these Measures.
(3) Adjusting the scope of defective products. The Measures (Trial) stipulates that "the recall of medical devices mentioned in these Measures refers to the behavior of medical device manufacturers to eliminate defects by warning, inspecting, repairing, relabeling, modifying and perfecting the instructions, upgrading the software, replacing, recalling and destroying a certain category, model or batch of products that have been sold in the market according to the prescribed procedures", "The defects mentioned in these Measures", It means that medical devices have unreasonable risks that may endanger human health and life safety under normal use, that is, the scope of recall is medical devices that have unreasonable risks that may endanger human health and life safety under normal use. According to the newly revised Regulations, the Measures expand the scope of defective products to "(1) products with unreasonable risks that may endanger human health and life safety under normal use; (two) products that do not meet the mandatory standards and the technical requirements of registered or filed products; (three) products that do not meet the relevant provisions of the quality management of medical device production and circulation, which may lead to unreasonable risks; (4) Other products that need to be recalled ".
(4) The content of defect assessment has been added. In response to the revision to expand the scope of defective products, the item "Does the product meet the mandatory standards, registered or filed product technical requirements" has been added in the main content of evaluating the defects of medical devices.
(5) The regulatory authorities that supervise the destruction of recalled products have been adjusted. The "Measures (Trial)" stipulates that "if it needs to be destroyed, it shall be destroyed under the supervision of the drug supervision and administration department at the place of destruction". But in practice, this method is not conducive to practical operation. At the same time, with the rapid development of information technology, the diversification of supervision methods is the general trend. Therefore, the "Measures" were amended as "Those that need to be destroyed shall be destroyed under the supervision of the food and drug supervision and administration department."
(6) Adjusted the requirements for notification of recall information. The "Measures (Trial)" stipulates that "the drug supervision and administration department shall review the report within 10 days from the date of receiving the summary report and evaluate the recall effect. The conclusion of the review and evaluation shall be notified to the medical device manufacturer in written form and copied to the health administrative department at the same level ". In practice, it is difficult to inform medical device manufacturers and health administrative departments at the same level in written form of review and evaluation conclusions. Therefore, the "Measures" cancel the requirement of notifying production enterprises in written form, and change the information notification to the health administrative department to "notify relevant information to the health administrative department at the same level when necessary".