Medical network - on February 9, 2014 on June 1, the newly revised regulations on the supervision and administration of medical devices was promulgated, puts forward new requirements for medical device recall. Administration of state food and drug supervision and management of the organization of the original "medical device recall management approach (trial)" modified, form the "measures for the management of medical device recall" (hereinafter referred to as the "method"), on January 5, 2017, the methods adopted by the state food and drug supervision and management of administration meeting examined and approved, shall take effect on May 1, 2017.
The modifications mainly involves the following contents:
One is implement the main responsibility of medical device recall. Clear medical device products within the territory of registrant or for the record, the import of foreign medical devices manufacturers designated agent in China is to implement the main responsibility of medical device recall.
The second is clear defects in medical apparatus and instruments product range. According to the regulations on the supervision and administration of medical devices article 52 "found that the medical device manufacturing enterprise production of medical equipment do not conform to the compulsory standards, the product technical requirements for registration or registration or other defects, shall voluntarily recalled products", "method" lists the range of medical device recall, include: (1) under normal use may endanger human body health and life safety of unreasonable risk products; (2) do not conform to the compulsory standards, the product technical requirements for registration or registration of products; (3) does not conform to the medical equipment quality control in the production and operation of the relevant provisions of the unreasonable cause there may be a risk of products; (4) other products need to be recalled.
Three is to strengthen the medical device recall information disclosure requirements. Refine the recall of the medical device manufacturing enterprise information delivery obligation, recall provisions level, medical device recall notice shall be in the state food and drug administration bureau website and posted on the central major media; Implementation of secondary and tertiary recall, medical device recall notice shall, in the provincial food and drug supervision and administration department, the provincial food recall notice shall be issued by the pharmaceutical supervisory and administrative department website and the state food and drug supervision and administration bureau website links. Decided to order the food and drug regulatory department, recall by the food and drug supervision and administration department of the decision making on its web site to the public shall be ordered to recall information, and demanded that the medical device manufacturing enterprise by the regulation to the public product recall information.
Four is to further strengthen the food and drug regulatory oversight responsibility. Clear in addition to the medical device manufacturing enterprise is located outside the provincial food and drug supervision and administration department, or for approval of the medical device registration for the record of the food and drug supervision and administration department may also be ordered to recall decision. At the same time, the refinement of the food and drug supervision and administration department and its staff members fails to perform the duties or abuse of power, and provisions of the corresponding penalties.
In addition, "method" has been clear about the medical device production enterprise shall establish and improve the management of medical device recall recall of the system, to strengthen the medical device manufacturing enterprise reporting obligations, improve the food and drug supervision and administration department of information reporting requirements, etc.
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To strengthen the supervision and administration of medical device recall and improve enterprise recall implementation main body responsibility, according to the regulations on the supervision and administration of medical devices (hereinafter referred to as the regulations), the state food and drug supervision administration enacted the "measures for the management of medical device recall" (hereinafter referred to as the "method"). This "method" will come into force on May 1, 2017, will now read the content is as follows:
A, "method" : why do you want to change?
Medical apparatus and instruments as a special commodity, in improving people's health level and improve people's lives, play an important irreplaceable role. Medical equipment is safe and effective, is directly related to people's health and social harmony and stability, is important of people's livelihood and public safety problems. Listed if the products have defects and can not be recalled in time and try to control, it may endanger the health and safety of consumers. Countries, therefore, to establish and implement medical equipment product recall system, to control the listed defects in risk of product of medical apparatus and instruments, after eliminating equipment safe hidden trouble, plays an important role to protect the public safety. In other countries and other areas of practice also shows that the recall system is the powerful guarantee of the rights and interests of consumer safety. Based on the importance of medical device recall system, in order to strengthen the supervision and management of the recall of related work, in 2011, the ministry of health of the People's Republic of China issued a "medical device recall management approach (trial)" (the 82th order) (hereinafter referred to as the "method (try out)"), and effective as of July 1, 2011. "Method (trial) version of the release and implementation, for the timely control of the risk of medical equipment, with machinery to protect the public safety provides legal protection. Medical device recall system, not only is to control the risk of medical instruments, promote the progress of production technology, an effective way to improve the product design, and promote manufacturing enterprises to improve product quality consciousness, standardize the order of market competition of the important measures.
In 2014 the newly revised regulations will include the recall system, has become a major highlight of the new regulations. To further strengthen the management of medical device recall, according to the requirements, the regulations in the prophase of recall system at home and abroad on the basis of investigation and combining with China's national conditions and practice, the opinions from all sides, the "method (trial) version of the discussed repeatedly modification, revision completed this" method ".
Second, the main contents of "method" regulation what?
(a) what is the definition of a medical device recall?
"Method", the term "medical device recall, refers to the medical device manufacturing enterprise according to the procedures prescribed by the a particular category, type of sales already on the market or batch of defective products, medical devices take warning, inspection, repair, back label, modify and perfect the specification, software updates, replacement, in the form of recall, destroy and treatment behavior.
(2) medical device manufacturing enterprise of recalled obligation is what?
Is the medical device manufacturing enterprise in the production of medical equipment quality and safety is responsible for the main body. Shall, in accordance with the provisions of the "method" to establish and perfect the system of medical device recall management, medical equipment safety related information collection, to investigate the possible defects products, assessment, defect product recall in a timely manner.
Import overseas manufacturers of medical equipment in China designated agent shall only outside the information about the implementation of medical device recall timely report the state food and drug administration bureau; Recall involving in the territory of the People's Republic of China designated agent shall, in accordance with the "way" regulation, organize the implementation.
(3) the medical equipment management enterprise, unit using the recall of obligation is what?
Medical equipment management enterprise, using unit shall actively assist the medical device manufacturing enterprise for defective product investigation, evaluation, actively cooperate with production enterprises to perform the duty of recall according to the recall plan timely convey, medical device recall information feedback, control and recovery of the defective product.
(4) medical device recall several class?
According to the start of the medical device recall, medical device recall is divided into voluntary recall and ordered a recall.
Voluntary recall is the medical device production enterprise shall, in accordance with the relevant requirements or according to the product information such as adverse events to the production of medical equipment products quality assessment, to determine the defect of medical equipment products, by the production enterprise active implementation of recall, is the legal obligation of the enterprise. Ordered a recall that the food and drug supervision and administration department by survey assessment, think of medical device production enterprise shall recall defective medical devices without active recall, order the implementation of the medical device manufacturing enterprise of medical device recall. In practice, should give priority to with enterprise is voluntarily recalling, government departments shall be ordered to recall is complementary.
(5) medical device recall a few level?
According to the severity of the medical equipment defects, medical device recall is divided into:
(a) level of recall: use the medical devices may or has caused serious health hazard;
(2) secondary recall: use the medical devices may or has caused a temporary and reversible health hazards;
(3) 3 recalled: use the medical devices are less likely to cause harm but still need to be recalled.
Medical device manufacturing enterprise should be based on specific circumstances to determine the level of recall and according to the level of recall and sales of medical equipment and usage, scientific design recall plan and organize their implementation.
Medical device manufacturing enterprise, medical device recall decision level should be in 1 days, recall secondary recall should be within 3 days, level 3 should recall within 7 days, inform the relevant medical equipment management enterprise, use the unit or inform the user.
Recall notices shall at least include the following contents:
(a) recall medical equipment basic information such as name, batch;
(2) the cause of the recall;
(3) the requirements of recall, such as immediately suspend the sale and use of the product, will recall notice forwarded to the related business enterprise or the organization using;
(4) to recall the treatment of medical apparatus and instruments.
(6) refused to medical device manufacturing enterprise of medical device recall how to punish?
Medical device manufacturing enterprise in violation of the provisions of article 24 of the "method", refused to recall of medical apparatus and instruments, according to the provisions of article sixty-six of the regulations, by the people's governments at or above the county level to the food and drug supervision and administration department shall be ordered to correct, confiscate the illegal production, operation or use of medical apparatus and instruments; Illegal production, operation or use of medical value of less than 10000 yuan, and be fined between RMB 20000 yuan and 20000 yuan; Value of 10000 yuan of above, and be fined value 5 times more than 10 times the; If the circumstances are serious, order to suspend production or business operation, until revoked by the original license issuing department registration certificate of medical equipment, medical equipment production license, medical equipment business licenses.
(7) medical equipment management enterprise, use the unit refused to cooperate with medical device manufacturing enterprise to fulfill its responsibility to recall how to punish?
Medical equipment management enterprise, refused to cooperate with related units used medical equipment defect investigation, refused to help recalling medical apparatus and instruments, medical device manufacturing enterprise may issue a warning, order correction within a time limit; Overdue refuses to correct, a fine of less than 30000 RMB yuan.
What are the change point three, "method"?
The methods include general provisions, medical equipment defect investigation and evaluation, is voluntarily recalling, shall be ordered to recall, legal responsibility and supplementary provisions article 37 in chapter six. Revision of the "method", "method (try out)" retained the framework and main content, according to the regulations, focus on the scope of the recall and complementary and adjusted the individual operating procedures, enhanced production enterprise's main body responsibility and legal responsibility, increasing the penalties for violation behavior, modify the content mainly includes:
(a) implement the main responsibility of medical device recall. Registrant or clear in medical devices for the record, import overseas manufacturers of medical equipment in China designated agent is the main part of the implementation of medical device recall.
(2) has been clear about the scope of application. "Method (try out)" regulation, "this method is suitable for sale in the territory of the People's Republic of China medical device recall supervision and management", "method" is amended as "the territory of the People's Republic of China are on the market of medical device recall and its supervision and management", made clear all registered medical device products in our country, recalled in domestic or overseas, should be implemented according to the requirements of this "method" or report.
(3) to adjust the scope of the defective product. "Method (try out)" regulation "medical device recall, as mentioned in the present measures refers to the medical device manufacturing enterprise according to the procedures prescribed by the listed defects in a particular category, type of sales or batches of product, take warning, inspection, repair, back label, modify and perfect the specification, software upgrades, replaced, and ways to eliminate defects such as back, destroy behavior", "" defect" as mentioned in the present measures, refers to the medical equipment in normal use may endanger human health and life safety of unreasonable risk ", namely the recall is exist in normal use may endanger human health and life safety risk of unreasonable medical apparatus and instruments. The methods according to the new revision of the regulations, to expand the scope of the defective product for "(a) under normal use may endanger human health and life safety of unreasonable risk products; (2) do not conform to the compulsory standards, the product technical requirements for registration or registration of products; (3) is not in conformity with the quality management for medical equipment production, circulation unreasonable regulations lead to possible risk products; (4) other products need to be recalled".
(4) increase the defect evaluation content. Corresponding modifications, to enlarge the range of defective product to evaluate the defects of medical devices in the main content, increase the "whether products conform to the compulsory standards, the product technical requirements for registration or registration".
(5) adjust the regulatory supervision of recalled products destroyed. "Method (try out)" regulation "need to be destroyed, shall be destroyed under the supervision of destruction to pharmaceutical supervisory and administrative department". But in practice, this way is not conducive to the actual operation. At the same time, in the current information technology, the diversification of supervision mode is the trend of The Times. Therefore, "method" changed to "need to destroy, shall be destroyed under the supervision of food and drug supervision and administration department."
(6) to adjust the recall of information reporting requirements. "Method (try out)" regulation "the pharmaceutical supervisory and administrative department shall, within 10 days from the date of receiving the summary report to review report, and evaluate the effect of recall. Review and evaluation conclusion medical device manufacturing enterprise shall be notified in written form and sent to the administrative department of public health at the same level". In practice, review and evaluation conclusion written notice to the medical device manufacturing enterprise and notify the health administrative department at the same level requirement is difficult to operate. Therefore, "method" cancel the written notice to the requirements of manufacturing enterprises and amend the information reported to the administrative department for health to "communicate relevant information to the administrative department of public health at the same level when necessary". |
