Administration of state food and drug supervision and administration
No. 29
The measures for the administration of medical device recall on January 5, 2017, the state food and drug supervision and management of the administration, adopted at the meeting examined and approved, are hereby released, effective as of May 1, 2017.
Chief: jingquan
On January 25, 2017
Measures for the management of medical device recall
The first chapter is always
Article 1 with a view to strengthening the supervision and administration of medical devices, control of defects in medical device products, eliminate the potential safety hazard of medical equipment, ensure the safety of medical equipment, effective, safeguard human health and life safety, according to the regulations on the supervision and administration of medical devices, are formulated.
Article 2 the People's Republic of China has listed the supervision and administration of medical device recall and its, these measures shall apply.
Article 3 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.
Mentioned in the preceding paragraph, the medical device manufacturing enterprise refers to the domestic medical equipment product registrant or for the record, the import of foreign medical devices manufacturers designated agent in China.
Article 4 the term "defect of medical equipment products include:
(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) 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.
Article 5 of the medical device manufacturing enterprise, the main responsibility is to control and eliminate the product defects shall voluntarily to the defect product recall.
Article 6 of the medical device production enterprise shall, in accordance with the provisions of the measures to establish and perfect the system of medical device recall management, medical equipment safety related information collection, to investigate the possible defects in the product, 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 provisions of the measures to organize the implementation.
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.
Article 7 of the medical equipment management enterprise, use the unit found its management, use of medical apparatus and instruments for defective product, shall be immediately suspend the sale or use the medical apparatus and instruments, timely notify the medical device production enterprise or suppliers, and to the local province, autonomous region or municipality directly under the food and drug supervision and administration department report; Use the unit for medical institutions, shall also be at the same time to the local province, autonomous region or municipality directly under the central administrative department of public health reports.
Medical equipment management enterprise, using the local province, autonomous region or municipality directly under the food and drug supervision and administration department after receiving the report, shall timely notify the medical device manufacturing enterprise local provinces, autonomous regions and municipalities directly under the food and drug supervision and administration department.
Article 8 the recall of medical device production enterprise locus of provinces, autonomous regions and municipalities directly under the food and drug supervision and administration department is responsible for the supervision and administration of medical device recall and other provinces, autonomous regions and municipalities directly under the food and drug supervision and administration department shall cooperate well medical device recall about work within their respective administrative areas.
State food and drug supervision and management of administration supervise the work of management in medical device recall.
Article 9 the state food and drug supervision and administration of taxation and the province, autonomous region or municipality directly under the food and drug supervision and administration department shall, in accordance with the medical device recall information notification and relevant information disclosure system, and take effective ways to publish to the society information and defective product recall information, communicate relevant information to the administrative department of public health at the same level when necessary.
The second chapter medical equipment defect investigation and evaluation
Article 10 the medical device production enterprise shall establish and improve the medical equipment quality management system in accordance with the relevant provisions and medical device adverse event monitoring system, collect, record of medical equipment quality complaints or medical device adverse event information, analyze the collected information, assess and investigate the possible defects.
Medical equipment management enterprise, use units shall cooperate with medical device manufacturing enterprise to survey on medical equipment defects, and provide relevant information.
Medical device production enterprise shall, in accordance with the provisions of article 11 of medical device adverse event information in a timely manner will collect report to the food and drug supervision and administration department, the food and drug supervision and administration of medical devices adverse events or possible defects analysis and investigation, and medical equipment producing enterprises, trading enterprises, using unit shall give cooperation.
Article 12. Evaluate the defects of medical equipment products and the main contents include:
(a) whether products conform to the compulsory standards, the product technical requirements for registration or registration;
(2) in the use of medical apparatus and instruments ever occurred in the process of failure or damage;
(3) used in the existing environment will cause harm, whether to have scientific literature, research, relevant tests or validation can explain the cause of the injuries;
(4) injury involved in the region and the characteristics of the population;
(5) the extent of the damage to human body health;
(6) the probability of injuries;
(7) damage in the short term and long term consequences;
(8) other factors that may cause harm to human body.
Article 13 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 shall be determined according to the specific situation and according to the level of recall recall level and sales of medical equipment and usage, scientific design recall plan and organize their implementation.
The third chapter is voluntarily recalling
Article 14 of the medical device manufacturing enterprise in accordance with article 10 of these measures, the article 12 after the assessment of the requirements of the investigation, to determine the defect of medical equipment products, and shall immediately decided to recall, recall information to the community at the same time.
Recall the implementation 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 provinces, autonomous regions and municipalities directly under the food and drug supervision and administration department, the province, autonomous region or municipality directly under the 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.
Article 15 of the medical device manufacturing enterprise of medical device recall decision making, higher recall should in 1 days, secondary recall should be within 3 days, three levels of recall shall, within 7 days, notify the relevant medical equipment management enterprise, use the unit or inform the user.
Recall notice shall include the following contents:
(a) recall of medical equipment basic information such as name, specifications, 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.
Article 16 a medical device manufacturing enterprise of medical device recall decision making, shall be immediately to the local province, autonomous region or municipality directly under the food and drug supervision and administration department and approval or for the product registration for the record of the food and drug supervision and management departments to submit a report on the medical device recall, and within 5 working days will survey assessment and recall plans submitted to the local provinces, autonomous regions and municipalities directly under the food and drug supervision and administration department and the approval of registration or handle the record of the food and drug supervision and administration department for the record.
Medical device manufacturing enterprise locus of provinces, autonomous regions and municipalities directly under the food and drug supervision and administration department shall, within 1 working day after receiving the report on the recalls will recall the situation report the state food and drug administration bureau.
Article 17 the survey assessment report shall include the following contents:
(a) recall, in line with the actual conditions of medical apparatus and instruments, including the basic information such as name, specifications, batch;
(2) the reason of recall;
(3) survey evaluation results;
(4) recall of grading.
The recall plan shall include the following contents:
(a) medical equipment production and sales, and plans to recall the number of;
(2) the specific content of the recall measures, including the implementation of the organization, scope and time limit, etc.;
(3) the recall of information published ways and scope;
(4) the expected effect of recall;
(5) medical device recall after treatment measures.
Article 18 in case the medical device manufacturing enterprise locus of provinces, autonomous regions and municipalities directly under the food and drug supervision and administration department may recall plan submitted by the manufacturer to evaluate, think production enterprise has taken measures can effectively eliminate the product defects or control risk, it shall require the written to improve the level of recall, expanding the scope of the recall, shortening the time of recall, or change the way the recalled products processing, such as more effective measures for processing. Medical device manufacturing enterprise shall be in accordance with the requirements of the food and drug supervision and administration department to modify the recall plan and organize their implementation.
Article 19 the medical device manufacturing enterprise to change report the recall plan, shall be promptly reported to the local provinces, autonomous regions and municipalities directly under the food and drug supervision and administration department for the record.
Article 20 of the medical device manufacturing enterprise in the process of recall, shall, according to recall plan on a regular basis to the local province, autonomous region or municipality directly under the food and drug supervision and administration department submitted to recall plan implementation report.
Article 21 medical device manufacturing enterprise handling of medical device recall should have detailed records, and to the medical device manufacturing enterprise locus of provinces, autonomous regions and municipalities directly under the food and drug supervision and administration department's report, the record should be saved to the medical device registration certificate five years after the failure, the first kind of medical device recall process records shall be kept for five years. By warning, inspection, repair, back label, modify and perfect the specification, software updates, replace, destruction way to eliminate the product defects, such as can be done at the location of the products above. Need to destroy, shall be destroyed under the supervision of food and drug supervision and administration department.
Article 22 the medical device production enterprise shall, within 10 working days after completion of the recall to evaluate effect of recall, and to the local province, autonomous region or municipality directly under the food and drug supervision and administration department submit medical device recall summary appraisal report.
Article 23 medical device manufacturing enterprise location of provinces, autonomous regions and municipalities directly under the food and drug supervision and administration department shall be the date of receipt of the summary appraisal report within ten working days to review report, and to evaluate effect of recall; Think recall has not been effective to eliminate product defects or control risk, should be written request production enterprises to recall. Medical device manufacturing enterprise shall, in accordance with the requirements of the food and drug supervision and administration department to recall.
The fourth chapter shall be ordered to recall
Article 24 the food and drug supervision and administration department after survey assessment, think of medical device production enterprise shall recall defective medical devices and did not take the initiative to recall, medical device manufacturing enterprise shall be ordered to recall of medical equipment.
Ordered the recall decision can be made by medical device manufacturing enterprise location of provinces, autonomous regions and municipalities directly under the food and drug supervision and administration department, also can be dealt with by the approval of the medical device registration or for the record of the food and drug supervision and administration department. The food and drug supervision and administration department of the decision making, shall publish to the society order to recall information on its website.
Medical device manufacturing enterprise shall, in accordance with the requirements of the food and drug supervision and administration department, recall, and according to the provisions of the second paragraph of article 14 of these measures to the public product recall information.
When necessary, the food and drug supervision and administration department may require medical equipment producing enterprises, trading enterprises and use the unit immediately suspend the production, sale and use, and inform the user immediately suspend the use of the defective product.
Article 25 the food and drug supervision and administration department shall be ordered to recall decision, it shall be ordered to recall notice served on medical device manufacturing enterprise, notification includes the following contents:
(a) recall, in line with the actual conditions of medical apparatus and instruments, including the basic information such as name, specifications, batch;
(2) the reason of recall;
(3) survey evaluation results;
(4) the recall request, including the scope and time limit.
Article 26 the medical device manufacturing enterprise, after receipt of the order a recall notice shall be in accordance with the provisions of article 15 and article 16 of these measures inform medical equipment management enterprise and use of units or inform the user, recalls, submit the plan, and organize their implementation.
Article 27 of the medical device production enterprise shall, in accordance with article 19 of these measures, article 20, article 21, the provisions of article 22. Report to the food and drug supervision and administration department of the medical device recall related cases, for subsequent processing of medical device recall.
The food and drug supervision and administration department shall, according to the provisions of article 23 of the present measures for medical device manufacturing enterprise medical device recall summary appraisal report submitted for review, and evaluate the effect of recall, report the health administrative department at the same level when necessary. Through the review and evaluation, don't think recall thoroughly, has not been effectively eliminate the product defects or control the risk of product, food and drug supervision and administration department shall be written request recall to the medical device manufacturing enterprise. Medical device manufacturing enterprise shall, in accordance with the requirements of the food and drug supervision and administration department to recall.
The fifth chapter legal responsibility
Article 28 the medical device manufacturing enterprise due to violation of laws, regulations, rules and regulations listed the defect of medical apparatus and instruments, shall be given administrative punishment in accordance with the law, but the enterprise recall measures have been taken the initiative to eliminate or reduce the harmful consequences, the food and drug supervision and administration department in accordance with the provisions of the administrative punishment law of the People's Republic of China to be given a lighter or mitigated punishment. A minor illegal act, promptly puts it right and causes no harmful consequences, is not punishable.
Medical device manufacturing enterprise of medical device recall, not removed from the other shall bear legal liability in accordance with the law.
Article 29 of the medical device manufacturing enterprise in violation of the provisions of article 24 of the present measures, refused to recall of medical apparatus and instruments, according to the regulations on the supervision and administration of medical devices the provisions of article sixty-six of the processing.
Article 30 medical device manufacturing enterprise in any of the following circumstances, a warning shall be issued, shall be ordered to make corrections within a time limit and concurrently impose a fine of less than RMB 30000:
(a) in violation of the provisions of article 14 of these measures, not in a timely manner in accordance with the requirements of product recall information to the community;
(2) in violation of the provisions of article 15 of these measures, not within the prescribed period of time will be the decision of the medical device recall notifications to the medical equipment management enterprise, use the unit or inform the user;
(3) in violation of article 18 of these measures, article 23, paragraph 2, article 27 is not in accordance with the requirements for the food and drug supervision and management departments to take corrective measures or recall to the medical apparatus and instruments;
(4) in violation of the provisions of article 21 of these measures, not for the processing of medical device recall detailed records or report to the food and drug supervision and administration department.
Article 31 of the medical device manufacturing enterprise in any of the following circumstances, may issue a warning, order correction within a time limit; Overdue correction, a fine of less than RMB 30000:
(a) is not in accordance with the measures to establish the management system of the medical device recall;
(2) refused to cooperate with the food and drug supervision and administration departments to carry out the investigation;
(3) is not in accordance with the provisions of this way to submit a report on the medical device recall, investigation, assessment and planning, medical device recall recall plan and summary appraisal report;
(4) change the recall plan, submitted to the food and drug supervision and administration department for the record.
Article 32 medical equipment management enterprise, use the unit in violation of the provisions of the first paragraph of article 7 of this regulation, shall be ordered to stop the sale, use the defects in medical apparatus and instruments, and be fined between RMB 5000 yuan and 5000 yuan; Thereby causing serious consequences, revoked by the original license issuing department medical equipment business license.
Article 33 of the medical equipment management enterprise, refused to cooperate with related units used medical equipment defect investigation, refused to assist medical device manufacturing enterprise of medical device recall, a warning shall be issued, instruct deadline rectification. Overdue refuses to correct, a fine of less than 30000 RMB yuan.
Article 34 the food and drug supervision and administration department and its staff members fails to perform the supervision and administration of medical devices or abusing authority, dereliction of duty, in any of the following circumstances, shall be appointed or removed by the supervisory organ or organ according to the seriousness, the person in charge directly responsible and other directly responsible personnel to give criticism education, or give warning, demerit recording or give sanction according to law; Thereby causing serious consequences, gives demoted, dismissed or expelled disciplinary action:
(a) not according to stipulations to recall information to the community;
(2) report to the relevant departments or not according to stipulations on relevant information of recall;
(3) shall be ordered to recall the measures shall be ordered to recall;
(4) in violation of these measures as prescribed in paragraph 2 of article 23 and article 27, failed to supervise the medical device manufacturing enterprise effective implementation recalled.
The sixth chapter is attached
Article 35 a recall of medical equipment has been implanted in the body, medical device manufacturing enterprise shall consult with the medical institutions and patients, according to the different causes of recall, treatment of the patients with opinions and preparedness measures shall be adopted.
Article 36 recalled medical equipment damage to patients, the patient may demand compensation from medical device manufacturing enterprise, also can demand compensation from the medical equipment management enterprise, use the unit. Patients demand compensation from the medical equipment management enterprise, use the unit, after paying compensation, the medical equipment management enterprise, use the unit shall have the right of recourse against the responsibility of the medical device manufacturing enterprise.
Article 37 of the present measures shall enter into force as of May 1 2017. Take effect on July 1, 2011 of the "measures for the management of medical device recall (try out)" (the People's Republic of China health ministry make no. 82) shall be repealed simultaneously.
