Medical Device Recall Management Measures" is now published

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"Medical Device Recall Management Measures" has been implemented since May 1, 2017

The State Food and Drug Administration Decree No. 29, "Medical Device Recall Management Measures" has been considered and adopted by the State Food and Drug Administration Bureau meeting on January 5, 2017, the "Medical Device Recall Management Measures" since May 1, 2017 shall come into force. The following China Examiner shares the details of the Measures for the Administration of Recall of Medical Devices as follows:

Decree of the State Food and Drug Administration

No. 29

The Measures for the Administration of Recall of Medical Devices have been deliberated and adopted by the Board Meeting of the State Food and Drug Administration on January 5, 2017, and are hereby promulgated, and shall come into force from May 1, 2017 onwards. .

Director: Bi Jingquan

January 25, 2017

Measures for the Administration of Recall of Medical Devices

Chapter I General Provisions

Article 1 In order to strengthen the supervision and management of medical devices, control the existence of defective medical device products, to eliminate the hidden dangers of the safety of medical devices, to ensure that the medical devices are safe, effective, and to protect human health and life safety

Article II of the Chinese people **** and the country has been listed on the recall of medical devices and its supervision and management, the application of these measures.

Article 3 of these measures referred to in the recall of medical devices, refers to the medical device manufacturers in accordance with the prescribed procedures for its has been marketed and sold in a certain category, model or batch of defective medical device products, to take warning, inspection, repair, re-labeling, modification and improvement of the instructions, software updates, replacement, recovery, destruction and other ways to deal with the behavior.

The preceding paragraph of the medical device manufacturer, refers to the territory of the medical device product registrant or filer, imported medical devices, foreign manufacturers in China designated agent.

Article 4 of the Measures referred to in the existence of defective medical device products include:

(a) the normal use of the product there may be an unreasonable risk of endangering human health and safety of life;

(b) does not comply with the mandatory standards, registered or filed by the technical requirements of the product products;

(c) does not comply with the relevant provisions of the medical device production, operation and quality management of the product. (C) does not meet the medical device production, operation and quality management of the relevant provisions of the product may be unreasonable risk;

(D) other products need to be recalled.

Article V medical device manufacturers are responsible for controlling and eliminating product defects, should take the initiative to implement the recall of defective products.

Article 6 medical device manufacturers shall establish and improve the medical device recall management system in accordance with the provisions of these measures, collect medical device safety-related information, investigate and assess possible defective products, and recall defective products in a timely manner.

The foreign manufacturers of imported medical devices in China designated agent shall be implemented only outside the medical device recall information reported to the State Food and Drug Administration in a timely manner; where the implementation of the recall involves the implementation of the territory, the designated agent in China shall be in accordance with the provisions of this approach to the implementation of the organization.

Medical device operators, the use of units should actively assist the medical device manufacturer to investigate the defective products, assessment, take the initiative to cooperate with the manufacturer to fulfill the recall obligations, in accordance with the recall plan to convey timely, feedback medical device recall information, control and recovery of defective products.

Article 7 of the medical device business enterprises, the use of medical devices found in their operation, the use of medical devices may be defective products, should immediately suspend the sale or use of the medical device, and promptly notify the medical device manufacturer or supplier, and to the local provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration report; the use of the unit of medical institutions, but also to the local province, Autonomous regions, municipalities directly under the Central Health Administration report.

Medical device business enterprises, the use of units in the local provinces, autonomous regions, municipalities directly under the central food and drug supervision and management department received the report, it should be promptly notified to the medical device manufacturer of the local provinces, autonomous regions, municipalities directly under the central food and drug supervision and management department.

Article 8 of the recall of medical devices manufacturer where the province, autonomous regions, municipalities directly under the Central Food and Drug Administration is responsible for the supervision and management of medical device recall, other provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration shall cooperate to do a good job in the administrative region of the recall of medical devices related work.

The State Food and Drug Administration to supervise the national medical device recall management.

Article IX of the State Food and Drug Administration and the provinces, autonomous regions and municipalities directly under the Central Food and Drug Administration shall, in accordance with the medical device recall information notification and information disclosure system, to take effective means to the community to publish information on defective products and recall information, if necessary, to the same level of the health administrative department notification of relevant information.

The second chapter of the investigation and evaluation of medical device defects

Article 10 of the medical device manufacturer shall, in accordance with the provisions of the establishment of a sound quality management system for medical devices and medical device adverse event monitoring system, collect and record the quality of the medical device complaint information and medical device adverse event information, the collection of information to analyze the information collected on the possible existence of defects in the investigation and evaluation.

Medical device business enterprises, the use of units should cooperate with the medical device manufacturers to investigate the defects of medical devices, and provide relevant information.

Article 11 of the medical device manufacturers shall, in accordance with the provisions of the collection of adverse events of medical devices in a timely manner to the food and drug supervision and management departments to report, food and drug supervision and management departments can be on the adverse events of medical devices or possible defects in the analysis and investigation of medical equipment manufacturers, business enterprises, the use of units should be cooperative.

Article 12 on the existence of defective medical device products to assess the main contents include:

(a) whether the product complies with mandatory standards, registered or filed product technical requirements;

(b) in the use of medical devices in the process of whether the malfunction or injury;

(c) in the existing use of the environment whether it will cause harm. (iv) the extent of the area and characteristics of the population involved in the injury;

(v) the extent of the injury to human health;

(vi) the probability of the injury occurring;

(vii) the short- and long-term consequences of the injury occurring;

(viii ) Other factors that may cause harm to the human body.

Article 13 according to the severity of medical device defects, medical device recall is divided into:

(a) Class I recall: the use of the medical device may cause or has caused serious health hazards;

(b) Class II recall: the use of the medical device may cause or has caused a temporary or reversible health hazards;

(c) Class III recall : the use of the medical device caused by the possibility of harm is small but still need to be recalled.

Medical device manufacturers should be based on the specific circumstances to determine the level of recall and according to the recall level and the sales and use of medical devices, scientifically designed recall plan and organization and implementation.

Chapter III active recall

Article 14 of the medical device manufacturers in accordance with the requirements of Article 10, Article 12 of the investigation and assessment, to determine the existence of defects in medical device products, should immediately decide and implement the recall, and at the same time to the community to release the product recall information.

The implementation of the first level of recall, medical device recall announcement shall be published on the website of the State Food and Drug Administration and the central media; the implementation of the second and third level of recall, medical device recall announcement shall be published in the provinces, autonomous regions and municipalities directly under the Central Food and Drug Administration website, provinces, autonomous regions and municipalities directly under the Central Food and Drug Administration website shall be published with the State Food and Drug Administration website link to the recall announcement. Food and Drug Administration website link.

Article 15 of the medical device manufacturer to make a decision on the recall of medical devices, the first level of recall should be within 1 day, the second level of recall should be within 3 days, the third level of recall should be within 7 days, notified to the relevant medical device business enterprises, the use of units or inform the user.

Recall notice shall include the following:

(a) recall the name of the medical device, model specifications, batch and other basic information;

(b) the reason for the recall;

(c) recall requirements, such as the immediate suspension of the sale and use of the product, will be recalled notice forwarded to the relevant business enterprises or the use of units;

(d) the way to deal with the recall. Recall of medical devices to deal with.

Article 16 of the medical device manufacturer to make a decision on the recall of medical devices, should be immediately to the location of the province, autonomous region, municipalities directly under the Central Food and Drug Administration and approval of the product registration or for the record of the food and drug supervision and management department to submit a medical device recall event report form, and within five working days will be investigated and assessed the report and the recall plan to the location of the province, autonomous region, Municipalities directly under the Central Food and Drug Administration and approval of the registration or for the record of the food and drug supervision and management department for the record.

Medical device manufacturers in the provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration shall receive the recall incident report form within one working day to report the recall of the State Food and Drug Administration.

Article 17 of the investigation and assessment report shall include the following:

(a) the specific circumstances of the recall of medical devices, including the name, model specifications, batch and other basic information;

(b) the implementation of the reasons for the recall;

(d) the recall classification.

The recall plan should include the following:

(a) the production and sale of medical devices and the number of recalls to be made;

(b) the specific content of the recall measures, including the implementation of the organization, the scope and time frame;

(d) the expected effect of the recall;

(E) the medical device recall measures.

Article 18 of the medical device manufacturer where the provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration can produce the recall plan submitted by the manufacturer to assess that the measures taken by the manufacturer can not be effective in eliminating product defects or controlling the risk of the product, it shall be required in writing to take to increase the level of the recall, expand the scope of the recall, shorten the time of the recall, or to change the recalled product More effective measures to deal with the handling of the product. Medical device manufacturers should be in accordance with the requirements of the food and drug supervision and management department to modify the recall plan and organize the implementation.

Article 19 of the medical device manufacturers reported on the recall plan to change, should be promptly reported to the local provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration for the record.

Article 20 of the medical device manufacturers in the implementation of the recall process, should be based on the recall plan regularly to the local provinces, autonomous regions and municipalities directly under the central food and drug supervision and management department to submit a report on the implementation of the recall plan.

Article 21 of the medical device manufacturer of the recall of medical devices should have a detailed record of the treatment, and to the medical device manufacturer of the location of the provincial, autonomous regions, municipalities directly under the Central Food and Drug Administration report, the record should be kept until the expiration of the certificate of registration of the medical device for five years after the first class of medical devices recalled the processing record should be kept for five years. For the product defects can be eliminated by warning, inspection, repair, re-labeling, modification and improvement of instructions, software updates, replacement, destruction, etc., the above acts can be completed at the location of the product. Need to destroy, should be destroyed under the supervision of the Food and Drug Administration.

Article 22 of the medical device manufacturers should be recalled within 10 working days after the completion of the recall to assess the effectiveness of the recall, and to the location of the provinces, autonomous regions, municipalities directly under the central food and drug supervision and management departments to submit a summary assessment of the recall of medical devices.

Article 23 of the medical device manufacturer where the provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration shall receive a summary assessment report within 10 working days from the date of the report on the review, and the recall of the effect of the assessment; that recall has not yet been effective in eliminating defects in the product or control product risk, it shall be required in writing to the manufacturer of the re-recall. Medical device manufacturers should be in accordance with the requirements of the food and drug supervision and management department for the recall.

Chapter IV recall

Article 24 of the food and drug supervision and management department after investigation and assessment, that the medical device manufacturer should recall defective medical device products and not take the initiative to recall, shall order the medical device manufacturer to recall the medical device.

The decision to order a recall can be made by the medical device manufacturer of the province, autonomous region, municipality directly under the Central Food and Drug Administration, can also be approved by the medical device registration or for the record of the food and drug supervision and management departments. Food and drug supervision and management departments to make the decision, should be in its website to the community to order the recall of information.

Medical device manufacturers should be in accordance with the requirements of the food and drug supervision and management departments to carry out the recall, and in accordance with the provisions of the second paragraph of Article 14 of these measures to the community to publish product recall information.

If necessary, the food and drug administration can require medical device manufacturers, business enterprises and the use of units to immediately suspend the production, sale and use, and inform the user to immediately suspend the use of the defective product.

Article 25 of the food and drug supervision and management department to make the decision to order a recall, shall be ordered to recall the notice sent to the medical device manufacturer, the notice includes the following:

(a) the recall of medical devices, including the name of the specific circumstances, including the name of the model specifications, batch and other basic information;

(b) the implementation of the reasons for recall;

(c) the recall of medical devices, the recall of medical devices and the recall of medical devices, and the recall of medical devices. Investigation and evaluation results;

(d) recall requirements, including the scope and time frame.

Article 26 of the medical device manufacturer receives an order to recall the notice, shall, in accordance with the provisions of Article 15, Article 16 of these measures to notify the medical device business enterprises and the use of units or inform the user to develop, submit the recall plan, and organize the implementation.

Article 27 of the medical device manufacturer shall, in accordance with the provisions of Article 19, Article 20, Article 21, Article 22 of this approach to the food and drug supervision and management department to report the recall of medical devices, the recall of medical devices for follow-up.

Food and drug supervision and management departments shall, in accordance with the provisions of Article 23 of this approach to the medical device manufacturers to submit a summary of the medical device recall assessment report for review and evaluation of the effectiveness of the recall, and, if necessary, notify the same level of health administration. After review and evaluation, that the recall is not complete, has not been effective in eliminating product defects or controlling product risk, the food and drug administration department shall require in writing the medical device manufacturer to re-recall. Medical device manufacturers should be in accordance with the requirements of the food and drug supervision and management department for the recall.

Chapter V Legal Liability

Article 28 of the medical device manufacturers in violation of laws, rules and regulations caused by the listing of defective medical devices should be given administrative penalties in accordance with law, but the enterprise has taken recall measures to actively eliminate or mitigate the harmful consequences of food and drug supervision and management departments in accordance with the "People's Republic of China *** and the State Law on Administrative Penalties," the provisions of the given Light or reduced penalties; violations of minor and timely correction, did not cause harmful consequences, not punishable.

Medical device manufacturers to recall medical devices, not exempt from other legal responsibility.

Article 29 of the medical device manufacturers in violation of the provisions of Article 24, refused to recall medical devices, according to the "supervision and management of medical devices regulations" Article 66 of the provisions of the treatment.

Article 30 of the medical device manufacturer of one of the following circumstances, shall be warned, ordered to make corrections within a specified period of time, and impose a fine of 30,000 yuan:

(a) violation of the provisions of Article 14 of these Measures, did not in accordance with the requirements of the timely release of the product recall information to the community;

(b) violation of the provisions of Article 15 of these Measures, did not in the prescribed time to the recall of medical devices. Decision to notify the medical device business enterprises, the use of units or inform the user;

(C) violation of the provisions of Article 18, Article 23, Article 27, paragraph 2, not in accordance with the requirements of the food and drug supervision and management departments to take corrective measures or re-recall of medical devices;

(D) violation of the provisions of Article 21 of the recall of medical devices, or the recall of medical devices Handling of detailed records or not reported to the food and drug supervision and management department.

Article 31 of the medical device manufacturer of one of the following circumstances, shall be warned and ordered to make corrections within a specified period of time; overdue correction, a fine of 30,000 yuan:

(a) not in accordance with the provisions of this approach to establish a medical device recall management system;

(b) refused to cooperate with the food and drug supervision and management departments to carry out investigations;

(d) not in accordance with the provisions of this approach to submit the recall of medical devices. In accordance with the provisions of this approach to submit a medical device recall incident report form, investigation and assessment report and recall plan, medical device recall plan implementation and summary assessment report;

(d) change the recall plan, did not report to the food and drug supervision and management department for the record.

Article 32 of the medical device business enterprises, the use of units in violation of the provisions of Article 7, paragraph 1 of these measures, shall order to stop the sale and use of defective medical devices, and impose a fine of 5,000 yuan more than 30,000 yuan; resulting in serious consequences, by the original issuance of the department revoke the "medical device license".

Article 33 of the medical device business enterprises, the use of units refused to cooperate with the investigation of defective medical devices, refused to assist the medical device manufacturer to recall the medical device, shall be warned and ordered to make corrections within a period of time; overdue refusal to make corrections, a fine of 30,000 yuan.

Article 34 of the food and drug supervision and management departments and their staff do not perform the supervision and management of medical devices or abuse of power, dereliction of duty, one of the following circumstances, by the supervisory organ or appointment and removal of the organ in accordance with the circumstances of the seriousness of the case, the directly responsible for the supervisor and other personnel directly responsible for the criticism and education, or according to the law to give a warning, a demerit or demerit points of the sanctions; resulting in Serious consequences, given the punishment of demotion, dismissal or expulsion:

(a) not in accordance with the provisions of the recall information released to the community;

(b) not in accordance with the provisions of the recall information to the relevant departments to report or notify;

(d) violation of Article 23 and the second paragraph of Article 27 of the present Measures, failed to take measures of recall;

(d) violation of this Measures, and the second paragraph of the provisions of Article 27, the failure of the recall measures. The second paragraph of Article 27, failed to urge medical device manufacturers to effectively implement the recall.

Chapter VI By-laws

Article 35 of the recall of medical devices have been implanted in the human body, medical device manufacturers should be with the medical institutions and patients **** with the consultation, according to the different reasons for the recall of the patient's treatment and should be taken in advance measures.

Article 36 of the recall of medical devices to the patient caused damage, the patient can ask for compensation to the medical device manufacturer, but also to the medical device business enterprises, the use of units to claim compensation. Patients to the medical device business enterprises, the use of units for compensation, medical device business enterprises, the use of units for compensation, the right to the responsible medical device manufacturer to recover.

Article 37 of the Measures shall come into force on May 1, 2017, July 1, 2011, the "Medical Device Recall Management Measures (Trial)" (People's Republic of China *** and the State Ministry of Health Decree No. 82) shall be repealed simultaneously.

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