Chapter I General Provisions
Article 1 In order to strengthen the supervision and management of medical devices, to protect human health and life safety, according to the "supervision and management of medical devices regulations", "the State Council on strengthening the supervision and management of food and other product safety special provisions", the development of these measures.
Second, the recall of medical devices sold in the territory of the Chinese people*** and its supervision and management, shall apply to these measures.
Article 3 The recall of medical devices referred to in these Measures refers to the recall of medical devices manufacturers in accordance with the prescribed procedures for the products of a certain category, model or batch which have been listed for sale with defects, to take warning, inspection, repair, re-labeling, modification and improvement of the manuals, software upgrades, replacements, retrieval, and destruction of products to eliminate the defects of the behavior.
Article 4 The defects referred to in these measures, refers to medical devices in normal use there may be an unreasonable risk of endangering human health and life safety.
Article V The medical device manufacturer is the main body to control and eliminate product defects, should be responsible for the safety of the products it produces.
Article VI medical device manufacturers shall establish and improve the medical device recall system in accordance with the provisions of these measures, collect relevant information on the safety of medical devices, investigate and evaluate the possible defects of medical devices, and recall defective medical devices in a timely manner.
Medical device business enterprises, the use of units should assist the medical device manufacturer to fulfill the recall obligations, in accordance with the requirements of the recall plan in a timely manner to convey, feedback medical device recall information, control and recovery of defective medical devices.
Article VII of the medical device business enterprises, the use of medical devices found to be operating, the use of medical devices are defective, shall immediately suspend the sale or use of the medical device, and promptly notify the medical device manufacturer or supplier, and to the location of the province, autonomous region, municipality directly under the central drug supervision and management department; use of the unit of the medical institutions, but also shall also be the same time to the location of the province, autonomous region, Municipalities directly under the Central Health Administration report.
Medical device business enterprises, the use of the local province, autonomous region, municipality directly under the central drug supervision and management department shall promptly notify the medical device manufacturer of the local province, autonomous region, municipality directly under the central drug supervision and management department.
Article VIII of the recall of medical devices manufacturers, imported medical devices, foreign manufacturers in China designated by the agent of the provincial, autonomous regions, municipalities directly under the Central Drug Administration is responsible for the supervision and management of the recall of medical devices, other provinces, autonomous regions, municipalities directly under the Central Drug Administration shall cooperate with, and assist in doing the work of the recall of medical devices within the jurisdiction of the relevant 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 Drug Administration shall establish a medical device recall information notification and disclosure system, timely notification of relevant information to the health administrative departments at the same level, and to take effective means to the community to publish information on the existence of defective medical devices and the recall of medical devices.
Chapter II: Investigation and Evaluation of Medical Device Defects
Article 10 The medical device manufacturer shall establish and improve the quality management system of medical devices and medical device adverse event monitoring system, collect and record the quality of medical devices and medical device adverse event information, analyze the collected information, investigate and evaluate the possible defects of medical devices.
Medical device business enterprises, the use of units should cooperate with medical device manufacturers to carry out investigations on medical device defects, and provide relevant information.
Article XI of the medical device manufacturer shall in accordance with the provisions of the collected medical device adverse event information to the drug supervision and management department report in a timely manner, the drug supervision and management department can be on the medical device adverse event information or possible defects in the analysis and investigation of medical devices, medical device manufacturers, business enterprises, the use of units should be assisted.
Article 12 The main contents of the assessment of defects of medical devices include:
(1) Whether failure or injury has occurred during the use of medical devices;
(2) Whether the injury will be caused under the existing use environment, and whether there is any scientific literature, research, relevant experiments or validation that can explain the reason for the occurrence of the injury;
(3) The extent of the area and characteristics of the population involved in the injury;
(iv) The degree of harm caused to human health;
(v) The probability of the injury occurring;
(vi) The short- and long-term consequences of the occurrence of the injury;
(vii) Other factors that may cause harm to the human body.
Article XIII According to the severity of the medical device defects, medical device recall is divided into:
(1) Class I Recall: the use of the medical device may cause or has caused serious health hazards;
(2) Class II Recall: the use of the medical device may cause or has caused temporary or reversible health hazards;
(3) Class III Recall (C) Class III Recall: the use of the medical device is less likely to cause harm, but still need to be recalled.
Medical device manufacturers should be based on the recall classification and sales and use of medical devices, scientifically designed recall plan and organization and implementation.
Chapter III Active Recall
Article XIV of the medical device manufacturers in accordance with the requirements of Article 10, Article 12 of the investigation and assessment, found that there are defects in medical devices, shall immediately decide to recall.
Imported medical devices of foreign manufacturers outside the implementation of medical device recall, shall notify its designated agent in China to report to the State Food and Drug Administration in a timely manner; in the territory of the recall, by its designated agent in China is responsible for the specific implementation in accordance with the provisions of these Measures.
Article XV of the medical device manufacturer to make a decision on the recall of medical devices, the first level of recall within 1 day, the second level of recall within 3 days, the third level of recall within 7 days, notified to the relevant medical device business enterprises, the use of units or inform the user.
Recall notification should include at least the following content:
(a) recall of medical devices, such as the name of the batch of 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 forwarded to the relevant business enterprises or use of the notice of the recall;
(d) the recall of the The treatment of medical devices.
Article XVI of the medical device manufacturer to make a decision on the recall of medical devices, should be immediately informed in writing to the location of the province, autonomous region, municipality directly under the central drug supervision and management department, and within five days to fill out the "Medical Device Recall Incident Reporting Form" (see Exhibit 1), will be investigated and assessed the report and the recall plan submitted to the location of the province, autonomous region, municipality directly under the central drug supervision and management department for the record.
Provinces, autonomous regions, municipalities directly under the Central Drug Administration shall promptly report to the State Food and Drug Administration of the first level of recall of the relevant situation.
Article XVII of the investigation and assessment report shall include the following:
(a) the recall of medical devices, including the name, batch and other basic information;
(b) the implementation of the reasons for the recall;
(c) the results of the investigation and assessment;
(d) the recall of graded.
The recall plan should include the following:
(I) the production and sale of medical devices and the number of proposed recall;
(II) the specific content of the recall measures, including the implementation of the organization, scope and time frame;
(III) the recall information published way and scope;
(IV) the expected effect of the recall;
(E) the medical device recall measures.
Article 18 The drug supervision and management department may, according to the actual situation, organize experts to assess the recall plan submitted by the medical device manufacturer, and if it is believed that the measures taken by the medical device manufacturer can not effectively eliminate the defects, the medical device manufacturer shall be required to take measures to increase the level of the recall, expand the scope of the recall, shorten the time of the recall, or change the handling of the recalled products and other more effective measures. The measures.
Article 19 of the medical device manufacturers to report changes in the recall program, shall promptly report to the drug supervision and management department for the record.
Article 20 The medical device manufacturer in the implementation of the recall process, should be based on the recall plan regularly to the drug supervision and management department to submit a "recall plan implementation report" (see Annex 2), report on the implementation of the recall plan.
Article 21 The medical device manufacturer shall have a detailed record of the treatment of recalled medical devices, and report to the drug supervision and management department of the province, autonomous region and municipality directly under the central government where the medical device manufacturer is located. For through the warning, inspection, repair, re-labeling, modify and improve the instructions, software upgrades, replacement, destruction and other ways to eliminate product defects can be completed in the product location of the above acts. Need to destroy, should be destroyed under the supervision of the destruction of drug supervision and management departments.
Article 22 of the medical device manufacturers in the recall is completed, the recall shall evaluate the effect, and in the recall is completed within 10 days after the completion of the drug supervision and management department to submit a summary report on the recall of medical devices.
Article 23 The drug supervision and management department shall, within 10 days from the date of receipt of the summary report, review the report and evaluate the recall effect. Review and evaluation of the conclusions shall be notified in writing to the medical device manufacturer and copied to the same level of health administration.
After the review and evaluation, that the recall is not complete, has not been effective in eliminating defects, the drug supervision and management department shall require medical device manufacturers to re-recall.
Chapter IV Ordered Recall
Article 24 The drug supervision and management department, after investigation and evaluation, that there are defects referred to in Article 4 of these Measures, the medical device manufacturer should recall the medical device without the initiative to recall, shall order the medical device manufacturer to recall the medical device.
When necessary, the drug administration department shall require medical device manufacturers, operators and users to immediately suspend the sale or use, inform the user to immediately suspend the use of the medical device.
Article 25 The drug supervision and management department to make the decision to order a recall, shall order a recall notice to be sent to the medical device manufacturer or imported medical device manufacturer's domestic agent, the notice includes the following content:
(a) the recall of medical devices, including the name of the recall of the specifics of medical devices, including the name of the batch and other basic information;
(b) the reasons for the implementation of the recall
(iii) the results of the investigation and assessment;
(iv) recall requirements, including the scope and time limit.
Article 26 The medical device manufacturer receives the 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 The medical device manufacturer shall report to the drug supervision and management department in accordance with the provisions of Article 19, Article 20, Article 21, Article 22 of these measures to report the recall of medical devices, the follow-up processing of recalled medical devices.
Drug supervision and management department shall, in accordance with the provisions of Article 23 of these measures, medical device manufacturers to submit a summary report on the recall of medical devices for review, and evaluation of the recall effect, and timely notification of the same level of health administration. After review and evaluation, that the recall is not complete, has not been effective in eliminating defects, the drug supervision and management department shall require the medical device manufacturer to re-recall.
Chapter V Legal Liability
Article 28 The drug supervision and management department confirms that the medical device manufacturer in violation of laws, rules and regulations caused by the listed medical device defects, according to law shall be given administrative punishment, but the enterprise has taken recall measures to take the initiative to eliminate or mitigate the harmful consequences of the provisions in accordance with the "Administrative Punishments Act" shall be mitigated or reduced penalties; Violations of the law is minor and timely correction, did not cause harmful consequences, shall not be punished.
Medical device manufacturers to recall medical devices, not exempt from other legal responsibility it should bear.
Article 29 of the medical device manufacturers in violation of the provisions of these measures, found that the medical device is defective and did not take the initiative to recall the medical device, shall order the recall of medical devices, and shall be subject to a recall of the medical device value of the amount of three times the fine; cause serious consequences, by the original issuance of the department of the revocation of the certificate of registration of medical device products, until the revocation of the "medical device manufacturer's license".
Article 30 of the medical device manufacturers in violation of the provisions of Article 24, refused to recall the medical device, the value of the medical device should be recalled three times the amount of the fine; cause serious consequences, by the original licensing department to revoke the certificate of registration of medical device products until the revocation of the "medical device manufacturer's license".
Article 31 The medical device manufacturer of one of the following circumstances, shall be warned and ordered to make corrections within a period of time, and impose a fine of up to 30,000 yuan:
(a) violation of the provisions of Article 15 of these Measures, failure to notify within the specified time to the decision to recall medical devices to the medical device business enterprises, the use of the unit or to inform the user;
(b) violation of the provisions of Article 18, Article 23, paragraph 2, of these Measures. Article 18, Article 23, paragraph 2, Article 27, paragraph 2, not in accordance with the requirements of the drug supervision and management department to take corrective measures or re-recall medical devices;
(3) violation of the provisions of Article 21 of these Measures, did not make a detailed record of the handling of the recalled medical devices or failed to report to the drug supervision and management department.
Article 32 The medical device manufacturer of one of the following circumstances, shall be warned and ordered to make corrections within a certain period of time; if no corrections are made after the expiration of the period of time, shall be imposed a fine of not more than 30,000 yuan:
(1) Failure to establish the recall system of medical devices according to the provisions of these Measures;
(2) Refusal to assist the drug supervision and management department to carry out investigations;
(3) Failure to submit the "Medical Device Recall Incident" as stipulated by the Measures. Provides for the submission of "Medical Device Recall Incident Report Form", investigation and assessment report and recall plan, the implementation of the medical device recall plan and summary report;
(D) change the recall plan, not reported to the drug regulatory authorities for the record.
Article 33 of the medical device business enterprises, the use of units in violation of the provisions of Article 7, paragraph 1 of these measures, shall be ordered to stop the sale and use of defective medical devices, and impose a fine of more than 1,000 yuan of 30,000 yuan or less; causing serious consequences, by the original issuance of the license department shall revoke the "Medical Device Business License".
Article 34 of the medical device business enterprises, the use of units refused to cooperate with the medical device defects investigation, refused to assist the medical device manufacturer to recall the medical device, shall be warned and ordered to correct; refused to make corrections, shall be fined not more than 30,000 yuan.
Article 35 The drug supervision and management departments and their staff do not fulfill their duties or abuse of power shall be dealt with in accordance with relevant laws and regulations.
Chapter VI Supplementary Provisions
Article 36 If the recalled medical device has been implanted into the human body, the medical device manufacturer shall consult with the medical institution and the patient *** with the patient, according to the different reasons for the recall, and put forward the opinion on the treatment of the patient and the measures that should be taken to prepare for the recall.
Article 37 of the recall of medical devices to the patient caused damage, the patient can request compensation to the manufacturer, but also to the medical device business enterprises, the use of units to request compensation. The patient to the medical device business enterprises, the use of units to request compensation, medical device business enterprises, the use of units after compensation, the right to recover from the responsible production enterprises.
Article 38 These Measures shall come into force on July 1, 2011 .
Schedule
1. Medical Device Recall Incident Report Form
2. Report on the Implementation of the Recall Program