Medical Device Recall Management Procedures (Trial Implementation)

Original Language Title: 医疗器械召回管理办法(试行)

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Read the untranslated law here: http://www.chinalaw.gov.cn/article/fgkd/xfg/gwybmgz/201109/20110900349574.shtml

Medical device recall management procedures (trial implementation)

    (Released May 20, 2011, the Ministry of health, the 82nd come into force July 1, 2011) Chapter I General provisions

    First to strengthen the supervision and administration of medical devices, protection of human health and safety, under the supervision and administration of medical devices regulations, the State Council on strengthening food and other product safety supervision and management of special provisions, these measures are formulated.

    Article in the People's Republic of China recalls of medical devices sold in supervision and management, application of this approach.

    Third recalls of medical devices in these measures refers to medical device manufacturers in accordance with the procedure provided for its flawed marketed a type, model or batch of products, take warning, check, repair, return labels, modify and improve manuals, software upgrades, replacement, recovery, destruction or any other means to eliminate defects.

    The fourth flaw in these measures refers to medical device under normal use conditions exist that might threaten human health and safety of unreasonable risk.

    Article fifth medical device manufacturing enterprises are subject to control and eliminate product defects shall be responsible for the security of their products.

Sixth production enterprises shall, in accordance with the medical devices regulations establishing and perfecting medical device recall system, collect information on medical device safety, there may be a defect investigation, assessment of the medical device, recall of defective medical devices in a timely manner.

    Medical device distributing enterprise, and use should assist medical device manufacturing enterprises to fulfill their recall obligations, in accordance with the recall program requires timely communication, feedback of medical device recall information, control and recovery of defective medical devices.

Seventh article medical devices business enterprise, and using units found its business, and using of medical devices exists defects of, should immediately suspended sales or using the medical devices, timely notification medical devices production enterprise or dealer, and to location province, and autonomous regions, and municipalities drug supervision management sector report; using units for medical institutions of, also should while to location province, and autonomous regions, and municipalities health administrative sector report.

    Medical device distributing enterprise, and use the location of provinces, autonomous regions and municipalities directly under the drug regulatory department upon receipt of the report, shall promptly inform the medical device manufacturing enterprises are located province, autonomous region, or municipality directly under the supervision and regulation Department.

Article eighth recall of medical devices manufacturers, imports of medical devices outside the manufacturer's authorized agent location in China provinces, autonomous regions and municipalities directly under the pharmaceutical supervisory and Administrative Department is responsible for the supervision and administration of medical device recalls and other drug regulatory agency of provinces, autonomous regions and municipalities should cooperate with, and assist in the area of medical device recall-related work.

    State food and drug administration, national management of medical device recalls.

    The Nineth and the State food and drug administration of provinces, autonomous regions and municipalities directly under the pharmaceutical supervisory and administrative departments shall establish a medical device recall communications and open system to inform the public health administrative departments at the relevant information in a timely manner, adopt effective ways to publicize defective medical device information and medical device recalls.

    Chapter II medical device defect investigation and assessment

The tenth medical device manufacturer shall establish a sound quality management systems and medical device adverse event monitoring system, collect and record quality of medical devices and medical device adverse event information, to analyze the information gathered, to investigate possible defects medical equipment and evaluation.

    Medical device distributing enterprise, shall cooperate with the medical device manufacturing enterprises to carry out surveys on medical device defects, and provide relevant information.

    11th medical device manufacturers should be in accordance with the provisions of article will be collected in a timely manner information on medical device adverse event reports to the pharmaceutical supervisory and administrative departments, pharmaceutical supervision and management departments of medical device adverse event information or there may be a defect analysis and investigation, medical device manufacturers, drug distributors, and use shall provide assistance.

12th medical device defect evaluation of main contents include:

(A) in the course of using medical devices if faults or damage has occurred;

(B) in the existing environment will cause harm, whether related to scientific literature, research, testing or verification can explain the cause of injuries;

(C) damage the scope area and population characteristics;

(D) the extent of harm to human health;

(E) the probability of injury;

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

    (VII) other factors that may cause harm to the human body.

13th according to the severity of medical device defects and recalls of medical devices are divided into:

(A) level of recall: use this medical device or cause serious health hazards;

(B) secondary recall: use the medical devices may or may have caused a temporary or reversible health effects;

(C) three levels of recall: use this medical device to cause harm is less likely but still need to be recalled.

    Medical device manufacturing enterprise based on recall should be graded with the sale and use of medical devices, science designed to recall and organize the implementation of the plan.

    Chapter III voluntary recall

14th medical device manufacturing enterprises in accordance with the present article tenth, 12th, requesting an investigation of assessment, identified a defect in medical devices, should be immediately recalled.

    Foreign manufacturers of imported medical devices outside of medical device recalls, it shall notify the authorized agent in China by its timely report to the State food and Drug Administration; recalled in the territory, by its authorized agent within Chinese territory in accordance with the provisions for implementation of the measures.

15th medical device manufacturers make recall decisions, recalled 1st level secondary recall within the 3rd, three levels of recall in the 7th, notified to the medical device distributing enterprise, and use or to inform users.

Recall notice should include at least the following:

(A) recall basic information such as name, batch of medical devices;

(B) the reasons for recall;

(C) recall requires: if they immediately suspended the sale and use of the product, the recall notice is forwarded to the relevant enterprises or units;

    (D) handling of recalled medical devices.

Article 16th medical device manufacturers make recall decisions, shall immediately notify the drug regulatory agency of provinces, autonomous regions and municipalities directly under the seat, and fill in the 5th of the medical device recall reporting form (see attachment 1), and to submit the investigation report and recall program as well as to location of provinces, autonomous regions and municipalities directly under the pharmaceutical supervisory and administrative departments.

    The provinces, autonomous regions and municipalities directly under the level of the pharmaceutical supervisory and administrative departments shall recall the situation promptly report to the State food and drug administration.

17th assessment report should include the following:

(A) the case of recalled medical devices, including basic information such as name, batch;

(B) the reasons for recall;

(C) the survey results;

(D) recalls graded.

Recall program should include the following:

(A) the production and sales of medical devices and intended to recall the number of

(B) recalls the specific contents, including the Organization, scope and duration of;

(C) published approach and scope of the recall information;

(D) recalls the expected results;

    (E) medical device recall after treatment.

    18th pharmaceutical supervisory and administrative department according to organize experts to assess medical device manufacturers to submit recall plans, medical device manufacturing enterprise of the measures taken is not effective in eliminating defects, medical device manufacturers should be required to take action to improve recall levels, expanded recall range, shortening the recall time or change handling of the recalled product, such as more effective measures.

    19th recall program for medical device manufacturers to report changes, shall report the pharmaceutical supervisory and administrative department.

    20th medical device manufacturing enterprises in the process of recall should be submitted regularly to the drug regulatory Department under the recall plan the recall program implementation report (see table 2), recall program implementation. 21st medical device manufacturers on recalls of medical devices should have detailed records, and medical device manufacturing enterprises are located province, autonomous region, or municipality directly under the supervision and Management Department reports. Through alerts, check, repair, return labels, modify and improve manuals, software upgrades, replacement, destruction or any other means to eliminate product defects can be located above.

    To be destroyed, to pharmaceutical supervisory and administrative departments shall be destroyed under the supervision of the destruction.

    22nd medical device manufacturers in recall is completed, should evaluate the effect on the recall, recall and finished 10th to the pharmaceutical supervisory and administrative departments within medical device recall summary reports. 23rd the pharmaceutical supervisory and administrative departments shall, from the date of receipt of the summary report to review the report in the 10th, and to evaluate the effect on the recall.

Review and evaluation findings shall be notified in writing to medical device manufacturers with a copy to health administration departments at the same level.

    After review and assessment, think a recall is not complete, yet effective elimination of defects, pharmaceutical supervisory and administrative departments shall require medical device manufacturers to bring back.

    Fourth chapter shall be ordered to recall

24th after an investigation to assess the drug regulatory agency, referred to in this article fourth flaw considered, medical device manufacturers should recall without a voluntary recall of medical devices, shall order the manufacturer recalls of medical devices medical devices.

    If necessary, the pharmaceutical supervisory and administrative departments shall require medical device manufacturing enterprises, trading enterprises and units to immediately suspend sales or use, inform users to immediately suspend use of the medical device.

25th pharmaceutical supervisory and administrative departments shall be ordered to recall decision, ordered a recall notice should be served on medical device manufacturers or import medical device manufacturers of domestic agents, includes the following:

(A) the case of recalled medical devices, including basic information such as name, batch;

(B) the reasons for recall;

(C) the survey results;

    (D) the recall requirements, including scope and duration, and so on.

    26th medical device manufacturers receive ordered a recall notice, shall, in accordance with article 15th, 16th section informed the medical device business enterprises and units or inform users, develop, submit recall plans, and their implementation.

27th medical device manufacturing enterprises shall be in accordance with the way the 19th, 20th, 21st, 22nd section reporting to the pharmaceutical supervisory and administrative departments of medical device recalls, recalled the subsequent processing of medical devices. Pharmaceutical supervisory and administrative departments shall, in accordance with the provisions of the present article 23rd submitted by the medical device manufacturer medical device recalls summary report review and recall effect evaluation to inform the health Administrative Department at the same level.

    After review and assessment, think a recall is not complete, yet effective elimination of defects, pharmaceutical supervisory and administrative departments shall require medical device manufacturers to bring back.

    The fifth chapter legal liability

The 28th pharmaceutical supervisory and Administrative Department of medical device manufacturing companies for violating laws, regulations, rules and regulations listed medical device defects, should be given administrative punishments according to law, but recalls the enterprise has taken the initiative to eliminate or mitigate harmful consequences, in accordance with the provisions of the law on administrative punishment lighter or mitigated punishment offence minor and corrected without causing harm, not to punish.

    Medical device manufacturer recalls of medical devices, is not exempt shall bear the legal responsibility.

    29th medical device manufacturing enterprises in violation of the rules, found no active medical device defects and recalls of medical devices, to order the recall of medical devices, and a value of recalled medical devices should be 3 times the amount of the fine, causing serious consequences, the original issuing authorities shall revoke product registration certificate of medical devices until the revocation of the medical device manufacturing enterprise license.

    30th medical apparatus production enterprise violates the provisions article 24th of this approach, refused to recall of medical devices, values of recalled medical devices should be 3 times the amount of the fine, causing serious consequences, the original issuing authorities shall revoke product registration certificate of medical devices until the revocation of the medical device manufacturing enterprise license.

31st medical apparatus production enterprise, one of the following circumstances, with a warning, rectification, and fines of between 30,000 Yuan:

(A) disobey the 15th article is not within the specified time of recalled medical device decision shall be communicated to the medical device business, unit or inform users;

(B) disobey the 18th, 23rd article, 27th, second paragraph, is not in accordance with the pharmaceutical supervisory and administrative departments to take corrective measures or recalled medical devices;

    (C) in violation of this article approaches the 21st, recalls of medical devices is not detailed records or failing to report to the pharmaceutical supervisory and administrative departments.

32nd medical apparatus production enterprise, one of the following circumstances, be warned that a rectification; fails to mend, and fines of between 30,000 Yuan:

(A) medical device recall system established in accordance with this approach;

(B) refuses to assist pharmaceutical supervisory and administrative department to carry out investigations;

(C) it is not submitted in accordance with the rules of the medical device recall reporting form, investigation reports and recall plans, medical device recalls and summary report on the implementation of the plan;

    (D) change the recall program, not reported pharmaceutical supervisory and administrative departments for the record.

    Article 33rd medical device distributing enterprise, and use in violation of these regulations of the seventh article, shall be ordered to stop sale, use of defective medical devices, and a 1000 Yuan and 30,000 yuan fines; causing serious consequences, the original issuing authorities shall revoke the medical device distributing Enterprise license.

    Article 34th medical device distributing enterprise, users refused to cooperate with the relevant medical device defect investigations, refused to help medical device manufacturers of recalled medical devices, with a warning and order them to correct; it refuses, and fines of between 30,000 yuan.

    35th pharmaceutical supervisory and administrative departments and their staff failed to perform their duties or abuse, be dealt with in accordance with the provisions of relevant laws and regulations.

    The sixth chapter supplementary articles

    36th recalled medical devices already implanted medical device manufacturing enterprises shall consult with the medical institutions and patients together, depending on the recall reasons put forward views on the treatment of patients and plan measures to be taken. 37th recalled medical devices pose risk to patients, patients can request compensation from the manufacturer, or you can request compensation from the medical device business, and use of.

    Patients to the medical device business, and use the request for compensation, medical devices business, and use of compensation, the right to recourse against the responsible manufacturer.

    38th article of the rules take effect on July 1, 2011.

          Schedule: 1. medical device recall reporting form 2. recall programme implementation reports
    Appendix 1: medical device recall reporting form
┌─────────────┬─────┬──────────┬─────┐
│         产品名称         │          │     注册证号码     │          │
├─────────────┼─────┴──────────┴─────┤
│         生产企业         │                                            │
├─────────────┼──────────────────────┤
│中国境内负责单位、负责人及│                                            │
│         联系方式         │                                            │
├─────────────┼──────────────────────┤
│ 召回工作联系人和联系方式 │                                            │
├─────────────┼──────────────────────┤
│      产品的适用范围      │                                            │
├─────────────┼─────┬──────────┬─────┤
│      涉及地区和国家      │          │      涉及产品      │          │
│                          │          │     型号、规格     │          │
├─────────────┼─────┼──────────┼─────┤
│ About us │ products │ products production in China of sale │ │
│    (或进口中国)数量    │          │        数量        │          │
├─────────────┼─────┴──────────┴─────┤
│         识别信息         │                                            │
│        (如批号)        │                                            │
├─────────────┼──────────────────────┤
│       召回原因简述       │                                            │
│                          │                                            │
├─────────────┼──────────────────────┤
│       纠正行动简述       │                                            │
  └─────────────┴──────────────────────┘

Reporting unit: (seal) Director: (signature)

Speaker: (signature) date of report:

Table 2: the recall program implementation reports
┌─────────────┬───────┬─────┬────────┐
│         产品名称         │              │注册证号码│                │
├─────────────┼───────┴─────┴────────┤
│         生产企业         │                                            │
├─────────────┼──────────────────────┤
│中国境内负责单位、负责人及│                                            │
│         联系方式         │                                            │
├─────────────┼──────────────────────┤
│     召回工作联系人和     │                                            │
│         联系方式         │                                            │
├─────────┬───┴───┬───────┬──────────┤
│                  │              │ 应当通知人数 │                    │
│                  │              ├───────┼──────────┤
│                  │ 承担召回联系 │  已通知人数  │                    │
│        通        │ 责任的收货人 ├───────┼──────────┤
│                  │              │   通知时间   │                    │
│        知        │              ├───────┼──────────┤
│                  │              │   通知方式   │                    │
│        情        ├───────┼───────┼──────────┤
│                  │              │ 应当通知人数 │                    │
│        况        │              ├───────┼──────────┤
│                  │              │  已通知人数  │                    │
│                  │  其他收货人  ├───────┼──────────┤
│                  │              │   通知时间   │                    │
│                  │              ├───────┼──────────┤
│                  │              │   通知方式   │                    │
├─────────┼───────┼───────┴──────────┤
│        完        │ 应当召回数量 │                                    │
│                  │              │                                    │
│        成        ├───────┼──────────────────┤
│                  │  已完成数量  │                                    │
│        情        │              │                                    │
│                  ├───────┼──────────────────┤
│        况        │有效性检查情况│                                    │
│                  │              │                                    │
├─────────┴───────┼──────────────────┤
│        召回产品的处理措施        │                                    │
├─────────────────┼──────────────────┤
│       完成召回需要时间估计       │                                    │
├─────────┬───────┴──────────────────┤
│                  │                                                    │
│                  │                                                    │
│                  │                                                    │
│                  │                                                    │
│                  │                                                    │
│                  │                                                    │
│        其        │                                                    │
│                  │                                                    │
│        他        │                                                    │
│                  │                                                    │
│        情        │                                                    │
│                  │                                                    │
│        况        │                                                    │
│                  │                                                    │
│                  │                                                    │
│                  │                                                    │
│                  │                                                    │
│                  │                                                    │
│                  │                                                    │
  └─────────┴──────────────────────────┘

Reporting unit: (seal) Director: (signature) Speaker: (signature) date of report: