Promulgated by: China Food and Drug Administration (CFDA). Order No. 29 of the China Food and Drug Administration. The Measures for the Administration of Medical Device Recall, having been deliberated and adopted at the executive meeting of the China Food and Drug Administration on January 5, 2017, are hereby promulgated and shall come into force on May 1, 2017.
Commissioner: Bi Jingquan January 25, 2017
Chapter 1 General Provisions
Article 1. These Measures are formulated in accordance with the Regulation on the Supervision and Administration of Medical Devices in order to strengthen the supervision and administration of medical devices, control defective medical device products, eliminate medical device safety hazards, ensure the safety and effectiveness of medical devices, and safeguard human health and life safety.
Article 2. The recall of marketed medical devices within the territory of the People’s Republic of China and the supervision and administration thereof shall be governed by these Measures.
Article 3. For the purposes of these Measures, medical device recall refers to the act whereby a medical device manufacturing enterprise, in accordance with prescribed procedures, handles a defective medical device product of a certain category, model or batch that it has marketed and sold, by means of warning, inspection, repair, relabeling, modifying and improving the instructions, software updating, replacement, retrieval, destruction or other methods.
The medical device manufacturing enterprise referred to in the preceding paragraph means a domestic medical device product registrant or filer, or the agent designated within the territory of China by the overseas manufacturer of an imported medical device.
Article 4. For the purposes of these Measures, defective medical device products include:
(I) products that, under normal use, pose unreasonable risks that may endanger human health and life safety;
(II) products that do not conform to the mandatory standards or the registered or filed product technical requirements;
(III) products that do not conform to the relevant provisions on quality management of medical device manufacturing and distribution, thereby possibly posing unreasonable risks;
(IV) other products that need to be recalled.
Article 5. The medical device manufacturing enterprise is the entity responsible for controlling and eliminating product defects, and shall take the initiative to implement the recall of defective products.
Article 6. Medical device manufacturing enterprises shall, in accordance with the provisions of these Measures, establish and improve a medical device recall management system, collect information relating to medical device safety, investigate and assess potential defective products, and promptly recall defective products.
The agent designated within the territory of China by the overseas manufacturer of an imported medical device shall promptly report to the China Food and Drug Administration the relevant information on medical device recalls implemented only outside the territory; where a recall is to be implemented within the territory, the agent designated within the territory of China shall organize the implementation in accordance with the provisions of these Measures.
Medical device distribution enterprises and using entities shall actively assist medical device manufacturing enterprises in investigating and assessing defective products, take the initiative to cooperate with manufacturing enterprises in performing recall obligations, and, in accordance with the recall plan, promptly convey and feed back medical device recall information and control and retrieve defective products.
Article 7. Where a medical device distribution enterprise or using entity discovers that a medical device it distributes or uses may be a defective product, it shall immediately suspend the sale or use of the medical device, promptly notify the medical device manufacturing enterprise or supplier, and report to the food and drug administration department of the province, autonomous region or municipality directly under the Central Government where it is located; where the using entity is a medical institution, it shall also simultaneously report to the health administration department of the province, autonomous region or municipality directly under the Central Government where it is located.
After receiving the report, the food and drug administration department of the province, autonomous region or municipality directly under the Central Government where the medical device distribution enterprise or using entity is located shall promptly notify the food and drug administration department of the province, autonomous region or municipality directly under the Central Government where the medical device manufacturing enterprise is located.
Article 8. The food and drug administration department of the province, autonomous region or municipality directly under the Central Government where the manufacturing enterprise of the recalled medical device is located shall be responsible for the supervision and administration of the medical device recall, and the food and drug administration departments of other provinces, autonomous regions and municipalities directly under the Central Government shall cooperate in carrying out the relevant work of the medical device recall within their respective administrative regions.
The China Food and Drug Administration shall supervise the administration of medical device recalls throughout the country.
Article 9. The China Food and Drug Administration and the food and drug administration departments of the provinces, autonomous regions and municipalities directly under the Central Government shall, in accordance with the relevant systems for the notification and disclosure of medical device recall information, adopt effective channels to disclose to the public the defective product information and recall information, and shall, where necessary, notify the relevant information to the health administration department at the same level.
Chapter 2 Investigation and Assessment of Medical Device Defects
Article 10. Medical device manufacturing enterprises shall, in accordance with the provisions, establish and improve a medical device quality management system and a medical device adverse event monitoring system, collect and record medical device quality complaint information and medical device adverse event information, analyze the collected information, and investigate and assess potential defects.
Medical device distribution enterprises and using entities shall cooperate with medical device manufacturing enterprises in investigating the relevant medical device defects and provide the relevant materials.
Article 11. Medical device manufacturing enterprises shall, in accordance with the provisions, promptly report the collected medical device adverse event information to the food and drug administration departments. The food and drug administration departments may analyze and investigate medical device adverse events or potential defects, and medical device manufacturing enterprises, distribution enterprises and using entities shall cooperate.
Article 12. The main contents of the assessment of defective medical device products include:
(I) whether the product conforms to the mandatory standards and the registered or filed product technical requirements;
(II) whether any malfunction or injury has occurred in the course of using the medical device;
(III) whether injury would be caused in the existing use environment, and whether there is scientific literature, research, relevant tests or verification that can explain the cause of the injury;
(IV) the geographical scope involved in the injury and the characteristics of the affected population;
(V) the degree of injury caused to human health;
(VI) the probability of the injury occurring;
(VII) the short-term and long-term consequences of the injury;
(VIII) other factors that may cause injury to the human body.
Article 13. Depending on the severity of the medical device defect, medical device recalls are classified as:
(I) Grade I recall: where the use of the medical device may or already has caused serious health hazards;
(II) Grade II recall: where the use of the medical device may or already has caused temporary or reversible health hazards;
(III) Grade III recall: where the use of the medical device is less likely to cause hazards but a recall is still necessary.
Medical device manufacturing enterprises shall determine the recall grade according to the specific circumstances and, based on the recall grade and the sales and use of the medical device, scientifically design the recall plan and organize its implementation.
Chapter 3 Voluntary Recall
Article 14. Where a medical device manufacturing enterprise, after conducting investigation and assessment in accordance with the requirements of Articles 10 and 12 of these Measures, determines that a medical device product is defective, it shall immediately decide on and implement a recall and simultaneously disclose the product recall information to the public.
For a Grade I recall, the medical device recall announcement shall be published on the website of the China Food and Drug Administration and in the main central media; for a Grade II or Grade III recall, the medical device recall announcement shall be published on the website of the food and drug administration department of the province, autonomous region or municipality directly under the Central Government, and the recall announcement published on the website of such food and drug administration department shall be linked to the website of the China Food and Drug Administration.
Article 15. Where a medical device manufacturing enterprise makes a decision to recall a medical device, it shall notify the relevant medical device distribution enterprises and using entities, or inform the users, within 1 day for a Grade I recall, within 3 days for a Grade II recall, and within 7 days for a Grade III recall.
The recall notice shall include the following contents:
(I) basic information on the recalled medical device, such as its name, model and specifications, and batch;
(II) the reason for the recall;
(III) the requirements of the recall, such as immediately suspending the sale and use of the product and forwarding the recall notice to the relevant distribution enterprises or using entities;
(IV) the manner of handling the recalled medical device.
Article 16. Where a medical device manufacturing enterprise makes a decision to recall a medical device, it shall immediately submit a medical device recall incident report form to the food and drug administration department of the province, autonomous region or municipality directly under the Central Government where it is located and to the food and drug administration department that approved the registration or handled the filing of the product, and shall, within 5 working days, submit the investigation and assessment report and the recall plan for filing to the food and drug administration department of the province, autonomous region or municipality directly under the Central Government where it is located and to the food and drug administration department that approved the registration or handled the filing.
The food and drug administration department of the province, autonomous region or municipality directly under the Central Government where the medical device manufacturing enterprise is located shall, within 1 working day of receiving the recall incident report form, report the relevant circumstances of the recall to the China Food and Drug Administration.
Article 17. The investigation and assessment report shall include the following contents:
(I) the specific circumstances of the recalled medical device, including basic information such as its name, model and specifications, and batch;
(II) the reason for implementing the recall;
(III) the results of the investigation and assessment;
(IV) the recall grade.
The recall plan shall include the following contents:
(I) the production and sales situation of the medical device and the quantity to be recalled;
(II) the specific content of the recall measures, including the organization, scope and time limit for implementation;
(III) the channels and scope for disclosing the recall information;
(IV) the expected effect of the recall;
(V) the handling measures after the medical device recall.
Article 18. The food and drug administration department of the province, autonomous region or municipality directly under the Central Government where the medical device manufacturing enterprise is located may assess the recall plan submitted by the manufacturing enterprise; where it considers that the measures taken by the manufacturing enterprise cannot effectively eliminate the product defects or control the product risks, it shall require the enterprise in writing to take more effective measures, such as raising the recall grade, expanding the recall scope, shortening the recall time, or changing the manner of handling the recalled product. The medical device manufacturing enterprise shall revise the recall plan in accordance with the requirements of the food and drug administration department and organize its implementation.
Article 19. Where a medical device manufacturing enterprise modifies the recall plan it has reported, it shall promptly report the same for filing to the food and drug administration department of the province, autonomous region or municipality directly under the Central Government where it is located.
Article 20. In the course of implementing a recall, a medical device manufacturing enterprise shall, in accordance with the recall plan, periodically submit reports on the implementation of the recall plan to the food and drug administration department of the province, autonomous region or municipality directly under the Central Government where it is located.
Article 21. A medical device manufacturing enterprise shall keep detailed records of the handling of the recalled medical device and report to the food and drug administration department of the province, autonomous region or municipality directly under the Central Government where it is located; the records shall be retained until 5 years after the medical device registration certificate becomes invalid, and the handling records of a Class I medical device recall shall be retained for 5 years. Where the product defects can be eliminated by means of warning, inspection, repair, relabeling, modifying and improving the instructions, software updating, replacement, destruction or other methods, the foregoing acts may be completed at the place where the product is located. Where destruction is necessary, it shall be carried out under the supervision of the food and drug administration department.
Article 22. A medical device manufacturing enterprise shall, within 10 working days after the completion of the recall, assess the recall effect and submit a summary assessment report on the medical device recall to the food and drug administration department of the province, autonomous region or municipality directly under the Central Government where it is located.
Article 23. The food and drug administration department of the province, autonomous region or municipality directly under the Central Government where the medical device manufacturing enterprise is located shall, within 10 working days from the date of receiving the summary assessment report, review the report and assess the recall effect; where it considers that the recall has not yet effectively eliminated the product defects or controlled the product risks, it shall require the manufacturing enterprise in writing to carry out a re-recall. The medical device manufacturing enterprise shall carry out the re-recall in accordance with the requirements of the food and drug administration department.
Chapter 4 Ordered Recall
Article 24. Where the food and drug administration department, after investigation and assessment, considers that a medical device manufacturing enterprise should recall a defective medical device product but has not taken the initiative to recall it, it shall order the medical device manufacturing enterprise to recall the medical device.
The decision to order a recall may be made by the food and drug administration department of the province, autonomous region or municipality directly under the Central Government where the medical device manufacturing enterprise is located, or by the food and drug administration department that approved the registration or handled the filing of the medical device. The food and drug administration department that makes the decision shall disclose the ordered-recall information to the public on its website.
The medical device manufacturing enterprise shall carry out the recall in accordance with the requirements of the food and drug administration department, and shall disclose the product recall information to the public in accordance with the provisions of the second paragraph of Article 14 of these Measures.
Where necessary, the food and drug administration department may require medical device manufacturing enterprises, distribution enterprises and using entities to immediately suspend production, sale and use, and inform users to immediately suspend the use of the defective product.
Article 25. Where the food and drug administration department makes a decision to order a recall, it shall serve the ordered-recall notice on the medical device manufacturing enterprise. The notice shall include the following contents:
(I) the specific circumstances of the recalled medical device, including basic information such as its name, model and specifications, and batch;
(II) the reason for implementing the recall;
(III) the results of the investigation and assessment;
(IV) the recall requirements, including the scope and time limit.
Article 26. After receiving the ordered-recall notice, the medical device manufacturing enterprise shall notify the medical device distribution enterprises and using entities or inform the users in accordance with the provisions of Articles 15 and 16 of these Measures, formulate and submit a recall plan, and organize its implementation.
Article 27. A medical device manufacturing enterprise shall report the relevant circumstances of the medical device recall to the food and drug administration department in accordance with the provisions of Articles 19, 20, 21 and 22 of these Measures, and carry out the follow-up handling of the recalled medical device.
The food and drug administration department shall, in accordance with the provisions of Article 23 of these Measures, review the summary assessment report on the medical device recall submitted by the medical device manufacturing enterprise and evaluate the recall effect, and shall, where necessary, notify the health administration department at the same level. Where, after review and evaluation, it considers that the recall is incomplete and has not yet effectively eliminated the product defects or controlled the product risks, the food and drug administration department shall require the medical device manufacturing enterprise in writing to carry out a re-recall. The medical device manufacturing enterprise shall carry out the re-recall in accordance with the requirements of the food and drug administration department.
Chapter 5 Legal Liability
Article 28. Where a medical device manufacturing enterprise, due to a violation of the provisions of laws, regulations or rules, causes a marketed medical device to be defective and an administrative penalty should be imposed in accordance with the law, but the enterprise has already taken recall measures to take the initiative to eliminate or mitigate the harmful consequences, the food and drug administration department shall, in accordance with the provisions of the Administrative Penalty Law of the People’s Republic of China, impose a lighter or mitigated penalty; where the illegal act is minor and is corrected in time without causing harmful consequences, no penalty shall be imposed.
The recall of a medical device by a medical device manufacturing enterprise shall not exempt it from other legal liability that it should bear in accordance with the law.
Article 29. Where a medical device manufacturing enterprise, in violation of the provisions of Article 24 of these Measures, refuses to recall a medical device, the matter shall be handled in accordance with the provisions of Article 66 of the Regulation on the Supervision and Administration of Medical Devices.
Article 30. Where a medical device manufacturing enterprise falls under any of the following circumstances, it shall be given a warning and ordered to make corrections within a time limit, and shall be fined not more than RMB 30,000:
(I) failing, in violation of the provisions of Article 14 of these Measures, to promptly disclose the product recall information to the public as required;
(II) failing, in violation of the provisions of Article 15 of these Measures, to notify the decision to recall the medical device to the medical device distribution enterprises and using entities, or to inform the users, within the prescribed time;
(III) failing, in violation of the provisions of Article 18, Article 23, or the second paragraph of Article 27 of these Measures, to take corrective measures or carry out a re-recall of the medical device as required by the food and drug administration department;
(IV) failing, in violation of the provisions of Article 21 of these Measures, to keep detailed records of the handling of the recalled medical device or to report to the food and drug administration department.
Article 31. Where a medical device manufacturing enterprise falls under any of the following circumstances, it shall be given a warning and ordered to make corrections within a time limit; where it fails to make corrections within the time limit, it shall be fined not more than RMB 30,000:
(I) failing to establish a medical device recall management system in accordance with the provisions of these Measures;
(II) refusing to cooperate with the investigation carried out by the food and drug administration department;
(III) failing to submit the medical device recall incident report form, the investigation and assessment report and recall plan, or the report on the implementation of the medical device recall plan and the summary assessment report, in accordance with the provisions of these Measures;
(IV) modifying the recall plan without reporting it for filing to the food and drug administration department.
Article 32. Where a medical device distribution enterprise or using entity violates the provisions of the first paragraph of Article 7 of these Measures, it shall be ordered to suspend the sale or use of the defective medical device and shall be fined not less than RMB 5,000 but not more than RMB 30,000; where serious consequences are caused, the original certificate-issuing department shall revoke the Medical Device Distribution License.
Article 33. Where a medical device distribution enterprise or using entity refuses to cooperate with the investigation of the relevant medical device defects or refuses to assist the medical device manufacturing enterprise in recalling the medical device, it shall be given a warning and ordered to make corrections within a time limit; where it refuses to make corrections within the time limit, it shall be fined not more than RMB 30,000.
Article 34. Where the food and drug administration department and its staff fail to perform their medical device supervision and administration duties or abuse their power or neglect their duties, and fall under any of the following circumstances, the supervisory organ or the appointment-and-removal organ shall, depending on the severity of the circumstances, give criticism and education to, or give a warning, demerit or serious demerit to, the directly responsible person-in-charge and other directly liable persons in accordance with the law; where serious consequences are caused, a sanction of demotion, removal from office or dismissal shall be given:
(I) failing to disclose the recall information to the public as prescribed;
(II) failing to report or notify the relevant recall information to the relevant departments as prescribed;
(III) failing to take ordered-recall measures where an ordered recall should have been made;
(IV) failing, in violation of the provisions of Article 23 and the second paragraph of Article 27 of these Measures, to urge the medical device manufacturing enterprise to effectively implement the recall.
Chapter 6 Supplementary Provisions
Article 35. Where a recalled medical device has already been implanted in the human body, the medical device manufacturing enterprise shall consult jointly with the medical institution and the patient and, depending on the different reasons for the recall, put forward handling opinions for the patient and the contingency measures that should be taken.
Article 36. Where a recalled medical device causes harm to a patient, the patient may claim compensation from the medical device manufacturing enterprise, or may claim compensation from the medical device distribution enterprise or using entity. Where the patient claims compensation from the medical device distribution enterprise or using entity, the medical device distribution enterprise or using entity shall, after making compensation, have the right to seek recovery from the responsible medical device manufacturing enterprise.
Article 37. These Measures shall come into force on May 1, 2017. The Measures for the Administration of Medical Device Recall (for Trial Implementation) (Order No. 82 of the Ministry of Health of the People’s Republic of China), which came into force on July 1, 2011, shall be repealed simultaneously.