Provisions for Administration of Medical Device Recall

Provisions for Administration of Medical Device Recall

(Promulgated by Decree No. 29 of the China Food and Drug Administration on January 25, 2017, these Provisions shall be effective as of May 1, 2017.)

Chapter I General Provisions

Article 1These Provisions are formulated in accordance with theRegulations on Supervision and Administration of Medical Devicesfor the purpose of strengthening the supervision and administration of medical devices, controlling defective medical device products, eliminating potential safety hazards of medical devices, ensuring the safety and effectiveness of medical devices, and safeguarding human health and the safety of people’s lives.

Article 2These Provisions shall apply to the recall, supervision and administration of marketed medical devices within the territory of the People's Republic of China.

Article 3The recall of medical devices in these Provisions refers to the handling acts of medical device manufacturers to the defective medical device products of a certain category, model or batch which have gone to the market through warning, checking, repair, relabeling, modifying and improving the instructions for use, software upgrade, replacement, withdrawal, destruction in accordance with the prescribed procedures.

The medical device manufacturers mentioned in the preceding paragraph refer to the registrants or filing entities of the domestic medical device products, and the agents appointed by the overseas manufacturer of imported medical devices within the territory of China.

Article 4The defective medical device products mentioned in these Provisions include:

(1) products with unreasonable risks that may cause hazards to human health and life safety under normal use;

(2) products that do not comply with mandatory standards, and the registered or filed technical specifications for the products;

(3) products that do not comply with relevant regulations on the manufacturing and distribution quality management of medical devices, resulting in unreasonable risks that may exist;

(4) other products that need to be recalled.

Article 5The medical device manufacturers are liable entities for controlling and eliminating product defects, and shall take the initiative to recall the defective products.

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

The agent appointed by the overseas manufacturer of imported medical devices within the territory of China shall, in a timely manner, report relevant information of the recall of medical devices implemented only overseas to the China Food and Drug Administration; for any recall within the territory of China, the agent appointed within the territory of China shall organize and implement the recall in accordance with these Provisions.

The medical device distributors and using units shall actively assist the medical device manufacturers in investigating and assessing defective products, voluntarily cooperate with manufacturers to fulfill recall obligations, transmit information, and provide feedback on recall of medical devices in accordance with the recall plan in a timely manner, control and take back the defective products.

Article 7Upon finding that the medical device it sells and uses may be a detective product, the medical device distributor or using unit shall immediately suspend the sale or use of the medical device, notify the medical device manufacturer or supplier in a timely manner, and report the findings to the food and drug regulatory department of the province, autonomous region, or municipality directly under the Central Government where it is located; if the using unit is a medical institution, it shall also report the findings 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 regulatory department of the province, autonomous region, or municipality directly under the Central Government where the medical device distributor or using unit is located shall, in a timely manner, inform the food and drug regulatory department of the province, autonomous region, or municipality directly under the Central Government where the medical device manufacturer is located.

Article 8The food and drug regulatory department of the province, autonomous region and municipality directly under the Central Government where the manufacturer of the recalled medical device is located shall be responsible for the supervision and administration of the recall, and the food and drug regulatory departments of other provinces, autonomous regions and municipalities directly under the Central Government shall cooperate in the recall of medical devices within their respective administrative areas.

The China Food and Drug Administration shall supervise the management of medical device recall nationwide.

Article 9The China Food and Drug Administration and the food and drug regulatory departments of provinces, autonomous regions, and municipalities directly under the Central Government shall, in accordance with relevant medical device recall information notification and information disclosure systems, disclose information about the defective products and recall of medical devices to the society in an effective way, and when necessary, inform the relevant information to the health administration department at the same level.

Chapter II Investigation and Assessment of Medical Device Defects

Article 10The medical device manufacturers shall establish and improve a medical device quality management system as well as a medical device adverse events monitoring system in accordance with regulations, collect and record medical device quality complaint information and medical device adverse events information, analyze the collected information, and investigate and assess possible defects.

The medical device distributors and using units shall cooperate with medical device manufacturers to investigate the defects of relevant medical devices and provide relevant data.

Article 11The medical device manufacturers shall, in a timely manner, report the collected information on adverse events of medical devices to the food and drug regulatory department in accordance with regulations, and the food and drug regulatory department may analyze and investigate the adverse events or possible defects of medical devices; the medical device manufacturers, distributors and using units shall provide cooperation.

Article 12The main contents of the assessment of a defective medical device product include:

(1) whether the product complies with mandatory standards, and the registered or filed technical specifications for the product;

(2) whether any malfunction or injury occurred during the use of the medical device;

(3) whether it would cause injury under the existing use environment, and whether there are scientific literatures, researches, relevant tests, or verifications that can explain the cause of the injury;

(4) the scope of region and the characteristics of the population involved in the injury;

(5) the severity of injury to human health;

(6) the probability of injury;

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

(8) other factors that may cause injury to the human body.

Article 13According to the severity of medical device defects, medical device recalls are divided into:

(1) Class I recalls: the use of the medical device may cause or has caused serious hazards to health;

(2) Class II recalls: the use of the medical device may cause or has caused temporary or reversible hazards to health;

(3) Class III recalls: the use of the medical device is less likely to cause hazard but the device still needs to be recalled.

The medical device manufacturers shall confirm the recall class according to the specific situation, and scientifically devise the recall plan and organize its implementation according to the recall class and the sales and use of the medical device.

Chapter III Voluntary Recall

Article 14After the medical device manufacturer carries out an investigation and assessment in accordance with the requirements of Articles 10 and 12 of these Provisions, if it is confirmed that the medical device product is defective, it shall immediately decide and implement a recall, and disclose the product recall information to the society.

If a Class I recall is implemented, the medical device recall announcement shall be published on the website of the China Food and Drug Administration and the major media of the Central Government; if a Class II or III recall is implemented, the medical device recall announcement shall be published on the food and drug regulatory department of the province, autonomous region, and municipality directly under the Central Government. The recall announcement published on the website of the food and drug regulatory department of the province, autonomous region, or municipality directly under the central government shall be linked to the website of the China Food and Drug Administration.

Article 15If a medical device manufacturer makes a decision to recall a medical device, it shall notify such decision to the relevant medical device distributors, using units or inform the users within 1 day for Class I recall, within 3 days for Class II recall, and within 7 days for Class III recall.

The recall notice shall include the following items:

(1) basic information of the recalled medical device, such as the product name, model, specification, batch, etc.;

(2) the causes of the recall;

(3) recall requirements, such as immediately suspending the sale and use of the product, forwarding the recall notice to relevant distributors or using units, etc.;

(4) handling measures of the recalled medical devices.

Article 16If a medical device manufacturer makes a decision to recall a medical device, it shall immediately submit a medical device recall event report form to the food and drug regulatory department of the province, autonomous region, or municipality directly under the Central Government where it is located and the food and drug regulatory department approving the registration or undertaking the filing of the product; and submit the investigation and assessment report as well as the recall plan to the food and drug regulatory department of the province, autonomous region, or municipality directly under the Central Government where it is located and the food and drug regulatory department approving the registration or undertaking the filing of the product for filing within 5 working days.

The food and drug regulatory department of the province, autonomous region, or municipality directly under the Central Government where the medical device manufacturer is located shall report the relevant situation of the recall to the China Food and Drug Administration within 1 working day after receiving the recall event report form.

Article 17The investigation and assessment report shall include the following items:

(1) the specific information of the recalled medical device, including product name, model, specification, batch, etc. ;

(2) the causes of the recall;

(3) the investigation and assessment results;

(4) the class of the recall.

The recall plan shall include the following items:

(1) the manufacturing and sales of medical devices and the quantity to be recalled;

(2) the specific details of the recall measures, including the organization, scope, and time limit of implementation, etc.;

(3) the way and scope of disclosing of the recall information;

(4) the expected result of the recall;

(5) handling measures of the post-recall of medical devices.

Article 18The food and drug regulatory department of the province, autonomous region, or municipality directly under the Central Government where the medical device manufacturer is located may assess the recall plan submitted by the manufacturer, and if it considers that the measures taken by the manufacturer cannot effectively eliminate product defects or control product risks, it shall notify the manufacture in written form to require it to take more effective handling measures, such as raising the recall class, expanding the recall scope, shortening the recall time or changing the handling method of the recalled products. The medical device manufacturers shall revise the recall plan and organize the implementation in accordance with the requirements of the food and drug regulatory department.

Article 19A medical device manufacturer who makes changes to the submitted recall plan shall, in a timely manner, report to the food and drug regulatory department of the province, autonomous region or municipality directly under the Central Government where it is located for filing.

Article 20During the recall process, the medical device manufacturer shall, according to the recall plan, regularly submit a report on the implementation of the recall plan to the food and drug regulatory department of the province, autonomous region, and municipality directly under the central government where it is located.

Article 21The medical device manufacturer shall keep detailed records on the handling of recalled medical devices, and report to the food and drug regulatory department of the province, autonomous region or municipality directly under the Central Government where the medical device manufacturer is located. The records shall be kept up to 5 years after the expiration of the Medical Device Registration Certificate, and the handling records of the recall of Class I medical devices shall be kept for 5 years. Where product defects can be eliminated by warning, checking, repairing, relabeling, modifying and improving the instructions for use, software upgrade, replacement, and destruction, the above actions may be completed at the location of the product. The medical devices that need to be destroyed shall be destroyed under the supervision of the food and drug regulatory department.

Article 22The medical device manufacturer shall assess the recall effect within 10 working days after the completion of recall, and submit a medical device recall summary evaluation report to the food and drug regulatory department of the province, autonomous region, or municipality directly under the Central Government where it is located.

Article 23The food and drug regulatory department of the province, autonomous region, or municipality directly under the Central Government where the medical device manufacturer is located shall review the summary evaluation report within 10 working days from the date of receipt of the report, and assess the recall effect; if it considers that the recall has not effectively eliminated product defects or control product risks, it shall notify the manufacturer in written form to require it to make another round of recall. The medical device manufacturers shall make another round of recall in accordance with the requirements of the food and drug regulatory department.

Chapter IV Ordered Recall

Article 24After investigation and assessment, if the food and drug regulatory department considers that the medical device manufacturer shall recall defective medical device products but has not taken the initiative to recall them, it shall order the medical device manufacturer to recall the medical devices.

The decision on ordered recall can be made by the food and drug regulatory department of the province, autonomous region, or municipality directly under the Central Government where the medical device manufacturer is located, or by the food and drug regulatory department approving the registration or undertaking filing of the medical device. The food and drug regulatory department which makes such decision shall disclose the ordered recall information to the society on its website.

The medical device manufacturer shall recall in accordance with the requirements of the food and drug regulatory department, and disclose the product recall information to the society in accordance with Paragraph 2, Article 14 of these Provisions.

When necessary, the food and drug regulatory department may require the medical device manufacturers, distributors, and using units to immediately suspend the manufacture, sale and use, and inform the users to immediately suspend the use of the defective products.

Article 25When the food and drug regulatory department makes a decision on ordered recall, it shall send the notice of ordered recall to the medical device manufacturer, and the notice shall include the following items:

(1) the specific information of the recalled medical device, including product name, model, specification, batch, etc.

(2) the causes of the recall;

(3) the investigation and assessment results;

(4) recall requirements, including scope and time limit, etc.

Article 26After receiving the ordered recall notice, the medical device manufacturer shall notify the medical device distributors and using units or inform the users in accordance with Article 15 and Article 16 of these Provisions, formulate and submit a recall plan, and organize its implementation.

Article 27The medical device manufacturers shall report the relevant situation of medical device recall to the food and drug regulatory department, and carry out subsequent handling of recalled medical devices in accordance with Article 19, 20, 21 and 22 of these Provisions.

The food and drug regulatory department shall, in accordance with Article 23 of these Provisions, review the medical device recall summary evaluation report submitted by the medical device manufacturer, evaluate the recall effect, and inform the health administration department at the same level if necessary. If the review and evaluation conclude that the recall is inexhaustive and has not effectively eliminated product defects or controlled product risks, the food and drug regulatory department shall notify the medical device manufacturer in written form to require it to make another round of recall. The medical device manufacturer shall make another round of recall in accordance with the requirements of the food and drug regulatory department.

Chapter V Legal Liability

Article 28If a medical device manufacturer violates laws, regulations and rules and causes defects in the marketed medical devices, administrative penalties shall be imposed according to law. For the manufacturer who has taken recall measures to initiatively eliminate or reduce the harmful consequences, the food and drug regulatory department shall impose a lighter or mitigated penalty according to theLaw of the People's Republic of China on Administrative Penalty; for the manufacturer who has committed minor violations and made prompt corrections but has not caused any serious consequences, the punishment shall be exempted.

A medical device manufacturer who has recalled its medical devices shall not be exempted from other legal liabilities that it shall bear according to law.

Article 29If a medical device manufacturer violates Article 24 of these Provisions and refuses to recall the medical devices, the Provisions of Article 66 of theRegulations on Supervision and Administration of Medical Devicesshall apply.

Article 30In one of the following circumstances, the medical device manufacturer shall be warned and ordered to rectify the situation within a time limit, and a fine of not more than 30,000 Yuan shall be imposed concurrently:

(1) fail to disclose the product recall information to the society in a timely manner as required, which violates Article 14 of these Provisions;

(2) fail to notify the medical device distributors, using units or inform the users of the decision to recall medical devices within the specified time, which violates Article 15 of these Provisions;

(3) fail to take corrective measures or make another round of medical devices recall according to the requirements of the food and drug regulatory department, which violates Article 18, Article 23, and Paragraph 2 of Article 27 of these Provisions;

(4) fail to make detailed handling records of the recalled medical devices or fail to report the results to the food and drug regulatory department, which violates Article 21 of these Provisions.

Article 31In one of the following circumstances, the medical device manufacturer shall be warned and ordered to rectify the situation within a time limit; if it fails to rectify within the time limit, a fine of not more than 30,000 Yuan shall be imposed:

(1) fail to establish a medical device recall management system in accordance with these Provisions;

(2) refuse to cooperate with the food and drug regulatory department in carrying out an investigation;

(3) fail to submit the medical device recall event report form, investigation and assessment report and recall plan, implementation of the medical device recall plan and summary evaluation report in accordance with these Provisions;

(4) fail to report the changes of the recall plan to the food and drug regulatory department for filing.

Article 32A medical device distributor or using unit that violates the Provisions of the Paragraph 1, Article 7 of these Provisions shall be ordered to stop the sale and use of defective medical devices, and a fine of not less than 5,000 Yuan but not more than 30,000 Yuan shall be imposed concurrently; for those who have caused serious consequences, the former license issuing department shall revoke theirMedical Device Distribution License.

Article 33A medical device distributor or using unit that refuses to cooperate in relevant medical device defect investigation or refuses to assist the medical device manufacturer in recalling the medical device shall be warned and ordered to rectify the situation within a time limit; if it fails to do so within the time limit, a fine of not more than 30,000 Yuan shall be imposed.

Article 34The food and drug regulatory departments and their personnel who fail to perform their responsibilities for medical device supervision and administration, or abuse their powers or neglect their duties, in any of the following circumstances, the supervisory authority or the appointment and dismissal authority shall, according to the seriousness of the circumstances, give criticism and education, or give warning, demerit or major demerit to the persons directly in charge and other directly responsible persons according to law; if serious consequences are caused, demotion, removal or dismissal shall be given:

(1) fail to disclose the recall information to the society as required;

(2) fail to report or inform relevant recall information to relevant departments as required;

(3) fail to take ordered recall measures in circumstances where ordered recall is required;

(4) fail to urge the medical device manufacturer to effectively implement the recall, which violates Article 23 and the Paragraph 2 of Article 27 of these Provisions.

Chapter VI Supplementary Provisions

Article 35If the recalled medical device has been implanted into the human body, the medical device manufacturer shall negotiate with the medical institution and the patient, and put forward the treatment suggestions for the patient and the measures to be taken according to the different causes of the recall.

Article 36If the recalled medical device has caused injury to a patient, the patient may claim compensation from the medical device manufacturer, or from the medical device distributor or using unit. If the patient claims compensation from the medical device distributor or using unit, the medical device distributor or using unit has the right to recover compensation from the responsible medical device manufacturer after making such compensation.

Article 37These Provisions shall be effective as of May 1, 2017. TheProvisions for Administration of Medical Device Recall (Trial)(Decree No. 82 of the Ministry of Health of the People's Republic of China), which came into effect on July 1, 2011, shall be repealed simultaneously.

Note: In case of any difference in interpretation between the English version and the Chinese version, the Chinese version shall prevail.