Shen Yang Bokan Biotechnology Co.,Ltd
Shenyang Baokang Bioengineering Co., Ltd

Administrative measures for recall of medical devices (Trial)


Administrative measures for recall of medical devices (Trial)




Chapter I General Provisions


Article 1 These measures are formulated in accordance with the regulations on the supervision and administration of medical devices and the special provisions of the State Council on strengthening the supervision and administration of food and other products in order to strengthen the supervision and administration of medical devices and ensure human health and life safety.


Article 2 These Measures shall apply to the recall and supervision and administration of medical devices sold within the territory of the people's Republic of China.


Article 3 the recall of medical devices as mentioned in these Measures refers to the actions of the medical device manufacturer to eliminate the defects of a certain category, model or batch of products that have defects on the market in accordance with the prescribed procedures by means of warning, inspection, repair, relabeling, modification and improvement of instructions, software upgrading, replacement, recall, destruction, etc.


Article 4 the defects mentioned in these Measures refer to the unreasonable risks that may endanger human health and life safety of medical devices under normal use.


Article 5 medical device manufacturers are the main body to control and eliminate product defects, and shall be responsible for the safety of the products they produce.


Article 6 the manufacturer of medical devices shall establish and improve the recall system of medical devices in accordance with the provisions of these measures, collect relevant information on the safety of medical devices, investigate and evaluate the medical devices that may have defects, and recall the defective medical devices in time.


The medical device business enterprises and users shall assist the medical device manufacturers to fulfill the recall obligations, timely convey and feed back the recall information of medical devices according to the requirements of the recall plan, and control and recover the defective medical devices.


Article 7 If a medical device business enterprise or user finds that the medical device it operates or uses has defects, it shall immediately suspend the sale or use of the medical device, timely notify the medical device manufacturer or supplier, and report to the drug regulatory department of the province, autonomous region or municipality directly under the central government where it is located; if the user is a medical institution, it shall also report to the province or municipality where it is located at the same time Report of the administrative department of public health of the municipality directly under the central government.


After receiving the report, the drug regulatory department of the province, autonomous region or municipality directly under the central government where the medical device manufacturer or user is located shall timely notify the drug regulatory department of the province, autonomous region or municipality directly under the central government where the medical device manufacturer is located.


Article 8 The pharmaceutical supervisory and administrative departments of the provinces, autonomous regions and municipalities directly under the central government where the manufacturing enterprises of recalled medical devices and the overseas manufacturers of imported medical devices appoint their agents within the territory of China shall be responsible for the supervision and administration of the recall of medical devices. The pharmaceutical supervisory and administrative departments of other provinces, autonomous regions and municipalities directly under the central government shall cooperate and assist in the recall of medical devices within their respective jurisdictions.


The State Food and drug administration supervises the management of recall of medical devices nationwide.


Article 9 the State Food and Drug Administration and the drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the central government shall establish a system for notification and disclosure of recall information of medical devices, timely report relevant information to the health administration departments at the same level, and take effective ways to publicize the defective medical device information and recall information of medical devices to the society.




Chapter II investigation and evaluation of medical device defects


Article 10 medical device manufacturers shall establish and improve the quality management system and adverse event monitoring system of medical devices, collect and record the quality problems and adverse event information of medical devices, analyze the collected information, and investigate and evaluate the possible defects of medical devices.


The medical device business enterprises and users shall cooperate with the medical device manufacturers to carry out the investigation on the defects of the medical devices and provide relevant information.


Article 11 the manufacturer of medical devices shall timely report the collected information of adverse events of medical devices to the drug regulatory department in accordance with the regulations. The drug regulatory department may analyze and investigate the information of adverse events of medical devices or the possible defects, and the manufacturer, business enterprise and user of medical devices shall provide assistance.


Article 12 the main contents of the assessment of the defects of medical devices include:


(1) Whether there is any fault or injury during the use of medical devices;


(2) Whether it will cause injury in the existing use environment, whether there is scientific literature, research, relevant tests or verification that can explain the cause of injury;


(3) The area and population characteristics of the injury;


(4) The degree of harm to human health;


(5) Probability of injury;


(6) The short-term and long-term consequences of injury;


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


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


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


(2) Secondary recall: the use of the medical device may or has caused temporary or reversible health hazards;


(3) Third level recall: the use of the medical device is less likely to cause harm but still needs to be recalled.


The manufacturer of medical devices shall scientifically design and organize the implementation of the recall plan according to the recall classification and the sales and use of medical devices.

 

Chapter III active recall


Article 14 after the medical device manufacturer conducts investigation and evaluation in accordance with the requirements of Articles 10 and 12 of these measures, if it finds any defect in the medical device, it shall immediately decide to recall it.


If an overseas manufacturer of imported medical devices carries out a recall of medical devices abroad, it shall notify its designated agent in China to report to the State Food and Drug Administration in a timely manner; if it carries out a recall in China, its designated agent in China shall be responsible for the specific implementation in accordance with the provisions of these measures.


Article 15 If a medical device manufacturer makes a decision on the recall of medical devices, the first level recall shall be within one day, the second level recall shall be within three days, and the third level recall shall be within seven days, and the relevant medical device business enterprise, user unit or user shall be notified.


The recall notice shall at least include the following contents:


(1) Name, batch and other basic information of recalled medical devices;


(2) Reasons for recall;


(3) Recall requirements: such as immediately suspending the sale and use of the product, forwarding the recall notice to the relevant business enterprise or user, etc;


(4) Handling methods of recalled medical devices.


Article 16 If a medical device manufacturer makes a decision on recall of medical devices, it shall immediately notify the drug regulatory department of the province, autonomous region or municipality directly under the central government where it is located in writing, and fill in the report form of recall of medical devices (see attached table 1) within 5 days, and submit the investigation and evaluation report and recall plan to the drug regulatory department of the province, autonomous region or municipality directly under the central government where it is located for filing.


The drug regulatory departments of provinces, autonomous regions and municipalities directly under the central government shall report the relevant information of the first-class recall to the State Food and Drug Administration in a timely manner.


Article 17 An Investigation and evaluation report shall include the following contents:


(1) Specific conditions of recalled medical devices, including basic information such as name, batch, etc;


(2) Reasons for the implementation of the recall;


(3) Investigation and evaluation results;


(4) Recall classification.


The recall plan shall include the following contents:


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


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


(3) The way and scope of releasing recall information;


(4) Expected effect of recall;


(5) Treatment measures after recall of medical devices.


Article 18 The pharmaceutical supervisory and administrative department may organize experts to evaluate the recall plan submitted by the medical device manufacturer according to the actual situation. If the measures taken by the medical device manufacturer cannot effectively eliminate the defects, the pharmaceutical supervisory and administrative department shall require the medical device manufacturer to improve the recall level, expand the recall scope, shorten the recall time or change the handling method of the recalled products It is an effective measure.


Article 19 Where a medical device manufacturer changes the reported recall plan, it shall timely report to the drug regulatory department for filing.


Article 20 in the process of implementing the recall, the medical device manufacturer shall regularly submit the report on the implementation of the recall plan (see attached table 2) to the drug regulatory department according to the recall plan, and report on the implementation of the recall plan.


Article 21 a medical device manufacturer shall have detailed records on the handling of recalled medical devices and report to the drug regulatory department of the province, autonomous region or municipality directly under the central government where the medical device manufacturer is located. For those who can eliminate product defects through warning, inspection, repair, relabeling, modification and improvement of instructions, software upgrading, replacement, destruction, etc., the above behaviors can be completed at the product location. If it is necessary to destroy it, it shall be destroyed under the supervision of the drug regulatory department in the place where it is destroyed.


Article 22 after the recall is completed, the manufacturer of medical devices shall evaluate the recall effect and submit the recall summary report to the drug regulatory department within 10 days after the recall is completed.


Article 23 the drug regulatory department shall review the report and evaluate the recall effect within 10 days after receiving the summary report. The conclusion of examination and evaluation shall be notified to the medical device manufacturer in written form and copied to the health administrative department at the same level.


After examination and evaluation, if it is found that the recall is not complete and the defect has not been effectively eliminated, the drug regulatory department shall require the medical device manufacturer to recall again.

 

Chapter IV order for recall


Article 24 after investigation and evaluation, the drug regulatory department shall order the medical device manufacturer to recall the medical device if it considers that there are defects mentioned in Article 4 of these measures, and the medical device manufacturer shall recall the medical device without initiative recall.


When necessary, the pharmaceutical supervisory and administrative department shall require the medical device manufacturers, trading enterprises and users to immediately suspend the sale or use of the medical device, and inform the users to immediately suspend the use of the medical device.


Article 25 when the pharmaceutical supervisory and administrative department makes the decision of ordering the recall, it shall send the notice of ordering the recall to the medical device manufacturer or the domestic agent of the imported medical device manufacturer. The notice shall include the following contents:


(1) Specific conditions of recalled medical devices, including basic information such as name, batch, etc;


(2) Reasons for the implementation of the recall;


(3) Investigation and evaluation results;


(4) Recall requirements, including scope, time limit, etc.


Article 26 after receiving the notice of ordering recall, the medical device manufacturer shall, in accordance with the provisions of Articles 15 and 16 of these measures, notify the medical device operation enterprise and user or inform the user, formulate and submit the recall plan, and organize the implementation.


Article 27 the manufacturer of medical devices shall report the recall of medical devices to the drug regulatory authority in accordance with the provisions of articles 19, 20, 21 and 22 of these measures, and carry out the follow-up treatment of the recall of medical devices.


The pharmaceutical supervisory and administrative department shall, in accordance with the provisions of Article 23 of these measures, review the summary report on the recall of medical devices submitted by the medical device manufacturer, evaluate the recall effect and timely notify the health administrative department at the same level. After examination and evaluation, if it is found that the recall is not complete and the defect has not been effectively eliminated, the drug regulatory department shall require the medical device manufacturer to recall again.




Chapter V Legal Liability


Article 28 If the pharmaceutical supervisory and administrative department confirms that the medical device manufacturing enterprise has defects in the listed medical device due to violation of laws, regulations and rules, it shall be given administrative punishment according to law, but if the enterprise has taken recall measures to eliminate or mitigate the harmful consequences, it shall be given a lighter or mitigated punishment according to the provisions of the administrative punishment law; if the illegal act is minor, it shall be corrected in time, and it has not No punishment shall be given to those who cause harmful consequences.


If a medical device manufacturer recalls medical devices, it shall not be exempted from other legal liabilities it shall bear according to law.


Article 29 If a medical device manufacturer, in violation of the provisions of these measures, finds defects in the medical device and fails to recall the medical device, it shall be ordered to recall the medical device and imposed a fine of 3 times the value of the recalled medical device. If serious consequences are caused, the original license issuing department shall revoke the registration certificate of the medical device product until the license of the medical device manufacturer is revoked.


Article 30 If a medical device manufacturer refuses to recall the medical device in violation of the provisions of Article 24 of these measures, it shall be fined 3 times of the value of the recalled medical device; if serious consequences are caused, the original license issuing department shall revoke the registration certificate of the medical device product, or even revoke the license of the medical device manufacturer.


Article 31 in case of any of the following circumstances, the medical device manufacturer shall be given a warning, ordered to make corrections within a time limit and imposed a fine of not more than 30000 yuan:


(1) In violation of the provisions of Article 15 of these measures, failing to notify the decision of recalling the medical device to the medical device business enterprise, user or user within the specified time;


(2) In violation of the provisions of Article 18, paragraph 2 of Article 23 and paragraph 2 of Article 27 of these measures, failing to take corrective measures or recall medical devices as required by the drug regulatory department;


(3) In violation of the provisions of Article 21 of these measures, failing to make detailed records on the handling of recalled medical devices or failing to report to the drug regulatory department.


Article 32 in case of any of the following circumstances, the medical device manufacturer shall be given a warning and ordered to make corrections within a time limit; if it fails to make corrections within the time limit, it shall be fined not more than 30000 yuan:


(1) Failing to establish a recall system for medical devices in accordance with the provisions of these measures;


(2) Refusing to assist the drug regulatory department in the investigation;


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


(4) Where the recall plan is changed but not reported to the drug regulatory department for the record.

Article 33 Where any medical device business enterprise or user violates the provisions of the first paragraph of Article 7 of these measures, it shall be ordered to stop selling and using the defective medical device and be fined not less than 1000 yuan but not more than 30000 yuan; if serious consequences are caused, the original license issuing department shall revoke the medical device business enterprise license.


Article 34 If a medical device business enterprise or user refuses to cooperate with the investigation of the defects of the medical device or to assist the medical device manufacturer in recalling the medical device, it shall be given a warning and ordered to make corrections; if it refuses to make corrections, it shall be fined not more than 30000 yuan.


Article 35 Where the drug regulatory department and its staff fail to perform their duties or abuse their powers, they shall be dealt with in accordance with the relevant laws and regulations.




Chapter VI supplementary provisions


Article 36 If the recalled medical devices have been implanted into the human body, the medical device manufacturer shall consult with the medical institution and the patients together, and propose the treatment opinions and the plan measures to be taken for the patients according to the different reasons of the recall.


Article 37 If the recalled medical devices cause damage to the patients, the patients may claim compensation from the production enterprise, or from the medical device operation enterprise or the user. If a patient claims compensation from a medical device business enterprise or user, the medical device business enterprise or user shall have the right to claim compensation from the responsible manufacturer after making compensation.


Article 38 These Measures shall come into force as of July 1, 2011.

 


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