Chapter 1 General Principles

The first is to strengthen the supervision and management of medical equipment，Control medical equipment products with defects，Eliminate the hidden dangers of medical equipment，Make sure the safety of medical equipment、Effective，Guarantee human health and life safety，According to the "Regulations on the Supervision and Administration of Medical Devices"，Formulate these measures。

2 The recall and supervision and management of medical devices on the People's Republic of China，Applicable these Measures。

Article 3 The recall of medical device referred to in these Measures，refers to a category of medical device manufacturers in accordance with the prescribed procedures、Model or batches of defective medical equipment products，Take a warning、Check、Repair、Re -label、Modify and improve the instructions、Software update、Replace、Recovery、Destroyer and other methods to deal with treatment。
The medical device production enterprise described in the preceding paragraph，refers to the registrar or recorder of the domestic medical device product、Overseas manufacturers of imported medical equipment。

Article 4 Medical device products that are described in these Measures include:
(1) Unreasonable risks that may endanger human health and life safety under normal use;
(2) Do not meet the compulsory standard、Product technical requirements for registered or filed products;
(3) Do not meet the production of medical equipment、Business quality management regulations leading to unreasonable risks;
(4) Other products that need to be recalled.

Fifth medical device manufacturer is the responsible subject to control and eliminate product defects，It should take the initiative to recall the defective products。

6 -medical device production enterprise shall establish and improve the management system of medical device recall in accordance with the provisions of these Measures，Collect information on medical device safety related information，Investigate possible defective products、Evaluation，Timely recall defective products。
Overseas manufacturers of imported medical devices in China shall report relevant information about the National Food and Drug Administration in time to implement the relevant information of the recall of medical device in China;，The designated agents designated in China shall organize implementation in accordance with the provisions of these Measures。
Medical Devices Business Enterprise、Use unit shall actively assist medical device manufacturers to investigate defective products、Evaluation，Actively cooperate with the production enterprise to perform the recall obligation，Discard it in time according to the recall plan、Feedback medical device recall information，Control and recover defective products。

Seventh medical device business enterprise、Use unit to find its business、Medical devices used may be the defective product，It should be suspended immediately or using the medical equipment，Timely notify medical device manufacturers or suppliers，and province in your place、Autonomous Region、The food and drug supervision and management My stake betting appdepartment of the municipality directly under the Central Government; the use unit is a medical institution，It should also be provinced to the local area、Autonomous Region、Report on the health administrative department of municipality directly under the Central Government。
Medical Devices Business Enterprise、The province where the unit is located、Autonomous Region、The food and drug supervision and management My stake betting appdepartment of the municipality directly under the Central Government received the report，It should be notified in a timely manner in the province where the medical device manufacturer is located、Autonomous Region、Food and Drug Supervision and Management Department of Municipality directly under the Central Government。

Article 8 The province of the manufacturer of the recalled medical device、Autonomous Region、The food and drug supervision and management My stake betting appdepartment of the municipality directly under the Central Government is responsible for the supervision and management of medical device recall，Other provinces、Autonomous Region、The food and drug supervision and management department of the municipality directly under the Central Government shall cooperate with the work of recalling the recall of medical device in this administrative area。
The State Food and Drug Administration supervised the management of the recall of national medical equipment。

9 The State Food and Drug Administration and province、Autonomous Region、The food and drug supervision and management My stake betting appdepartment of the municipality directly under the Central Government shall be in accordance with the medical equipment recall information notification and information disclosure system，Adopt effective ways to publish to the society to publish defective product information and recall information，Relevant information to the health administrative department of the same level if necessary。

Chapter 2 Investigation and Evaluation of Medical Device Defects

Article 10 Medical Device Manufacturers shall establish and improve the quality management system and medical device adverse event monitoring system in accordance with regulations，Collection、Record the quality complaint information of medical device and adverse event information for medical equipment，Analysis of the collected information，Investigate and evaluate the possible defects。
Medical Devices Business Enterprise、Use unit shall cooperate with medical device manufacturers to investigate the defects of relevant medical equipment，Provide relevant information。

Article 11 Medical device manufacturers shall report the collected medical device adverse events in accordance with regulations，The food and drug supervision and management department can analyze and investigate the adverse incidents or possible defects of medical equipment，Medical Devices Production Enterprise、Business Enterprise、Use unit shall cooperate。

Article 12 The main content of evaluating the defective medical equipment products includes:
(1) Whether the product meets the compulsory standard、Registered or filed product technical requirements;
(2) Whether a fault or damage occurred during the use of medical equipment;
(3) Whether it will cause damage in the existing use environment，Is there any scientific literature、Research、Related tests or verification can explain the cause of damage;
(4) The area and crowd characteristics involved in the damage;
(5) The degree of damage to human health;
(6) The probability of damage occur;
(7) The short -term and long -term consequences of damage;
(8) Other factors that may cause damage to the human body.

Article 13 According to the severity of the defects of medical equipment，Medical equipment recall is divided into:
(1) First -level recall: The use of this medical equipment may or has caused serious health hazards;
(2) Class 2 recall: The use of this medical device may or has caused temporary or reversible health hazards;
(3) Level 3 recall: The possibility of using this medical device to cause harm is less likely but still requires recall。
Medical device manufacturers shall determine the recall level according to the specific situation and the sales and use of medical device，Scientific design recall plan and organize implementation。

Chapter 3 Active Recall

Article 14 Medical Device Production Enterprise according to Article 10 of these Measures、The requirements of Article 12 are investigated and evaluated，Determine the defects of medical equipment products，shall immediately decide and implement the recall，Publish product recall information to the society at the same time。
Implementing first -level recall，The announcement of the recall of medical equipment shall be released on the website of the State Food and Drug Administration and the main media of the central government;、Three -level recall，The announcement of the recall of medical device should be in the province、Autonomous Region、Published by the website of the Food and Drug Supervision and Management My stake betting appdepartment of the municipality directly under the Central Government，Provincial、Autonomous Region、The recall announcement issued by the website of the Food and Drug Supervision and Administration of the Municipality directly under the Central Government shall link with the website of the State Food and Drug Administration。

Article 15 The medical device manufacturer makes a medical device recall decision，The first -level recall should be within 1 day，The second -level recall should be within 3 days，Third -level recall should be within 7 days，Notification to the relevant medical device business enterprise、Use unit or inform users。
Recall notification shall include the following:
(1) Name of recall medical equipment、Model specification、Batch and other basic information;
(2) Reasons for recall;
(3) Requirements for recall，If you immediately suspend sales and use this product、Repost the recall notification to related business enterprises or use units, etc.;
(4) The treatment method of recall medical equipment.

Article 16 Medical Device Manufacturing Enterprise Makes a Medical Equipment Recall Decision，It should be immediately provinced to the location of the Stake Sports Bettinglocation、Autonomous Region、Food and Drug Supervision and Administration Department of Municipality and the Food and Drug Supervision and Administration Department approved the registered food and drug supervision and management department of the product to submit the medical device recall report form，and submit the survey and evaluation report and recall plan within 5 working days to the province where it is located、Autonomous Region、Food and Drug Supervision and Administration Department of Municipality and the Food and Drug Supervision and Administration Department for the Food and Drug Supervision and Management Department of the Food and Drug Supervision and Management Department of the Food and Drug Supervision and Management Department。
The province of the medical device manufacturer is located、Autonomous Region、The food and drug supervision and management department of municipality directly under the Central Government shall report the relevant situation of the recall of the recall of the recall of the recall report of the recall report.。

Article 17 The survey and evaluation report shall include the following content:
(1) The specific situation of recall medical equipment，Including names、Model specification、Batch and other basic information;
(2) The reasons for the recall;
(3) The results of the survey and evaluation;
(4) Recall hierarchy.
The recall plan shall include the following:
(1) The production and sales of medical device and the number of recovery;
(2) The specific content of the recall measures，Including the implementation of the organization、range and time limit, etc.;
(3) Announcement and scope of recall information;
(4) The expected effect of the recall;
(5) treatment measures after the recall of medical equipment.

Article 18 of the province of medical device manufacturers、Autonomous Region、The food and drug supervision and management department of municipality may evaluate the recall plan submitted by the manufacturer，It is believed that the measures taken by the manufacturer cannot effectively eliminate product defects or control product risks，It should be written in writing to improve the recall level、Expand the range of recall、Short the recall time or change the processing method of recall products to handle more effective measures for treatment。Medical device manufacturers shall modify the recall plan and organize implementation in accordance with the requirements of the food and drug supervision and management department。

Article 19 Medical Device Manufacturers to change the reported recall plan，It should be reported in time in time、Autonomous Region、Food and Drug Supervision and Administration of Food and Drugs directly under the Central Government。

Article 20 During the recall of medical device manufacturers，It should be regularly to the local province in accordance with the recall plan、Autonomous Region、The food and drug supervision and management My stake betting appdepartment of the municipality directly under the Central Government submits a report on the implementation of the recall plan。

Twenty -one medical device manufacturers shall have a detailed record of the treatment of recalled medical devices，And the location of the medical device manufacturer、Autonomous Region、Report on the food and drug supervision and management department of municipality directly under the Central Government，Records should be stored until 5 years after the medical device registration certificate fails，The processing record of the recall of the first type of medical device should be stored for 5 years。Through warning、Check、Repair、Re -label、Modify and improve the instructions、Software update、Replace、Destruction and other methods can eliminate product defects，You can complete the above behavior at the location of the product。It needs to be destroyed，Destruction should。

Article 22 The medical device manufacturer shall evaluate the recall effect within 10 working days after the recall is completed，and province in your place、Autonomous Region、The food and drug supervision and management My stake betting appdepartment of the municipality directly under the Central Government submits a medical device recall summary assessment report。

Article 23)、Autonomous Region、The food and drug supervision and management My stake betting appdepartment of the municipality directly under the Central Government shall review the report within 10 working days from the date of receiving the summary evaluation report，and evaluate the recall effect; believe that the recall has not effectively eliminated product defects or controlling product risks，It should be required to recall the manufacturer in writing。Medical device manufacturers shall re -recall the requirements of the food and drug supervision and management department。

Chapter 4 Order to recall

Article 24 The food and drug supervision and management department is investigated and evaluated，It is believed that medical device manufacturers should recall the defective medical device products without actively recalling，Should be ordered to recall medical equipment for medical device manufacturers。
The decision to order the recalled can be ordered by the medical device manufacturer.、Autonomous Region、Food and drug supervision and management department of municipality directly under the Central Government，It can also be made by the food and drug supervision and management department approved by the medical device to register or the filing of the filing。Make the food and drug supervision and management department of this decision，It should be ordered to order recall information to the society on its website。
Medical device manufacturers shall recall in accordance with the requirements of the food and drug supervision and management department，and publish product recall information to the society in accordance with Article 14 (22 of these Measures。
When necessary，Food and Drug Supervision and Administration Department may require medical device production enterprises、Operating enterprises and use units immediately suspend production、Sales and use，and inform the user to suspend the use of this defect product immediately。

Article 25 of the Food and Drug Supervision and Administration Department to order the removal decision，It shall order the recall notice to the medical device manufacturer，Notice includes the following:
(1) The specific situation of recall medical equipment，Including names、Model specification、Batch and other basic information;
(2) The reasons for the recall;
(3) The results of the survey and evaluation;
(4) Recall requirements, including scope and time limit.

Article 26 After receiving an order of the recall notice, a medical device manufacturer，It should be in accordance with Article 15 of these Measures、Article 16 The provisions are notified of medical device business enterprises and use units or users，Formulate、Submit the recall plan，Article 21。

Twest of medical device manufacturers shall be in accordance with Article 19 of these Measures、Article 20、Article 21、Article 22 provides to report to the recall of medical device recall to the food and drug supervision and management department，Follow -up treatment of recall medical devices。
Food and Drug Supervision and Administration shall review the medical device recall summary assessment report for medical device manufacturers in accordance with Article 23 of these Measures，and evaluate the recall effect，Report the health administrative department of the same level if necessary。After review and evaluation，Think that the recall is not thorough、It has not effectively eliminated product defects or controls product risk，Food and Drug Supervision and Administration should request medical device manufacturers to recall。Medical device manufacturers shall re -recall the requirements of the food and drug supervision and management department。

Chapter 5 Legal Responsibility

Article 28 of the medical device manufacturer due to violation of the law、Regulations、Regulations stipulate that there are defects in the market medical equipment，Administrative penalties should be given in accordance with the law，But the company has taken recall measures to actively eliminate or reduce the consequences of harm，Food and Drug Supervision and Administration Department shall be given a light or reduced punishment in accordance with the provisions of the People's Republic of China;，No harmful consequences，No punishment。
Medical Device Manufacturing Enterprise Recall Medical Device，It will not be available to other legal liabilities that should be assumed in accordance with the law。

Article 29 Medical Device Manufacturers violate Article 24 of these Measures，Refusing to recall medical equipment，Processing in accordance with Article 66 of the Regulations on the Supervision and Administration of Medical Devices。

Article 30 Medical Device Production Enterprise has one of the following situations，Warning，Order to correct the time limit，Paimated a fine of less than 30,000 yuan:
(1) Violation of Article 14 of these Measures，Those who have not published product recall information to the society in a timely manner;
(2) Violation of Article 15 of these Measures，The decision to recall the recalled medical equipment within the specified time is notified to the medical device business enterprise、Use unit or inform users;
(3) Violation of Article 18 of these Measures、Article 23、Article 27, paragraph 2 provisions，Failure to take correction measures or recall medical devices in accordance with the requirements of the food and drug supervision and management department;
(4) Violation of Article 21 of these Measures，Detailed record of the treatment of recalled medical devices or not reporting to the food and drug supervision department。

Article 31 of the medical device manufacturer has one of the following situations，Warning，Order to make corrections within a time limit;，Fined fines below 30,000 yuan:
(1) Those who have not established a medical device recall management system in accordance with these Measures;
(2) Refusing to cooperate with the food and drug supervision and management department to conduct investigations;
(3) The report of the recall of medical device recall is not submitted in accordance with these Measures、Investigation and evaluation report and recall plan、The implementation of the medical device recall plan and the summary evaluation report;
(4) Change the recall plan，Not reported to the food and drug supervision and management department for filed。

Article 32 of the medical device business enterprise、Use unit violations of Article 7 of these Measures，Order to stop sales、Use the defective medical equipment，Put a fine of 5,000 yuan and less than 30,000 yuan;，The "Medical Devices Business License" was revoked by the original certificate department。

Article 33 of the medical device business enterprise、Use unit refuses to cooperate with the relevant medical equipment defect survey、Refusing to assist medical device manufacturers to recall medical equipment，Warning，Order to make corrections within a time limit;，penalties below 30,000 yuan。

Article 34 The food and drug supervision and management department and their staff do not perform the responsibilities of medical device supervision and management or abuse of authority、Ignoring the duty，There is one of the following situations，by the supervisory organs or appointment and removal agencies according to the weight of the plot，Criticism and education to the person in charge and other directly responsible persons，or give warnings in accordance with the law、Remember or remembers the sanction; cause serious consequences，Give a downgrade、Remove or fired punishment:
(1) If the recall information is not posted to the society in accordance with regulations;
(2) Those who fail to report or report relevant recall information to the relevant departments in accordance with regulations;
(3) It shall be ordered to be recalled without ordering recall measures;
(4) Violation of Article 23 and Article 27 of these stake betting appMeasures，Failure to urge medical device manufacturers to effectively implement the recall。

Chapter 6 Attachment

Article 35 of the medical device recall has been implanted in the human body，Medical device manufacturers shall negotiate with medical institutions and patients，According to the different reasons for recall，Put forward the handling opinions on patients and the plan that should be taken。

Article 36 The recalled medical device to cause damage to patients，Patients can request compensation from medical device manufacturers，You can also operate with medical device、Use unit request compensation。Patients with medical device business enterprises、The required compensation required by the unit，Medical Device Business Enterprise、After the use of the unit compensation，Requirements to the responsible medical device manufacturers。

Article 37 This Measures will be implemented from May 1, 2017。"Management Measures for Medical Device Recall (Trial)" (trial) implemented from July 1, 2011 (Trial) (Health of the People's Republic of China No. 82)。