1 Measures for Administration of Medical Device Recall  
 
Chapter I  General Provisions  
Article 1  In order to strengthen the supervision and management of medical devices and 
protect human health and safety, these Measures are formulated in accordance with the 
Regulation on the Supervision and Administration of Medical Devices  and the Special Rules of 
the State Council on Strengthening the Supervision and Management of the Safety of Food and 
Other Products .  
Article 2  These Measures shall apply to the recall of medical devices sold in the territory 
of the People's Republic of China as well as the supervision and management thereof.  
Article 3  The expression ‘medical device recall’, within the context of these Measures, 
means a medical device manufacturer’s action  of giving a warning about, examining, repairing, 
re-labelling , revising or improving the specifications of, upgrading software for, replacing, 
recalling or destroying a certain category, type or batch of sold defective products in 
accordance with the proc edures provided to eliminate the defect.  
Article 4  The term ‘defect’, within the context of these Measures, means any 
unreasonable risk caused by a medical device in normal use that may endanger human health or 
safety.  
Article 5  A medical device manufact urer is the subject that shall control and eliminate a 
product defect and be responsible for the safety of a product manufactured thereby.  
Article 6  A medical device manufacturer shall establish and improve its medical device 
recall system, collect inform ation about the safety of medical devices, investigate and evaluate 
the potential defective medical devices, and issue a timely recall on the defective medical 
devices in accordance with the provisions of these Measures.  
A medical device trading company o r a unit using the device shall assist the medical 
device manufacturer in fulfilling the obligations of recall, shall communicate and provide 
feedback on t he medical device recall in a timely manner in accordance with the requirements 
of the recall plan, a nd controlling and recovering the defective medical devices.  
Article 7  Should a medical device trading company or a unit using the device find any 
defect in the medical device that it trades or uses, it shall immediately suspend the sale or use 
of the sai d device, promptly notify the manufacturer or supplier, and report it to the drug 
regulatory authority of the province, autonomous region or municipality directly under the  2 central government where the trading company or unit using the device is headquarte red. If the 
unit using the device is a medical institution, the case shall also be reported to the health 
administration authority of the province, autonomous region, or municipality directly under the 
central government where  the unit is headquartered .  
Upon receipt of such a report, the drug regulatory authority of the province, autonomous 
region or municipality directly under the central government where the medical device trading 
company or unit using the device is headquartered shall timely notify its counterpart in the 
province, autonomous region or municipality directly under the central government where the 
manufacturer is  headquartered .  
Article 8  The drug regulatory authority of the province, autonomous region or 
municipality directly under the cen tral government where the manufacturer recalling medical 
devices or the designated agent of an overseas manufacturer of imported medical devices in the 
territory of China is headquartered shall be responsible for the supervision and management of 
medical d evice recalls, while its counterparts in other provinces, autonomous regions or 
municipalities directly under the central government shall provide cooperation and assistance 
for the recalls of medical devices in the jurisdiction thereof.  
The State Food an d Drug Administration shall oversee the management of medical device 
recall s nationwide.  
Article 9  The State Food and Drug Administration and the drug regulatory authority of 
the province, autonomous region or municipality directly under the central gover nment  shall 
establish a medical device recall information communicati on and disclos ure system to 
communicate the relevant information to the health administrative authorities of the same level 
in a timely manner, and take effective measures to disclose the  information about defective 
medical devices and their recalls to the public.  
 
Chapter II  Investigation into and Evaluation of Medical Device Defects  
Article 10  A medical device manufacturer shall establish and improve its medical device 
quality manageme nt system and its medical device adverse event monitoring system, collect 
and record the quality problems of , and the adverse events relating to , medical devices, analyze 
the information collected, and investigate into the possible defects of medical devic es.  
A medical device trading company or unit using the device shall work with the 
manufacturer in carrying out investigation s into defects of the devices, and provide relevant 
information.   3 Article 11  The medical device manufacturer shall be required to t imely submit the 
collected information on adverse events of the medical device to the drug regulatory authorities, 
which may analyze or investigate into the said information or the possible defects, while the 
medical device manufacturer, trading companies and units  using the device shall provide 
assistance for the investigation.  
Article 12  Evaluation of the defects of a medical device shall include the following:  
(1) whether any fault or damage occurs during the use of the medical device;  
(2) whether the device will cause any injury when used under the current circumstances, 
and whether there is any scientific literature, study, relevant test or verification that explains the 
causes of injury;  
(3) territorial scope and population characteristics of the injury;  
(4) the extent of the damage to human health;  
(5) probability of injury;  
(6) short - and long -term consequences of the injury;  
(7) other factors that may cause injuries.  
Article 13  According to the severity of medical device defects, recalls are divided into:  
(1) Class I Recal l: The use of the medical device is very likely to cause a severe health 
hazard;  
(2) Class II Recall: The use of the medical device could  possibl y cause a temporary or 
irreversible  health hazard ;  
(3) Class III Recall: The use of the medical device is not very li kely to cause adverse 
health consequences, but it is still necessary to recall the device.  
The medical device manufacturer shall design and implement a n appropriate  recall plan 
based on the recall classification and the sale and use of the medical device.   
 
Chapter III  Voluntary Recall  
Article 14  If, after the investigation and evaluation as per Articles 10 and 12 has been 
concluded, it is ascertained that the medical device is defective , the manufacturer shall 
immediately decide to recall it.   4 In case of extraterritorial recall, the overseas manufacturer of medical devices shall request 
its designated agent in China to timely report it to the State Food and Drug Administration . In 
the case of recall in the territory of China, its designated agent in China shall be responsible for 
the specific implementation of recall in accordance with these Measures.  
Article 15  Once deciding to recall any medical device, the manufacturer shall notify the 
relevant trading companies, units  using the device or users within o ne (1) day in the case of a 
Class I recall, or three (3) days in the case of a Class II recall, or seven (7) days in the case of a 
Class III recall.  
The recall notice shall at least cover the following:  
(1) Basic information such as the name and batch of the  medical device;  
(2) The reasons for the recall;  
(3) The requirements for the recall: in case of an immediate suspension of the sale and 
use of the product, a recall notice shall be forwarded to the relevant trading companies or units  
using the device ;  
(4) The disp osal of the medical device recalled.  
Article 16  Once deciding to recall any medical device, the manufacturer shall immediately 
inform , in writing , the drug regulatory authority of the province, autonomous region or 
municipality directly under the central government where it is  headquartered , and complete the 
Report of Medical Device Recall Event  (Annex 1) within five (5) days, and at the same time 
submit the investigation and evaluation report and the recall plan to the same authority to be 
put on record .  
The drug regulatory authority of the province, autonomous region or municipality directly 
under the central government shall timely submit the information about Class I Recall to the 
State Food and Drug Administration.  
Article 17  The investigation and ev aluation report  shall include the following:  
(1) The details of the medical device recalled , including basic information such as the 
name and batch thereof;  
(2) The reasons for the recall;  
(3) Results of the investigation and evaluation;  
(4) Classification of the reca ll.   5 The recall plan shall include the following:  
(1) The production and sales of the medical device and the quantity to be recalled;  
(2) The specific recall measures, including the implementation organization, scope and 
time limits;  
(3) Recall information disclosi ng channel and scope;  
(4) The expected effects of the recall;  
(5) The disposal of the medical device recalled.  
Article 18  The drug regulatory authority may organize experts when appropriate to assess 
the recall plan submitted by the manufacturer, and request th e manufacturer to take more 
effective measures such as increasing the recall class, expanding the recall scope, shortening the 
recall time or changing the disposal of products recalled , in case the measures taken are deemed 
to be unable to eliminate the de fects of the medical device.  
Article 19  In case of changing the recall plan, the medical device manufacturer shall 
timely report the change to the drug regulatory authority to be put on record.  
Article 20  During the implementation of the recall, the manu facturer shall regularly 
submit the Report on Implementation of the Recall plan (Annex 2) to the drug regulatory 
authority according to the recall plan, and report the implementation of the recall plan.  
Article 21  The medical device manufacturer shall kee p detailed records of the disposal of 
medical devices, and report to the drug regulatory authority of the province, autonomous region 
or municipality directly under the central government where it is  headquartered . In the case of 
product defects that can b e eliminated by giving a warning about, examining, repairing, 
re-labelling , revising the specifications of, upgrading software for, replacing, recalling or 
destroying defective products, the above can be completed on location . If destruction is 
necessary , the defective product should be destroyed under the supervision of the drug 
regulatory authority at the location where the destr uction will take  place.  
Article 22  After the recall is completed, the manufacturer shall evaluate the effect of the 
recall, and  submit the Summary Report of Medical Device Recall  to the drug regulatory 
authority within ten (10) days of the completion.  
Article 23  The drug regulatory authority shall review the report and evaluate the effect of 
the recall within ten (10) days of the  receipt of the summary report. The review and evaluation 
conclusions shall be presented in writing to the medical device manufacturer , with a copy sent 
to the competent health administrative authority .  6 If the review and evaluation find that the recall is not done thoroughly, and fails to 
effectively remove all the defects, the drug regulatory authority shall require the manufacturer 
to re-recall.  
 
Chapter IV  Compulsory Recall  
Article 24  Where the investigation and evaluation find s any defect mentioned in  Article 4 , 
and where the medical device manufacturer should have voluntarily recalled the product but 
failed to do so, the manufacturer shall be ordered to recall the said device.  
When necessary, the drug regulatory authority shall require the medical de vice 
manufacturer, trading companies or units  using the device to immediately suspend the sale or 
use of, and inform the users to immediately suspend the use of, the medical device.  
Article 25  Once deciding to order a recall, the drug regulatory authority  shall serve a 
compulsory recall notice to the medical device manufacturer or the domestic agent of 
manufacturer of imported medical devices, and the notice shall include the following:  
(1) The details of the medical device recalled , including basic informati on such as the 
name and batch thereof;  
(2) The reasons for the recall;  
(3) Results of the investigation and evaluation;  
(4) The requirements for the recall , including the scope and time limits.  
Article 26  Upon the receipt of the compulsory recall notice, the manuf acturer shall request 
the medical device trading companies, units  using the device or users to develop and submit the 
recall plan, and organize the implementation thereof in accordance with the provisions of 
Articles 15 and 16 hereof.  
Article 27  The manuf acturer shall report the relevant circumstances of the medical device 
recall to the drug regulatory authority, and carry out the follow -up disposal of the devices in 
accordance with the provisions of Articles 19, 20, 21 and 22 hereof.   
The drug regulatory  authority shall review the Summary Report of Medical Device Recall  
submitted by the manufacturer, and evaluate the effects of the recall, and timely inform the 
competent health administrative authority. If the review and evaluation find that the recall has 
not been done thoroughly, and has failed to effectively remove all the defects, the drug 
regulatory authority shall require the manufacturer to re -recall.   7  
Chapter V  Legal Liability  
Article 28  Where the drug regulatory authority confirms that the defect s of medical 
devices on the market are caused by the manufacturer in violation of laws, regulations and 
rules, administrative penalties shall be imposed on the manufacturer . If the manufacturer has 
voluntarily taken recall measures to eliminate or alleviat e the consequences, a lighter or 
mitigated penalty shall be imposed on them in accordance with the Administrative Penalty Law . 
Where the offense is minor and is promptly corrected without any harmful consequence s, the 
manufacturer may be exempt  from punish ment.   
A medical device manufacturer’s act of recall does not exempt it from other legal 
liabilit ies.  
Article 29  Where a medical device manufacturer violates the provisions of these Measures 
by failing to voluntarily recall the known defective medical dev ices, the manufacturer shall be 
ordered to recall the devices, and a penalty three times the value of the medical devices that 
should have been recalled shall be imposed on t hem. I n case s where serious consequences  have 
been caused, the original license is suing authority shall revoke the medical device registration 
certificate, or even the License for Medical Device Manufacturer .  
Article 30  Where a medical device manufacturer violates the provisions of Article 24 by 
refusing to recall the medical devices, a penalty three times the value of the medical devices 
that should have been recalled shall be imposed on t hem. I n case s where serious consequences 
have been caused, the original license issuing authority shall revoke the medical device 
registration certif icate, or even the License for Medical Device Manufacturer .  
Article 31  Where a medical device manufacturer violates the provisions of Article 15 by 
failing to request the trading companies, the units  using the device , or the users to suspend the 
sale or u se of the medical devices to be recalled, t he manufacturer  shall be given a warning and 
be charged to make corrections, and a penalty less than RMB30,000 shall be imposed on t hem.  
Article 32  Where a medical device manufacturer violates the provisions of A rticles 18, 
23(2) and 27(2) by failing to take corrective measures or to re -recall the medical devices as 
required by the drug regulatory authority , the manufacturer  shall be given a warning and be 
charged to make corrections, and a penalty less than RMB30 ,000 shall be imposed on t hem.  
Article 33  Where a medical device manufacturer violates the provisions of Article 21, the 
manufacturer  shall be given a warning and be charged to make corrections, and a penalty less 
than RMB30,000 shall be imposed on t hem.   8 Article 34  The medical device manufacturer shall be given a warning and be charged to 
make corrections, and a penalty less than RMB20,000 shall be imposed on them, in one of the 
following circumstances:   
(1) failing to establish the medical device recall syst em;  
(2) refusing to assist the drug regulatory authority  in making investigations;  
(3) failing to submit the  Report of Medical Device Recall Event , the investigation and 
evaluation  report and the recall plan, the medical device recall progress report or the summ ary 
report , in accordance with the provisions of these Measures;  
(4) failing to file the change to the recall plan with the drug regulatory authority  for their 
records.  
Article 35  Where a medical device trading company or a units  using the device violates 
the provision of Article 7(1) of these Measures, the company or unit shall be ordered to stop 
selling or using the defective medical devices, and a penalty of RMB1,000 -50,000 shall be 
imposed on t hem. I n case s where there are serious consequences, the origin al license issuing 
authority shall revoke the License for Medical Device Trading Company .  
Article 36  Where a medical device trading company or unit using the device refuses to 
work with the manufacturer or the drug regulatory authority to conduct an inves tigation into 
the defects of the medical device, or refuses to assist the manufacturer in recalling the defective 
medical devices, the company or unit shall be given a warning and ordered to make corrections. 
In case s where there is a refusal to make corre ctions, a penalty less than RMB20,000 shall be 
imposed on t hem.  
Article 37  In cases w here the drug regulatory authority and its staff fail to perform their 
duties or abuse their authority, the case shall be addressed in accordance with relevant laws and 
regulations.  
 
Chapter VI  Supplementary Provisions  
Article 38  In cases where t he medical device manufacturer, trading company or unit using 
the device violates these Measures and causes damages to the users of the medical device, it 
shall be liable for comp ensation  according to the law .  
Article 39  These Measures shall go into effect  as of [date].   9 Annex 1:  
Report of Medical Device Recall Event  
Name of the Product   Registration 
Certificate No.   
Manufacturer   
Responsible Unit or 
Person and their 
Contacts in China   
Contacts for Recall   
Scope of Application of 
the Product   
Country/Region 
Involved   Model and 
Specifications of the 
Product Involved   
Quantity of the 
Manufactured (or 
Imported) Products 
Involved   Sales of the Product 
Involved in China   
Identification  
(e.g. Batch No.)   
 
Outline of Reasons for 
Recall   
 
Outline of Corrective 
Actions   
 
Reporting Unit: (Seal)  Responsible Person: (Signature)  
Reported by: (Signature)  Date:   10 Annex 2:  
Report on the Implementation of the Recall Plan  
Name of the P roduct   Registration Certificate No.   
Manufacturer   
Agent in China and 
Responsible Person 
and their Contacts   
Contacts for Recall   
Number of People to Be 
Notified   
Number of People Not ified  
Time of Notice   Receiver Responsible 
for Communication 
for Recall  
Means of Notifying   
Number of People to Be 
Notified   
Number of People Notified   
Time of Notice   Notification  
Other Receivers  
Means of Notifying   
Quantity of Products 
to Be Recalled   
Quantity of Products 
Recalled   Completion  
Effective Inspection   
Disposal of Recalled Products   
Estimated Time for Completing the 
Recall    11 Miscellaneous   
 
 
 
 
 
 
 
 
 
 
 
 
 
Reporting Unit: (Seal)  Responsible Person: (Signature)  
Reported by: (Signature)  Date: