Supervision and Management for the recall of strengthening medical equipment，Effectively promote the implementation of the responsibility of the company's recall of the main body，According to the "Regulations on the Supervision and Administration of Medical Device" (hereinafter referred to as the "Regulations")，The State Food and Drug Administration has formulated and promulgated the "Measures for the Administration of Medical Device Recall" (hereinafter referred to as the "Measures"。The Measures will be implemented on May 1, 2017，The relevant content is interpreted as follows:

I. Why is the Measures modified?

Medical equipment as a special product，In improving people's health level、Improve people's quality of life，Play an important irreplaceable role。Safety and effectiveness of medical equipment，It is directly related to the health and social harmony and stability of the people of the people，It is a major problem of people's livelihood and public safety。The product after listing is defective and cannot be recalled and controlled in time，It is possible to endanger consumers' health and safety。So，The state established and implemented a recall system for medical device products，Risk of medical device products with defects after controlling the listing，Eliminate the hidden dangers of equipment safety，Protecting public security has an important role。Practice in other countries and other fields also indicates，The recall system is a powerful guarantee for maintaining consumer safety and rights and interests。This importance based on the recall system of medical equipment，In order to strengthen the supervision and management of recalling related work，2011，The Ministry of Health of the People's Republic of China released the "Measures for the Management of Medical Device Recall (Trial)" (Order No. 82) (hereinafter referred to as "Measures (Trial)"，From July 1, 2011。"Measures (Trial)" version of the release and execution，In order to control the risk of medical device after the listing in time，Protecting public weapon safety provides legal guarantee。Implementation stake sports betting appof the recall system for medical device，Not only the risk of controlling medical equipment、Promoting production technology progress、Effective method of perfect product design，It is also promoting production enterprises to improve product quality awareness，Important measures to standardize market competition order。
The newly revised Regulations in 2014 include the recall system into it，It has also become a highlight of the new version of the Regulations。In order to further strengthen the management of medical equipment recall，According to the requirements of the Regulations，Based on the full investigation of the recall system at home and abroad，Combined with my country's national conditions and practice，Consultation of all parties，Repeated discussion and modification of the "Measures (Trial)" version，Amendment completes this "Measures"。

2. What are the main contents of the Measures?

(1) What is the definition of medical device recall?
"Measures" referred to medical device recall，refers to a certain category of medical device manufacturers in accordance with the prescribed procedures、Model or batch of defective medical equipment products，Take a warning、Check、Repair、Re -label、Modify and improve the manual、Software update、Replace、Recovery、Destruction and other methods of treatment。

(2) What is the recall obligation of medical device manufacturers?
Medical Device Manufacturers are the responsible subject of the quality and safety of the production of medical equipment。The management system should be established and improved in accordance with the provisions of the Measures，Collection of medical device safety related information，Investigate possible defective products、Evaluation，Timely recall defective products。
The overseas manufacturers of imported medical devices in China shall report relevant information about the State Food and Drug Administration in time to implement relevant information of the recall of medical equipment overseas;，The agent designated in China shall organize implementation in accordance with the provisions of the Measures。

(3) Medical Device Business Enterprise、What is the recall obligation to use the unit?
Medical Device Business Enterprise、The 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。

(4) How many categories of medical device callbacks?
Different startups of the recall of medical equipment，Medical equipment recall is divided into active recall and order recall。
Active recall is a quality assessment of medical device products for medical device manufacturers in accordance with relevant requirements or information such as product adverse stake betting appevents，Determine the defects of medical equipment products，Recall by the active implementation of the manufacturer，Is the legal obligation of the enterprise。Ordering the recall is the food and drug supervision and management department investigated and evaluated，It is believed that medical device manufacturers should recall the defective medical device products without actively recalling，Order the medical device recall of medical device manufacturers。In practice，It should be based on the active recall of the enterprise，Government departments order the recall as a supplement。

(5) What are the recalls of medical devices?
According to the severity of medical equipment defects，Medical equipment recall is divided into:
(1) First -level recall: The use of this medical device may or has caused serious health hazards;
(2) Class 2 recall: The use of this medical device may or has already 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。
Medical device manufacturers make a medical device recall decision，The first -level recall is within 1 day，The second -level recall is within 3 days，Level 3 recall is within 7 days，Notification to the relevant medical device business enterprise、Use unit or inform users。
Recall notification shall include at least the following content:
(1) Name of recall medical equipment、Batch and other basic information;
(2) Reasons for recall;
(3) Requirements for recall，If you suspend sales and use this product immediately、Repost the recall notification to related business enterprises or use units, etc.;
(4) The treatment method of recall medical equipment.

(6) How to punish medical device manufacturers to refuse to recall medical equipment?
Medical device manufacturers violate Article 24 of the Measures，Refusing to recall medical equipment，According to the provisions of Article 66 of the Regulations，The food and drug supervision and management department of the people's government at or above the county level ordered to correct it，Confine illegal production、Medical equipment operating or used; illegal production、The value of the medical device that is operated or used for less than 10,000 yuan，Packed of fines of 20,000 yuan and 50,000 yuan; the value of the value of the value of 10,000 yuan，Posted the amount of the value of more than 5 times the amount of more than 10 times;，Order to suspend production and business，until the medical device registration certificate was revoked by the original certificate department、Production permit for medical device、Medical Device Business License。

(7) Medical Device Business Enterprise、How to punish My stake betting appthe unit's refusal to cooperate with medical device manufacturers to perform the recall responsibility?
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;，fines below 30,000 yuan。

3. What are the modification points of the Measures?

"Measures" includes general rules、Investigation and evaluation of medical device defects、Active recall、Order to recall、Legal liability、Attachment a total of 6 chapters 37 content。Amendment of the Measures，The framework and main content of the "Measures (Trial)" retained，According to the Regulations，Focus on the scope of the recall and individual operating procedures to supplement and adjust，strengthened the main responsibility and legal responsibility of the manufacturer，The punishment for violations of laws and regulations，The main modification content includes:

(1) The responsible subject of the recall of medical equipment。Clarify the registrar or recorder of the domestic medical device product、Overseas manufacturers of imported medical devices in China are designated in China as the main body of medical device recall。

(2) Clarified the scope of application。"Measures (Trial)" stipulate，"This method applies to the recall and supervision and management of medical devices sold in the People's Republic of China"，"Measures" modified to "Recall and supervision and management of medical devices on the People's Republic of China"，Clarified the medical equipment products registered in my country，Recalling in China or overseas，All shall be implemented or reported in accordance with the requirements of this Measures。

(3) Adjust the scope of defective products。"Measures (Trial)" stipulates that "the recall of medical device referred to in these measures，refers to a category of medical device manufacturers in accordance with the prescribed procedures for its laid -up and sales.、Model or Batch Product，Take a warning、Check、Repair、Re -label、Modify and improve the manual、Software upgrade、Replace、Recovery、Destruction and other methods to eliminate defects "，"Deficiency referred to in this Measures，refers to the unreasonable risk of medical devices that may endanger human health and life safety under normal use "，The scope of the recall is a medical device that may endure unreasonable risks that may endanger human health and life safety under normal use。"Measures" according to the newly revised "Regulations"，Expand the scope of defective products into "(1) unreasonable risks that may endanger human health and life safety under normal use; (2) do not meet the mandatory standards、Products registered or filed with products; (3) the production of medical equipment、Cultivation Quality Management Related Regulations leading to unreasonable risks; (4) Other products that need to be recalled "。

(4) Added defect evaluation content。Corresponding to the modification of the scope of the product'stake sports betting apps product，The main content of evaluation of medical equipment defects，Added "whether the product meets the compulsory standard、Product technical requirements for registered or filed ""。

(5) Adjusted the regulatory authorities for supervision and recalling products。"Measures (Trial)" stipulates that "the need to be destroyed，Destruction shall be destroyed under the supervision of the drug supervision and management department of the destruction place "。But in practice，This method is not conducive to actual operation。At the same time，The current information technology is changing with the current，The diversification of the supervision method is the general trend。So，"Measures" modified to "need to be destroyed，Destruction should。” 

(6) Adjusted the requirements for recall information report。"Measures (Trial)" stipulates that "the drug supervision and management department shall review the report within 10 days from the date of receiving the summary report，and evaluate the recall effect。Examination and evaluation conclusions shall notify medical device manufacturers in writing and copy the health administrative department of the same level "。In practice，Examination and evaluation conclusion The written form of notifying medical device manufacturers and notifying the requirements of the health administrative department at the same level is difficult to operate。So，"Measures" cancel the requirements of the manufacturer，The information notification from the health administrative department will be modified to "Relevant information to the health administrative department at the same level when necessary"。