医疗器械召回管理办法—英文版

Ministry of Health of People’s Republic of ChinaOrdinance No.The Regulation of Medical Devices Recall Administration (Test) was approved by the Conference of Ministry of Health on June 28th 2010, and will be activated on July 1st 2010.The Regulation of Medical Devices Recall Administration (Test)Chapter 1General GuidelineArticle 1For better supervision of Medical Devices, to guarantee people’s health and well-being, according to The Administration of Medical Devices, and State Council: About the Special Rules for the improvement of Food and Food Safety, this legislation is drafted.Article 2This regulation applies to Medical Devices sold within PRC.Article 3The definition of Medical Devices recall refers to the actions taken to eliminate the defects of the already sold devices, such as warning, checking, re-labeling, fixing, amending, and completing user’s guides, software updating, replacing, recalling, and destroying of a certain line or model.Article 4The defects mentioned above refers to the medical devices that may be of unreasonable safety or health hazards to people when operated under normal conditions.Article 5The major force of the controlling and eliminating of defective products are the manufacturers of medical devices, therefore these companies are to take full responsibilities for the safety of their products.Article 6Under this regulation, the medical devices’ manufacturers are to establish and perfect their recalling system, to collect the related information regarding the safety of their medical devices, and to investigate, estimate their possible defective products, in order to recall these defective medical devices promptly.Companies that run business with or make use of the medical devices are obliged to assist with the recalling of the medical devices, and informing feedbacks on the recalling information, controlling and reclaiming the defective medical devices strictly according to the recalling regulation.Article 7On condition that companies that run business with or make use of the medical devices discover the medical devices they possess are defective items, the usage and marketing of these products are to stop immediately, while they should inform the manufacturing and supplying parties of these certain products, and report to the Food and Drug Administration and Supervision Department where they belong to; the organizations making use of these devices are also to report to the Health Administration of the province, Autonomous Region or Municipality directly under the Central Government.After receiving the reports from these companies, the Administration Department should notify the Health Administration of the province, Autonomous Region or Municipality directly under the Central Government of the manufacturing company.Article 8For the manufacturers that are having their devices called back, the appointed agencies in China of the imported medical devices manufactured over-seas are under the administration of Health Administration of the province, Autonomous Region or Municipality directly under the Central Government, and they are in charge of the reclamation of these devices, and the other provinces and regions equivalent to it should provide with assistance, cooperate this region with the reclamation and the related work.The SFDA is in charge of the management of recalling of medical devices national-wide.Article 9SFDA and local administration departments should setup an open system for the recalling of medical devices, for the prompt sharing of information among health administrations of the equivalent level, so that effective measures can be taken leading to the publication of the information and reclamation of the defective devices to the society.Chapter 2Investigation and Evaluation of Defective Medical Devices Article 10The manufacturers are to establish and perfect the quality management controlling system, and the supervision system in times of defective incidents, to report, collect the information regarding the quality problems and harmful evens. And investigate and evaluate the possible defects of medical devices.Companies that run business with or make use of the medical devices should cooperate with the manufacturers to investigate and provide necessary documents of the defective products.Article 11The manufacturers should promptly collect and report to the administration departments regarding the defective events, and the administration departments can estimate and investigate the possible defective events, and the companies that run business with or make use of the medical devices should provide assistant.Article 12The evaluation of defective devices mainly includes:1.Whether a malfunction or harm has occurred during usage;2.Whether there will be possible harms when used under current conditions,and whether the causes of such harms can be explained by the scientific papers, researches, or relevant exams;3.The features of the regions and its people involved where the harmsoccurred;4.The degree of harms done to people’s health;5.The occurring ratio of such harms;6.The short and long term results of such harms;7.Other possible factors that could bring harm to people.Article 13According to the seriousness of the defective devices, they are categorized into:1.Level one recall: serious harms to health may or have already occurred usingthis certain medical device;2.Level two recall: reversible harms to health may or have already occurredusing this certain medical device;3.Level three recall: the possibility of harmful events occurring is minimalusing this certain medical device, but still it needs to be called back.The manufacturers need to organize and carry out the recalling system scientifically according to the categories of the seriousness of defects, and the sales and usage of the devices.Chapter 3Active RecallArticle 14According to Article 10, 12, after the investigation and evaluation of the medical devices, and certify that these are defective devices; decisions of recalling should be made immediately.When device-recalling occur overseas, the overseas manufacturers of imported medical devices should notify their appointed Chinese agencies and report to the SFDA promptly; when such actions occur in China, the appointed Chinese agencies should carry out the details according to this regulation.Article 15For the decisions made to recall the medical devices, notices have to be sent to the related companies or individuals that run business with or make use of the medical devices. Level one is within 1 day, level two is within 3 days, and level three is within 7 days.The recalling notice at least contain the following contents:1.The names, batch information of the recalled medical devices;2.The reason for the call back;3.The requirement of the recall: such as to suspend the sales and usage of theseproducts, forward the recall notice to the related operating and using companies;4.The processing measurements of these recalled products.Article 16Decisions upon the recall of the medical devices by the manufacturers should be formally notified to the Food and Drug Administration Department of the province, autonomous region or municipality directly under the Central Government, and a Report of Device recalled incidents should be filled in 5 days. (See Appendix 1), and a report and proposal of investigation and evaluation should be handed in to the Food and Drug Administration of the province, Autonomous Region or Municipality directly under the Central Government for record.Food and Drug Administration of the province, Autonomous Region or Municipality directly under the Central Government should report promptly to the SFDA in case of level one events occurring.Article 17The investigation and evaluation report should include the following information:1.Detailed information of the recalled medical devices, including basicinformation such as their names and batch;2.The reason for the recall;3.The result of the investigation and evaluation;4.Level of recall;5.Measures to be taken for after the recalling of the medical devices.Article 18Food and Drug Administration of the province, Autonomous Region or Municipality directly under the Central Government can have experts evaluate their proposal of the recall according to practical situation. If the proposal is considered ineffective of the elimination of the defects, manufacturers should be ordered to upgrade the recall level, expend the recalling range, shorten recalling time or alter the measures to be taken for more effective ones.Article 19For decisions made by the manufacturers to alter the recalling proposals that are already reported, a back-up record should be proposed promptly to the Food and Drug Administration.Article 20During the recall procedure of the medical devices manufacturers, a Report of the Enforcement of recall schedule should be sent regularly to the Food and Drug Administration. (See Appendix 2) It is to report the actual enforcement of the proposal.Article 21Detailed records should be kept for the handling of recalled medical devices, and to report to the Food and Drug Administration of the province, Autonomous Region or Municipality directly under the Central Government where the manufacturers are located. As for the defects that can be eliminated by means of warning, checking, fixing, relabeling, or amending the devices’ user’s guide, update its software, replacement or destruction, such measures are be taken where the manufacturer is located. If in need of destruction, such measures should be taken under the supervision of the local Food and Drug Administration.Article 22After completing the recalling of medical devices, result evaluation should be carried out, and a summary report should be submitted to the Food and Drug Administration within 10 days.Article 23Investigations by the Food and Drug Administration Department should start within 10 days after receiving the summary report to evaluate the effects of the recall. Conclusions of the investigation and evaluation should be sent formally to the manufacturers and copied to the parallel leveled Health Administration Department. If the elimination of the defects is still considered ineffective after the investigation and evaluation, manufacturers should be required to reprocess the recalling procedure under the command of the Food and Drug Administration Department.Chapter 4Mandatory RecallArticle 24After the investigation and evaluation of the Food and Drug Administration Department, if the defects referred to in Article 4 still exist, and Active Recall nevertook place actively by the manufacturers, mandatory recall are to be activated.Food and Drug Administration Department should require the immediate suspension of sales and usage of the devices.Article 25A notice should be sent to the manufacturers or the appointed Chinese agencies of imported manufacturers when decision of mandatory recall is made. The notice should include the following information:1.Detailed information of the recalled medical devices, including basicinformation such as the names and batch;2.The reason for the recall;3.The results of the investigation and evaluation;4.The requirements of the recall, including its extent and time limit.Article 26Upon receiving the notice of the recall, the manufacturers of medical devices should formulate, submit and help carry out the recalling proposal, as well as inform the companies or individuals that run business with or make use of the medical devices according to Article 15 and 16.Article 27The manufacturers should report the recall related matters to the Food and Drug Administration Department according to this regulation Article19, 20, 21, 22, and handle the follow-up pressures.The Food and Drug Administration Department should investigate the report according to Article 23, evaluate the result of the recall, and report to the Health Administration Department of parallel level. After the investigation and evaluation, if there are still defects that are considered not effectively eliminated, a new recall should be activated accordingly by the Food and Drug Administration Department.Chapter 5Legal ResponsibilitiesArticle 28If defects of marketed devices are confirmed by the Food and Drug AdministrationDepartment due to violation of law, regulations or rules, administrative sanctions upon the manufacturers should take place in accordance of the law or regulation. For the companies actively eliminate or alleviate the harms occurred, a lesser or reduced punishment should be taken into action in accordance to the Law of Administrative Penalties; if the illegal activities are minor and are corrected promptly, with no harms done, they can go unpunished.No exemptions of other legal responsibilities should occur when the manufacturers are to recall their medical devices.Article 29In violation of this regulation such as, the manufacturers not actively recalling the devices when defects are detected, mandatory measures are to activate, with a penalty of 3 times the price of the supposed to be recalled devices; in case of serious consequences, the certificate for medical device should be revoked by the original authorization department, until the revocation of medical device registration record.Article 30In violation of Article 24, the manufacturers refuse to recall the devices, a penalty of 3 times the price of the supposed to be recalled devices is to be charged; in case of serious consequences, the certificate for medical device should be revoked by the original authorization department, until the revocation of medical device registration record.Article 31In case of any circumstances listed below, the manufacturers should receive warning, be granted a time limitation for the amendment, and be punished with a penalty of no more than 30,000 RMB;1.In violation of Article 15, a recalling notice of the medical devices is notforwarded to the companies or individuals that run business with or make use of the medical devices within provided time limit;2.In violation of Article 18, section 2 of Article 23, section 2 of Article 27, nocorrection or recalling measures are taken according to the regulations of Food and Drug Administration Department;3.In violation of Article 21, no detailed records of the handling of the recalleddevices are kept, or not reporting to the Food and Drug Administration Department.Article 32The manufacturers should receive warning, mandatory correction order in case of the occurrence of circumstances below, and for the ones not corrected after the time limitation, a penalty of no more than 30,000RMB should be charged.1.Not establishing the recalling system according to this regulation;2.Refusing to assist with investigation of the Food and Drug AdministrationDepartment;3.Not submitting the Report of Device recalled incidents, recalling scheduleand investigation evaluation, the enforcement and summary of the recall of medical devices;4.Modification of the recall schedule, but not yet reported to Food and DrugAdministration Department.Article 33Companies dealing and operating the medical Devices in violation of Article 7, section 1, will be forced to cease the selling or using the defective devices, and will be fined a penalty of over 1,000 and no more than 30,000 RMB; if caused serious consequences, their medical devices business certificate will be suspended by the authorization department.Article 34For companies dealing and operating the medical Devices that refuse to cooperate with the detection of the defects, or assist the manufacturing company with the recall of the devices, a warning of immediate correction will be given; if not, a fine of no more than 30,000 RMB will be charged.Article 35Employees at the Food and Drug Administration Department in violation of their duties or abuse their authorities, will take equivalent punishment.Chapter 6Supplementary ArticlesArticle 36On condition that the medical device to be recalled has already been planted into the patient, the manufacturing company should reach an agreement with the medical institution according to the various reasons, and purpose a solution.Article 37The patients can claim for damages caused by the medical devices from the manufacturing, dealing or operating companies. The dealing and operating companies have the right to pursue compensation from the manufacturing company after granting their compensation to the patients.Article 38This regulation takes effect since July 1st, 2011.Appendix: 1. Report of Device recalled incidents2. Report of the Enforcement of recall scheduleReport company：（stamp）Responsible person（Signature）Reporter:（Signature）Date of Report:Report of the Enforcement of recall scheduleReport company：（stamp）Responsible person（Signature）Reporter:（Signature）Date of Report:。