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医疗器械召回管理办法(试行)医疗器械召回管理办法(试行)第一章总则第一条为了加强对医疗器械召回工作的管理，保障公众的生命健康安全，根据《中华人民共和国医疗器械监督管理条例》等相关法律法规，并结合我国医疗器械行业的实际情况，制定本办法。
第二条本办法适用于在我国境内生产、进口、销售和使用的医疗器械召回工作。
召回的医疗器械包括已经流通到市场和已经使用的医疗器械。
第三条医疗器械召回应当符合风险评估的结果，以保障公众的生命健康安全为基础，依法合规、科学有效进行。
第四条医疗器械召回涉及的责任主体包括生产企业、进口企业、经销商和医疗机构等。
第二章召回范围和程序第五条医疗器械的召回范围包括但不限于以下情况：1、医疗器械存在缺陷或有安全隐患，可能对人身安全造成威胁；2、已被批准、注册的医疗器械在生产、进口、销售和使用过程中发生问题，尚未出现事故或事故尚未造成严重后果。
第六条生产企业、进口企业应当建立医疗器械召回制度，明确召回责任、流程和程序，定期进行召回演练。
第七条当监管部门或企业自行发现医疗器械存在缺陷或安全隐患，需进行召回时，应当按照以下程序进行：1、提出召回申请，包括召回方案、召回期限等；2、经监管部门审核同意后，向相关企业发出召回通知书；3、相关企业接到召回通知书后，应当立即采取行动，按照要求进行召回，并在规定的期限内完成。
第三章召回责任和义务第八条生产企业、进口企业是召回的责任主体，应当履行以下义务：1、确定召回责任人员，明确职责和权限，做好召回工作的组织领导；2、制定召回方案，并向监管部门报告；3、向受影响方提供召回通知书，说明召回的原因、范围和措施；4、按照召回计划，及时组织采取措施，回收召回的医疗器械，并对已使用的医疗器械进行必要的处理；5、持续跟踪召回工作进展，向监管部门及时报告。
第九条经销商和医疗机构是召回的协助对象，应当履行以下义务：1、接到召回通知后，立即停止销售和使用相关医疗器械，并配合生产企业、进口企业进行召回工作；2、协助生产企业、进口企业对已销售或使用的医疗器械进行回收和处理；3、按照要求报告召回工作进展。
RegulationsRegulations for the Supervision and Administration ofMedical DevicesRegulations for the Supervision and Administration of Medical DevicesChapter I General ProvisionsArticle 1 These Regulations are hereby formulated with a view to strengthening the supervision and administration of medical devices， ensuring their safety andeffectiveness and protecting human health and life safety。
Article 2 All units or individuals engaged in the research and development， production，distribution， use, supervision and administration of medical devices within the territory of the Peoples Republic of China shall comply with the Regulation.Article 3 ”Medical devices” as defined by these regulations refers to： any instrument，apparatus， appliance, material, or other article whether used alone or in combination, including the software necessary for its proper application。
医疗器械召回管理办法医疗器械召回管理办法第一章总则第一条为规范医疗器械召回工作，保障患者和公众的安全和健康，根据相关法律、法规和政策规定，制定本办法。
第二条医疗器械召回是指生产企业或者经营企业发现医疗器械存在缺陷或者不符合安全技术标准的情况，主动采取措施防止潜在风险，包括召回、修改、替换等行为。
第二章召回工作的组织与管理第三条医疗器械生产企业应当建立医疗器械召回的组织与管理机构，明确召回工作的责任人员和相关部门。
第四条医疗器械召回工作应当有专门的工作计划和方案，明确召回的目标、范围和方式，并且应当及时向相关部门报备。
第五条医疗器械生产企业应当建立健全召回工作的监测和评估机制，对召回的效果进行评估，并及时采取改进措施。
第三章召回的程序与要求第六条医疗器械召回应当明确召回的程序和要求，包括但不限于以下内容：1. 召回通知的发布：医疗器械生产企业应当在媒体、互联网以及医疗器械经营企业的官方网站上发布召回通知，并向相关部门报备。
2. 召回范围的确定：医疗器械生产企业应当根据召回的目的和情况，确定召回的范围，包括型号、批号、生产日期等信息。
3. 召回风险和控制措施：医疗器械生产企业应当对召回的风险进行评估，并采取相应的控制措施，如修复、更换等。
第四章监督与处罚第七条监督部门应当对医疗器械召回工作进行监督和检查，发现问题及时采取措施。
第八条对于不按照规定进行召回或者故意隐瞒或者误导召回信息的，监督部门应当依法予以处罚，并向公众发布。
第五章附则第九条本办法自XXXX年XX月XX日起施行。
附件：1. 医疗器械召回风险评估表2. 医疗器械召回通知模板3. 医疗器械召回工作计划模板法律名词及注释：1. 医疗器械：指用于预防、诊断、治疗、缓解或者控制人体病症、损伤或者残疾的设备、仪器、物品、材料或者其他类似的用品。
2. 召回：医疗器械生产企业或者经营企业发现医疗器械存在缺陷或者不符合安全技术标准的情况时，主动采取措施防止潜在风险的行为。
医疗器械监督管理条例英文版Regulations on the Supervision and Administration of Medical Devices (English Version)Chapter 1: General ProvisionsArticle 1: These Regulations are formulated to strengthen the supervision and administration of medical devices, ensure their quality and safety, and protect the health and safety of patients and users.Article 2: These Regulations apply to the supervision and administration of medical devices within the territory of the People's Republic of China.Article 3: The State Drug Administration (SDA) is responsible for the supervision and administration of medical devices nationwide. The drug regulatory departments of provinces, autonomous regions, and municipalities directly under the Central Government are responsible for the supervision and administration of medical devices within their respective administrative regions.Chapter 2: Classification and Registration of Medical DevicesArticle 4: Medical devices are divided into three classes: Class I, Class II, and Class III, based on their potential risks to human health.Article 5: Class I medical devices are subject to registration with the SDA or its authorized departments. Class II and Class III medical devices shall obtain a registration certificate from the SDA or its authorized departments before they can be marketed or used.Article 6: The registration of medical devices shall adhere to the principles of scientific evaluation, risk classification, and lifecycle management. The registration procedures and requirements shall be determined by the SDA.Chapter 3: Production and Operation of Medical DevicesArticle 7: The production and operation of medical devices shall comply with relevant laws and regulations, as well as technical standards and requirements.Article 8: Medical device manufacturers shall establish a quality management system in accordance with the Good Manufacturing Practice (GMP) for medical devices. They shall also obtain a Medical Device Manufacturing License before engaging in production activities.Article 9: Medical devices shall be labelled with clear and accurate information, including the name, specifications, model, production date, expiration date, and manufacturer's information.Chapter 4: Clinical Trials and Adverse Event ReportingArticle 10: Clinical trials of medical devices shall be conducted in accordance with the provisions of the relevant regulations. The responsible party shall submit a clinical trial application to the SDA or its authorized departments for approval.Article 11: Any adverse event or abnormal reaction occurring during the use of medical devices shall be reported to the SDA or its authorized departments within the specified time limit.Article 12: Medical device manufacturers and users shall establish a system for monitoring and reporting adverse events. The SDA shall organize the collection, analysis, and evaluation of adverse event information to improve the safety of medical devices.Chapter 5: Supervision and InspectionArticle 13: The SDA and its authorized departments have the authority to conduct supervision and inspection of medical device production, operation, distribution, and use. Relevant units and individuals shall cooperate and provide necessary support during the inspection.Article 14: The SDA and its authorized departments have the power to order the suspension of production, operation, distribution, and use of medical devices that fail to meet the requirements, pose risks to human health, or are suspected of being counterfeit or substandard.Chapter 6: Legal LiabilityArticle 15: Any violation of these Regulations shall be dealt with in accordance with the Drug Administration Law of the People's Republic of China and other relevant laws and regulations.Article 16: Violators who engage in the production and operation of medical devices without obtaining the necessary licenses or registrations shall be subject to administrative penalties, such as fines and confiscation of illegal income. In serious cases, criminal liability shall be pursued.Chapter 7: Supplementary ProvisionsArticle 17: These Regulations shall come into effect on the date of promulgation. The Regulations on the Supervision and Administration of Medical Devices issued by the State Council on January 1, 2002, shall be repealed simultaneously.Article 18: The SDA is responsible for the interpretation of these Regulations.Note: This English version is a translated version for reference purposes only. In case of any discrepancies between the Chinese version and this English version, the Chinese version shall prevail.。
2024年医疗器械安全监管条例英文版Title: Regulations on Medical Device Safety Supervision in 2024In 2024, new regulations on medical device safety supervision will be implemented to enhance the quality and safety standards of medical devices. These regulations aim to protect public health and ensure that medical devices meet the necessary safety requirements.The regulations will cover various aspects of medical device safety, including manufacturing standards, quality control measures, post-market surveillance, and reporting of adverse events. Manufacturers will be required to comply with these regulations to ensure that their products are safe for use by patients.Additionally, the regulations will establish a framework for regulatory authorities to monitor and supervise the safety of medical devices in the market. This will involve conducting regular inspections,audits, and reviews of manufacturers to ensure compliance with safety standards.Furthermore, the regulations will include provisions for the reporting of adverse events related to medical devices. Manufacturers, healthcare providers, and patients will be required to report any incidents of device malfunction, injury, or death to the regulatory authorities for investigation.Overall, the regulations on medical device safety supervision in 2024 will play a crucial role in ensuring the quality and safety of medical devices in the market. By upholding stringent safety standards and regulatory oversight, these regulations will help protect patients and promote public health.。
The Measures for the Administration of Medical Device Registration were passed by State Food and Drug Administration at the administration affairs meeting on May 28, 2004 and are hereby promulgated for implementation as of the date of promulgation.Director general: Zheng XiaoyuAug. 9, 2004Measures for the Administration of Medical Device RegistrationChapter 1. General ProvisionsArticle 1These Measures are formulated in accordance with the Regulations on the Supervision and Administration of Medical Devices to standardize the administration of medical device registration and guarantee the safety and effectiveness of medical devices.Article 2All the medical devices sold and used within the territory of the People’s Republic of China shall be subject to application for registration in accordance with the provisions of these Measures. The medical devices whose registration fails to be approved shall not be sold or used.Article 3Medical device registration means the process of systematic evaluation of the safety and effectiveness of the medical devices to be sold and used in accordance with the legal procedures to decide whether the sale and use of such medical devices can be approved.Article 4China implements classified registration and administration of medical devices.Category I domestic medical devices are subject to examination by municipal level (food) drug administration authorities of the administrative areas with districts, and medical device registration certificates will be issued after approval by such authorities.Category II domestic medical devices are subject to examination by the (food) drug administration authorities of provinces, autonomous regions and municipalities, and medical device registration certificates will be issued after approval by such authorities.Category III domestic medical devices are subject to examination by the State Food and Drug Administration (SFDA), and medical device registration certificates will beissued after approval by SFDA.Foreign medical devices are subject to examination by SFDA, and medical device registration certificates will be issued after approval by SFDA.Unless otherwise specified hereunder, medical devices from Taiwan, Hong Kong and Macao shall be registered by reference to the measures for the registration of foreign medical devices.The valid period of each medical device registration certificate shall be four years. Article 5Medical device registration certificates shall be printed by SFDA in a centralized way, while the corresponding contents shall be completed by the (food) drug administration authorities responsible for examination and registration.Registration numbers shall be arranged in the following form:×(×)1(S)YJX(×2)Z××××3 No. ×4××5××××6, where,×1 shall mean the abbreviation of the place where the registration examination and approval authority is located:The letter “G” shall be adopted for Category III domestic medical devices, foreign medical devices and medical devices from Taiwan, Hong Kong and Macao;The abbreviation of the province, autonomous region or municipality where the registration examination and approval authority is located shall be adopted for Category II medical devices;The abbreviation of the province, autonomous region or municipality where the registration examination and approval authority is located plus the abbreviation of the local municipal level administrative area with districts shall be adopted in the form of ××1 for Category I domestic medical devices (only the abbreviations of the local province, autonomous region or municipality shall be adopted if there is no corresponding municipal level administrative area with districts);×2 shall indicate the form of registration (Z [approval], J [import] and X [permit]): “Z” is applicable to domestic medical devices;“J” is applicable to foreign medical devices;“X” is applicable to medical devices from Taiwan, Hong Kong and Macao;××××3 shall indicate the year of approval for registration;×4 shall indicate the category of product administration;××5 shall indicate the type code of product; and××××6 shall indicate the serial number of registration.The medical device registration record (see Appendix 1 of these Measures) attached to each medical device registration certificate shall be used together with the medical device registration certificate.Article 6A manufacturer applying for medical device registration shall undertake the corresponding legal obligations and hold a medical device registration certificate after the application is approved.The person handling the matters related to application for medical device registration shall be subject to authorization by the manufacturer, have the corresponding professional knowledge and be familiar with the laws, rules, regulations and technical requirements on the administration of medical device registration.Regarding application for the registration of foreign medical devices, the foreign manufacturer shall designate an organization located within the territory of China to act as the foreign manuf acturer’s agent, who shall undertake the corresponding legal liability. The foreign manufacturer shall also entrust a corporate organization that is located within the territory of China and has the corresponding qualifications or entrust the manufacturer’s organ in China to undertake after-sale service for the medical devices.Article 7The medical device under application for registration shall have an applicable product standard, which may adopt a national standard, a professional standard or a registered product standard formulated by the manufacturer, but the registered product standard shall not be inferior to the relevant national standard or professional standard.Registered product standards shall be formulated in accordance with the requirements of SFDA for the administration of the standards of medical devices.Article 8When a manufacturer applies for the registration of a Category II or III medical device, the manufacturer shall satisfy the production conditions specified by SFDA or meet the requirements of the relevant quality system.Chapter 2. Test for Medical Device RegistrationArticle 9Categories II and III medical devices are subject to registration test by the medical device test organizations recognized by SFDA and the General Administration of Quality Supervision, Inspection and Quarantine. Such medical devices shall be proved conforming to the applicable product standards through test before the medical devices are used for clinical trial or an application is submitted for registration.The list of the medical device test organizations recognized by SFDA and the General Administration of Quality Supervision, Inspection and Quarantine (hereinafterreferred to “medical device test organizations”) will be separately announced.Article 10The medical device test organizations shall conduct registration test to the proposed products and issue test reports within the scope of test approved by SFDA and the General Administration of Quality Supervision, Inspection and Quarantine and in accordance with the product standards proposed by the manufacturers (including the applicable national standards, professional standards or the registered product standards formulated by the manufacturers).For the medical devices that have not been included in the authorized scope of test by the medical device test organizations, the corresponding registration examination and approval authority shall designate a test organization with the necessary test capacity to test such medical devices.The registration test of foreign medical devices shall be conducted in accordance with the Regulations on the Registration Test of Foreign Medical Devices.Article 11The tested products in a same registration unit shall be typical products that can represent the safety and effectiveness of the other products in this registration unit. Article 12The similar products manufactured by a same manufacturer with the same raw materials may not be subject to biological compatibility test during the biological evaluation of the products for re-registration, provided that the production technology and the expected purpose of the products remain unchanged.The similar products manufactured by a same manufacturer with raw materials that have passed biological evaluation may not be subject to biological compatibility test during the biological evaluation of the products for registration, provided that the production technology and the expected purpose of the products remain unchanged or there are no new potential biological risks.Article 13Application for the registration of a Category II or III medical device may be exempted from registration test if this medical device can satisfy all the following conditions:(1)The basic principle, main function, structure, material, material quality andexpected purpose of the medical device under application for registration are same as those of the manufacturer’s medical device that has already been approved for registration;(2)The manufacturer has passed the examination of quality management standard formedical device manufacturing or has passed the certification of quality system for medical devices, and the manufacturer can provide a test report recognized by theoriginal production condition examination authority;(3)The medical device under application for registration has seen no changes relatedto safety and effectiveness as compared with the manufacturer’s similar product that has already been approved for registration and has passed registration test, or though there are changes related to safety and effectiveness, the changed parts and the other parts of the product with subsequent changes related to safety and effectiveness have passed test by a medical device test organization;(4)The manufacturer’s similar product that has already been approved forregistration has seen no adverse events during the monitoring of the adverse events of medical devices in accordance with the relevant regulations;(5)The manufacturer’s similar product that has already been approved forregistration has no record of nonconformities as determined by the (food) drug administration authority during selective examination for product quality supervision within one year; and(6)If the medical device under application is a foreign medical device, the sale of themedical device has been approved by the medical device administration authority of the relevant foreign government.Article 14Application for the re-registration of a Category II or III medical device may be exempted from registration test if this medical device can satisfy all the following conditions:(1)The basic principle, main function, structure, material, material quality andexpected purpose of the medical device under application for registration are same as those of the manufacturer’s medical device that has already been approved for registration;(2)The manufacturer has passed the examination of quality management standard formedical device manufacturing or has passed the certification of quality system for medical devices, and the manufacturer can provide a test report recognized by the original production condition examination authority;(3)The medical device under application for re-registration has seen no changesrelated to safety and effectiveness as compared with the originally registered product that has passed registration test, or though there are changes related to safety and effectiveness, the changed parts and the other parts of the product with subsequent changes related to safety and effectiveness have passed test by a medical device test organization;(4)The medical device under application for re-registration has seen no adverseevents during the monitoring of the adverse events of medical devices in accordance with the relevant regulations within the valid period of the original medical device registration certificate; and(5)The originally registered medical device has no record of nonconformities asdetermined by the (food) drug administration authority during selective examination for product quality supervision within one year.Article 15An application for the postponement of test may be submitted for large medical devices that have obtained sales approval from the medical device administration authority of the relevant foreign government, have special requirements for the site of installation and are difficult to be tested, and supplementary test shall be conducted for such medical devices after a medical device registration certificate is obtained.For a product that is under application for the postponement of test and has been approved for registration in accordance with the provision of the above paragraph, the manufacturer must complete registration test after the first medical device is imported and before the medical device is put into use. The medical device shall not be used until the end of satisfactory test.Chapter 3. Clinical Trial of Medical DevicesArticle 16Clinical trial documents shall be submitted for application for the registration of Categories II and III medical devices.Clinical trial documents shall be submitted in the manner specified in the Classified Regulations on Clinical Trial Documents for Medical Device Registration (see Appendix 12 of these Measures).Article 17The Regulations on the Clinical Trial of Medical Devices shall be strictly followed for the medical devices whose clinical trial is conducted within the territory of China. Article 18The clinical trial documents for a medical device whose clinical trial is conducted within the territory of China shall include a contract for clinical trial, a plan of clinical trial and a report of clinical trial.When it’s necessary at the (food) drug administration authority’s discretion, the (food) drug administration authority may ask the manufacturer to submit the instructions on clinical trial, the letter of consent to clinical trial and the original record of clinical trial.Chapter 4. Application for and Examination and Approval ofMedical Device RegistrationArticle 19To apply for medical device registration, the applicant shall, according to the classification of medical devices, submit an application to the corresponding (food)drug administration authority in accordance with the provisions of Article 4 of these Measures. The applicant shall complete a written application for medical device registration and submit application documents in accordance with the corresponding requirements of Appendix 2, 3, 6, 8 or 9 of these Measures. The application documents shall be made in Chinese; and the application documents translated on the basis of foreign documents shall be accompanied by the original documents.The manual of medical device submitted by the applicant shall conform to the Regulations on the Administration of the Manuals, Labels and Packing Marks of Medical Devices.The applicant shall be responsible for the truthfulness of all the contents of the application documents submitted by it.Article 20After a (food) drug administration authority receives an application, this authority shall dispose of the application respectively according to the following circumstances: (1)If the matter under application is beyond the limits of the (food) drugadministration authority’s functions and powers, the (food) drug administration authority shall immediately decide to reject the application and notify the applicant to apply to the relevant administration authority;(2)If the application documents have mistakes that can be corrected on the spot, the(food) drug administration authority shall allow the applicant to correct the mistakes on the spot;(3)If the application documents are incomplete or do not meet the requirements offormal examination, the (food) drug administration authority shall issue a notice for the supplementation or correction of documents to the applicant on the spot or within five working days to inform the applicant of all the contents that need to be supplemented or corrected once and for all; the application documents shall be deemed to have been accepted from the date of receipt if the (food) drug administration authority fails to inform the applicant of the contents that need supplementation or correction within the time limit; or(4)The (food) drug administration authority shall accept the application documentsif the application documents are complete and meet the requirements of formal examination or the applicant has submitted all the necessary supplementary or corrective documents in accordance with the requirements.After accepting or rejecting an application for medical device registration, the (food) drug administration authority shall issue a notice of acceptance or a notice of rejection that is affixed with the (food) drug administration authority’s special seal and dated. Article 21After a (food) drug administration authority accepts an application for medical device registration, the (food) drug administration authority shall conduct substantiveexamination of the application and make a written decision on whether to register the medical device under application for medical device registration. If the application is proved conforming to the regulations through examination and registration is approved, the (food) drug administration authority shall issue a medical device registration certificate to the applicant within 10 working days after the written decision of approval is made. If the application is proved nonconforming to the regulations, the (food) drug administration authority shall make a written decision of no registration, indicate the reason and inform the applicant of its right to apply for administrative reconsideration or bring an administrative lawsuit according to law.Article 22The municipal level (food) drug administration authority of an administrative area with districts shall decide to approve registration or not within 30 working days after accepting an application.The (food) drug administration authority of a province, autonomous region or municipality shall decide whether to approve registration or not within 60 working days after accepting an application.SFDA shall decide whether to approve registration or not within 90 working days after accepting an application.If test, expert evaluation or hearing is needed during the examination of an application for registration, the period of test, expert evaluation or hearing shall not be included in the time limit specified in this Article. The (food) drug administration authority shall notify the applicant of the said period needed by writing.Article 23Application for the registration of a foreign medical device that has obtained no foreign sales license for medical devices shall be examined in accordance with the requirements of technical examination for the registration of similar domestic products (See Appendixes 8 and 9 of these Measures for the documents that need to be submitted).Article 24During the technical examination of application documents for medical device registration, if the (food) drug administration authority finds that the manufacturer needs to supplement documents, the (food) drug administration authority shall issue a notice for the supplementation of documents once and for all.The manufacturer shall fully supplement the necessary documents once and for all within 60 working days in accordance with the requirements of the notice. The period used for supplementing materials shall not be included in the time limit for substantive examination by the (food) drug administration authority. The examination shall be terminated if the manufacturer fails to submit supplementary documents within the specified time limit without justified reasons.Article 25In case the examination of application for registration is terminated, the manufacturer shall put forth no new application within six months after the termination.Article 26If the manufacturer has any objection to the content of the notice for supplementing documents, the manufacturer may put forth its written opinions to the (food) drug administration authority within the specified time limit, indicate the reason of objection and provide technical support documents. The (food) drug administration authority shall make a decision after examining the documents submitted by the manufacturer.Article 27The registration units of medical devices shall be divided according to technical structures, performance indexes and expected purposes in principle.Article 28For a medical device that is registered as a component, the applicant shall indicate the name, model and specifications of the product or component recommended for use together with the medical device.The procedures of complete device registration must be gone through for a complete device that is composed of components that have been approved for registration.For a medical device that is registered as a complete device, a list of its major components shall be provided during application for registration. The complete device shall be registered anew after the performance and specifications of a major component are changed.A medical device that is registered as a complete device may be exempted from separate registration provided that the medical device’s components set forth in the column “Performance, Structure and Components of the Product” in the attached table of the registration certificate for the medical device can be separately sold on the condition of no changes in the form of assembly and the expected purpose.Article 29A (food) drug administration authority shall make public the necessary conditions, procedure and time limit for the corresponding medical device registration, a list of all the documents that need to be submitted and a demonstrative text of application in the administration authority’s website and the medical device registration office.Article 30A (food) drug administration authority shall make public the process and the result of examination and approval during the examination of an application for medical device registration. The applicant and the interested party may present their opinions anddefend themselves on the matters directly related to their major interests.Article 31SFDA shall regularly announce in its website the catalogue of the medical devices that have been approved for registration for public consultation.Article 32In case an application for medical device registration directly touches upon the relationship of major interests between the applicant and another party, the (food) drug administration authority shall tell the applicant and the interested party that they have the right to apply for hearing in accordance with laws, regulations and the other regulations of SFDA; during the examination of an application for medical device registration, the (food) drug administration authority shall publicly announce and hold a hearing of the major licensing matters that touch upon public interests at the (food) drug administration authority’s discretion.Chapter 5. Re-registration of Medical DevicesArticle 33If a manufacturer holding a medical device registration certificate needs to continuously sell or use the relevant medical device after the registration certificate expires, this manufacturer shall apply for re-registration within six months before the valid period of the medical device registration certificate expires. If the manufacturer fails to apply for re-registration within the time limit, the product shall be subject to registration test for re-registration.Article 34In case any of the following items in a medical device registration certificate is changed, the manufacturer shall apply for re-registration of the relevant product within 30 days from the date of change:(1)Model;(2)Address of manufacturing site;(3)Product standard;(4)Performance, structure and components of the product; or(5)Indications.Article 35If the category of product administration is changed within the valid period of the medical device registration certificate, the manufacturer shall, according to the category after change, apply to the corresponding (food) drug administration authority for re-registration within six months.Article 36To apply for the re-registration of a medical device, the applicant shall complete a written application for medical device registration and submit the application documents to the (food) drug administration authority in accordance with the corresponding requirements of Appendix 4, 5 or 7 of these Measures.The relevant provisions of Chapter 4 of these Measures shall apply to the procedures of application acceptance, examination and approval for re-registration if such procedures are not separately specified in this Chapter.Article 37A medical device shall not be reregistered in any of the following circumstances:(1)The applicant fails to meet the requirements specified by the (food) drugadministration authority in accordance with SFDA’s relevant regulations at the time of approval for sale;(2)The medical device is obsolete as indicated by the result of reevaluation by SFDA;or(3)The medical device registration certificate for the medical device has beencancelled in accordance with the Regulations on the Supervision and Administration of Medical Devices.Chapter 6. Modification and Re-issuance of Medical DeviceRegistration CertificateArticle 38In case the items in a medical device registration certificate see any of the following changes, the manufacturer shall apply for the modification of medical device registration certificate within 30 days after the date of change:(1)Change of the manufacturer’s name but no change of the manufacturer’s entity;(2)Change of the manufacturer’s registered address;(3)Literal change of the address of manufacturing site;(4)Literal change of product name or trade name;(5)Literal change of model or specifications;(6)Literal change of the name or code of product standard;(7)Change of agent; or(8)Change of after-sale service provider.Article 39To apply for the modification of a medical device registration certificate, the applicantshall complete an written application for the modification of medical device registration certificate and submit the relevant documents and explanations to the original registration examination and approval authority in accordance with the requirements of Appendix 10 of these Measures. The original registration examination and approval authority shall conduct formal examination of the application documents and inform the applicant of all the contents that need to be supplemented or corrected once and for all on the spot or within five working days. A notice of acceptance shall be issued to the applicant if the application documents meet the requirements.Article 40The original registration examination and approval authority shall decide by writing whether to approve the modification or not within 20 working days after accepting the application. If the modification is proved conforming to the regulations through examination, the original registration examination and approval authority shall issue a modified medical device registration certificate and nullify the original one. If the modification is proved nonconforming to the regulations through examination, the original registration examination and approval authority shall decide by writing to reject the application for modification, indicate the reason and tell the applicant that it has the right to apply for administrative reconsideration or bring an administrative lawsuit according to law.The modified medical device registration certificate shall adopt the original serial num ber, and the word “Modified” in brackets shall be added at the end of the serial number.The expiry date of the modified medical device registration certificate shall be same as that of the original certificate, and the certificate holder shall apply for re-registration upon expiry of the valid period.Article 41In case a manufacturer’s medical device registration certificate is lost or damaged, the manufacturer shall apply to the original registration examination and approval authority for re-issuance by submitting the relevant documents and explanations in accordance with the requirements of Appendix 11 of these Measures.Chapter 7. Supervision and AdministrationArticle 42The (food) drug administration authorities in charge of examination and approval for medical device registration shall conduct examination and approval in accordance with the specified procedures and decide whether to approve registration or not. Those who approve registration in violation of the regulations shall undertake the relevant administrative liability.Article 43In case a local (food) drug administration authority at municipal level or above of an。
医疗器械召回记录范文英文回答：Medical Device Recall Records Template.Purpose:To provide a structured and comprehensive record of medical device recalls to ensure patient safety and regulatory compliance.Essential Information:Device Name: The name of the medical device being recalled.Device Model and Serial Number Range: The specific models and serial numbers of the affected devices.Recall Date: The date the recall was issued.Reason for Recall: Clearly state the reason for the recall, including any safety concerns or performance issues.Potential Hazards: Describe the potential hazards associated with using the affected devices.Instructions for Affected Users: Provide clear and concise instructions on how affected users should handlethe recalled devices, including any necessary actions or precautions.Corrective Actions: Outline the corrective actions being taken to address the recall, such as device replacement or repair.Distribution List: Maintain a list of all individuals and organizations notified of the recall.Follow-Up: Record any follow-up activities related to the recall, such as tracking device returns or providing additional information to affected users.Additional Considerations:Regulatory Requirements: Ensure the recall record complies with all applicable regulatory requirements.Documentation: Maintain accurate and up-to-date documentation of the recall process.Communication: Communicate the recall effectively to affected users and stakeholders.Confidentiality: Treat any sensitive information related to the recall with the utmost confidentiality.Legal Consequences: Be aware of any potential legal consequences associated with improper recall procedures.中文回答：医疗器械召回记录模板。
医疗器械召回管理办法医疗器械召回管理办法是指针对不符合法律法规要求、存在安全风险的医疗器械，制定一系列召回措施和管理办法，以保障公众的健康和生命安全。
下面将从召回的定义、召回的程序、召回的分类、召回的责任等方面对医疗器械召回管理办法进行详细阐述。
一、召回的定义医疗器械召回是指制造商或经销商在发现自己所生产或销售的医疗器械存在缺陷或存在安全隐患时，采取一系列必要措施，包括但不限于通知、修理、更换、退货等，追回已经流入市场和使用的医疗器械，以消除或减少对使用者的危害。
二、召回的程序1.发现召回的依据：当制造商或经销商发现医疗器械存在缺陷或安全隐患时，应当及时向相关部门报告，提供必要的证据和信息。
2.召回计划的制定：制造商或经销商应当在第一时间制定召回计划，明确召回的范围、流程、时间节点等信息。
3.召回通知的发布：制造商或经销商应当通过合适的媒体渠道发布召回通知，明确召回的原因、批次、型号等信息，提醒用户停止使用召回器械，并采取后续措施。
4.召回结果的报告：制造商或经销商应当在召回结束后向相关部门报告召回的结果，包括召回的数量、召回的范围、召回措施的实施情况等。
三、召回的分类根据医疗器械召回管理办法的规定，医疗器械召回分为三类：一般召回、重大召回和紧急召回。
1.一般召回：由于医疗器械存在一些缺陷或风险，但不会对使用者的生命和健康构成重大威胁。
制造商或经销商应当根据召回计划，进行逐步的通知、修理、更换等措施。
2.重大召回：由于医疗器械存在严重缺陷或风险，可能对使用者的生命和健康构成潜在威胁。
制造商或经销商应当立即采取紧急召回的措施，及时通知用户停止使用，并采取必要的修理、更换等措施。
3.紧急召回：由于医疗器械存在严重缺陷或风险，对使用者的生命和健康构成直接威胁，需要立即召回。
制造商或经销商应当立即发布召回通知，并采取紧急措施，如紧急停止销售、紧急修理、紧急更换等。
四、召回的责任1.制造商责任：制造商应当承担主要的召回责任，包括监测市场上的医疗器械质量，建立健全召回制度，及时发现并通报存在风险的医疗器械，并按照召回管理办法进行召回。
医疗器械产品召回管理办法医疗器械产品召回管理办法一、总则医疗器械产品召回管理办法（以下简称“办法”）旨在规定医疗器械生产企业在发现产品存在质量安全问题时，主动采取召回措施，保障公众生命健康安全的管理办法。
二、召回责任主体1.医疗器械生产企业应当建立完善的质量管理体系，并设立专门的召回管理部门负责召回工作。
2.经营企业在销售医疗器械产品时，应当加强对产品质量的监控和控制，并及时向生产企业报告质量问题。
三、召回信息发布1.召回企业应当在发现产品存在质量安全问题后，立即向国家药品监督管理部门报告，并公开发布召回信息。
2.召回信息应当包括但不限于以下内容：产品名称、型号、召回原因、召回范围、召回期限、召回措施等。
四、召回措施1.召回企业应当制定详细的召回方案，并报国家药品监督管理部门备案。
2.召回措施包括但不限于以下内容：召回方式、召回通知、召回代理机构的选择、召回期限、召回费用承担等。
五、召回跟踪与处理1.召回企业应当建立召回产品追溯体系，追踪召回产品的去向，并对召回产品进行处理和销毁，确保产品不再流入市场。
2.经营企业应当全程配合召回企业的工作，积极协助召回工作的开展。
六、处罚与监督1.对违反召回管理办法的企业，国家药品监督管理部门有权采取相应的处罚措施。
2.国家药品监督管理部门将加强对医疗器械召回工作的监督，确保执行力度和效果。
七、附件1.召回通知书范本：包括召回通知书的内容和格式样本。
2.召回方案模板：包括召回方案的制定要点和模板示例。
3.召回报告模板：包括召回情况的报告要点和模板示例。
八、法律名词及注释1.医疗器械：指用于预防、诊断、治疗、缓解人体疾病、损伤或生理缺陷的器具、设备、材料或其他物品。
2.质量安全问题：指医疗器械产品在设计、研发、生产、销售、使用等环节中存在的与人体健康直接相关的安全隐患、设计缺陷、生产质量问题等。
3.召回范围：指召回企业确定的召回产品的销售时间、销售区域等范围。
《医疗器械召回管理办法（试行）》（卫生部令第82号）中华人民共和国卫生部令第82号《医疗器械召回管理办法（试行）》已于2010年6月28日经卫生部部务会议审议通过，现予以发布，自2011年7月1日起施行。
部长陈竺二○一一年五月二十日医疗器械召回管理办法（试行）第一章总则第一条为加强对医疗器械的监督管理，保障人体健康和生命安全，根据《医疗器械监督管理条例》、《国务院关于加强食品等产品安全监督管理的特别规定》，制定本办法。
第二条在中华人民共和国境内销售的医疗器械的召回及其监督管理，适用本办法。
第三条本办法所称医疗器械召回，是指医疗器械生产企业按照规定的程序对其已上市销售的存在缺陷的某一类别、型号或者批次的产品，采取警示、检查、修理、重新标签、修改并完善说明书、软件升级、替换、收回、销毁等方式消除缺陷的行为。
第四条本办法所称缺陷，是指医疗器械在正常使用情况下存在可能危及人体健康和生命安全的不合理的风险。
第五条医疗器械生产企业是控制与消除产品缺陷的主体，应当对其生产的产品安全负责。
第六条医疗器械生产企业应当按照本办法的规定建立和完善医疗器械召回制度，收集医疗器械安全的相关信息，对可能存在缺陷的医疗器械进行调查、评估，及时召回存在缺陷的医疗器械。
医疗器械经营企业、使用单位应当协助医疗器械生产企业履行召回义务，按照召回计划的要求及时传达、反馈医疗器械召回信息，控制和收回存在缺陷的医疗器械。
第七条医疗器械经营企业、使用单位发现其经营、使用的医疗器械存在缺陷的，应当立即暂停销售或者使用该医疗器械，及时通知医疗器械生产企业或者供货商，并向所在地省、自治区、直辖市药品监督管理部门报告；使用单位为医疗机构的，还应当同时向所在地省、自治区、直辖市卫生行政部门报告。
医疗器械经营企业、使用单位所在地省、自治区、直辖市药品监督管理部门收到报告后，应当及时通报医疗器械生产企业所在地省、自治区、直辖市药品监督管理部门。
第八条召回医疗器械的生产企业、进口医疗器械的境外制造厂商在中国境内指定的代理人所在地省、自治区、直辖市药品监督管理部门负责医疗器械召回的监督管理工作，其他省、自治区、直辖市药品监督管理部门应当配合、协助做好本辖区内医疗器械召回的有关工作。
医疗器械产品召回管理办法医疗器械产品召回管理办法第一章总则第一条为规范医疗器械产品召回活动，保障公众健康安全，根据《中华人民共和国药品管理法》和《医疗器械监督管理条例》，制定本办法。
第二条本办法适用于在中华人民共和国境内生产、销售、使用的医疗器械产品的召回活动。
第三条医疗器械产品召回应当以保障公众健康为宗旨，依法规范进行，及时、迅速、有效地组织实施。
第四条医疗器械产品召回应当遵循科学、公正、透明、便民的原则，促进企业、监管部门和消费者之间的密切合作与沟通。
第五条医疗器械产品召回的主体责任由召回企业负责，受理召回申请的省级药品监督管理部门负责指导、监督和管理。
第六条政府有关部门应当支持医疗器械产品召回工作，加强组织协调，提供必要的技术支持和人员培训。
第二章召回的类型和条件第七条医疗器械产品召回分为有序召回和紧急召回两种类型。
第八条有序召回是指对已经进入流通领域并存在安全隐患的医疗器械产品，召回企业与监管部门共同制定召回计划，按照计划有序进行召回的行为。
第九条紧急召回是指发现医疗器械产品存在严重危害公众健康的情况，召回企业应立即采取措施，与监管部门紧急协商并启动召回行动。
第十条医疗器械产品召回的条件包括：（1）产品存在缺陷，可能对公众健康产生危害；（2）医疗器械产品未能按照法律规定的标准进行生产、销售；（3）监管部门作出要求召回的决定。
第三章召回的程序与要求第十一条召回企业应当向受理召回申请的省级药品监督管理部门提交正式的召回申请，并提供相关证明材料和召回计划。
第十二条省级药品监督管理部门应当在受理召回申请之日起五个工作日内进行审核，审核通过后，发出召回通知书。
第十三条召回通知书应当包括召回产品的名称、型号、召回原因、召回范围、召回期限、召回方式、联系方式等内容，并要求召回企业向受影响的客户和用户发出召回通知。
第十四条召回企业应当按照召回通知书的要求，采取有效措施，及时、准确地通知受影响的客户和用户，并配合监管部门进行后续监督和检查。
医疗器械召回管理办法(修改)第一章总则第一条目的和依据根据《医疗器械监督管理法》和国家药品监督管理局相关规定，为加强医疗器械召回管理，保障公众健康和安全，制定本办法。
第二条适用范围本办法适用于在境内生产、经营、使用、进口的医疗器械召回活动。
第三条定义1. 医疗器械召回：指生产、经营者自行或由监管部门要求，对已上市或使用的医疗器械进行召回，并采取措施消除或减轻已存在的风险。
2. 召回管理人员：指医疗器械生产、经营者指派的具备相关资质和责任的人员，负责召回管理工作。
第二章召回的类型与级别第四条类型医疗器械召回分为主动召回和被动召回两种类型。
1. 主动召回：是指医疗器械生产、经营者根据监测情况或风险评估结果，自行决定召回医疗器械。
2. 被动召回：是指监管部门要求医疗器械生产、经营者进行召回。
第五条级别医疗器械召回的级别分为三级：一般级、较大级和严重级。
1. 一般级：指医疗器械存在一定风险，但影响较小，可以通过改善使用条件等方式进行控制。
2. 较大级：指医疗器械存在较大风险，需要通过召回进行消除或处理。
3. 严重级：指医疗器械存在严重风险，可能导致严重后果，需要立即采取措施进行召回。
第三章召回管理程序第六条召回管理人员的指派医疗器械生产、经营者应指派专人负责召回管理工作，并报告监管部门备案。
第七条召回计划的制定医疗器械生产、经营者应制定召回计划，并报告监管部门备案。
召回计划应包括召回范围、召回原因、召回措施、召回期限等内容。
第八条召回范围的确定医疗器械生产、经营者应确定召回的对象和范围，并及时通知召回对象及有关单位。
第九条召回措施的实施医疗器械生产、经营者应采取相应的措施，保证召回工作的顺利实施，包括但不限于下列方面：1. 召回通知的发布，向相关单位和个人发出召回通知；2. 召回产品的回收，确保召回产品的归集；3. 召回跟踪，及时了解召回产品的回收情况；4. 召回结果的报告，将召回结果报告给监管部门和相关单位。
医疗器械召回管理办法医疗器械召回管理办法第一章总则1.1 目的和依据医疗器械召回管理办法（以下简称“本办法”）的目的是为了规范和加强对医疗器械召回的管理，保障公众的安全和权益。
本办法依据《中华人民共和国医疗器械监督管理条例》等相关法律法规制定。
1.2 合用范围本办法合用于在中国境内生产、销售和使用的所有医疗器械召回活动。
第二章召回责任主体2.1 生产企业的责任生产企业应建立健全医疗器械召回制度，确保及时有效地开展召回活动。
生产企业应设立召回负责人，并明确其职责和权限。
2.2 分销企业的责任分销企业应配合生产企业的召回活动，协助生产企业进行召回通知、回收和销毁工作。
分销企业应建立召回记录，并按要求报送相关信息。
2.3 使用单位的责任使用单位应积极配合和支持召回工作，参预召回活动并按要求提供相关信息。
使用单位发现医疗器械存在安全风险应即将报告生产企业或者相关监管部门。
第三章召回程序3.1 召回计划制定生产企业应根据召回风险评估结果制定召回计划，并按要求申请召回编号。
3.2 召回公告发布生产企业应通过适当的方式发布召回公告，公告的内容应包括召回原因、召回范围、召回措施等信息，并明确召回要求和时间。
3.3 召回通知发送生产企业应向召回范围内的分销企业、使用单位和监管部门发送召回通知，通知中应包含召回计划、回收指南和连系方士等内容。
3.4 回收和销毁分销企业和使用单位应按要求回收医疗器械，并将回收的产品交给生产企业进行销毁，销毁过程应进行严格的记录和监管。
第四章召回监督与处罚4.1 监督检查监管部门有权对生产企业、分销企业和使用单位的召回工作进行监督检查，并提出整改要求。
4.2 处罚措施对违反召回管理规定的单位，监管部门有权采取行政处罚措施，包括警告、罚款、吊销许可证等。
附件：本所涉及的附件如下：1. 召回计划模板2. 召回公告发布渠道列表3. 召回通知模板...法律名词及注释：1. 《中华人民共和国医疗器械监督管理条例》：中华人民共和国国家立法机构发布的医疗器械监督管理的法规。
医疗器械召回管理办法第一章总则第一条：为加强医疗器械安全监管，保障人民群众的生命安全和身体健康，提高医疗器械的质量和技术水平，根据《中华人民共和国医疗器械监督管理条例》相关法规，在本办法中对医疗器械召回管理事项作出规定。
第二条：医疗器械召回是指制造商或经营者因发现其产品存在质量缺陷、存在安全隐患或未按照注册申报的规定生产、进口或经营，或其他原因需要限制使用、修改或召回的情况，采取专门行动，通知相关单位或个人停止使用、销售、处置或退还产品的活动。
第三条：医疗器械召回应当依法履行相应程序，惩戒违法行为，保护消费者合法权益。
第四条：医疗器械召回应当以事实为依据，以科学为基础，以合法监管为目标。
第五条：国家食品药品监督管理局负责全国范围内医疗器械召回的监督和管理。
第二章召回管理责任范围及义务第六条：医疗器械制造商应当建立健全医疗器械召回制度，明确召回工作的组织机构、责任人员及其职责，确保召回工作的有效性和及时性。
第七条：医疗器械制造商应当根据自身产品的特点和市场销售情况，对可能出现的质量问题和安全隐患进行评估和风险分析，并及时向国家食品药品监督管理局、省级药监部门报告相关信息。
第八条：医疗器械制造商应当建立健全产品批次追溯制度，确保召回工作的准确性和可追溯性。
第九条：医疗器械制造商应当及时停止生产、销售或进口存在质量缺陷、安全隐患的产品，并向国家食品药品监督管理局申请召回。
第十条：医疗器械制造商应当积极配合国家食品药品监督管理局的召回工作，提供相关信息和技术支持，协助督促经营者、使用者停止使用、销售或处置相关产品。
第十一条：医疗器械经营者应当建立健全医疗器械召回制度，明确召回工作的组织机构、责任人员及其职责，确保召回工作的有效性和及时性。
第十二条：医疗器械经营者应当定期与制造商沟通，了解产品质量和安全情况，及时向制造商反馈用户使用情况和可能存在的问题。
第十三条：医疗器械经营者应当及时停止销售存在质量缺陷、安全隐患的产品，并向国家食品药品监督管理局报告相关信息。
更改历史1.0目的为防止本公司出售的医疗器械不合格产品的使用或因其使用而造成对病人潜在的伤害或违背医疗器械规定要求，特制定本程序。
2.0范围适用于本公司生产的医疗器械产品售后才发现的不合格的忠告性通告或产品的召回。
3.0职责3.1总经理负责批准发布医疗器械不合格品的忠告性通知或产品的召回；3.2质管部负责编制医疗器械不合格品的忠告性通知或产品的召回通知；3.3质管部负责提供追溯产品的追溯性记录，以利于调查；3.4质管部负责对追溯程序的技术性判断；3.5经营部负责发布忠告性通知、产品的召回；3.6质管部对医疗器械不合格品的忠告性通知或产品的召回工作的检查；3.7在紧急情况下，当总经理不在公司时，且通讯无法联络时，应由本公司现场的最高领导批准发布医疗器械不合格品的忠告性通知或产品的召回;3.8管理者代表在当企业的生产条件不再符合医疗器械质量管理体系要求，可能影响医疗器械安全、有效时，应当立即向企业负责人报告，协助企业负责人及时开展停止生产活动、原因调查、产品召回等风险控制措施，并主动向所在地省、自治区、直辖市药品监督管理部门报告。
4.0工作程序4.1定义4.1.1忠告性通知：在医疗器械交付后，由生产企业发布的通知。
由生产企业发布的通知，旨在以下方面给出补充信息和/或建议采取的措施：（一）医疗器械的使用；（二）医疗器械的改动；（三）医疗器械返回生产组织，或（四）医疗器械的销毁4.1.2医疗器械召回：是指医疗器械生产企业按照规定的程序对其已上市销售的存在安全隐患的产品，采取警示、检查、修理、重新标签、修改说明书、软件升级、替换、收回、销毁等方式消除其产品危害的行为。
4.2忠告性通知的发布4.2.1医疗器械的任何事项的改变，经营部均应向顾客发布忠告性通知，例如：（一）产品结构和使用环境发生较大的改变时；（二）发现产品存在非预期的故障和事故隐患时；（三）产品发生质量事故，存在严重缺陷需要召回或销毁时；（四）存在设计缺陷的；（五）其他按法规要求需要发布忠告性通知的相关事件发生时；如因法规要求提高而达不到其要求时。
医疗器械召回管理办法引言医疗器械的召回是指制造或销售者主动采取措施，从市场中回收或改进医疗器械，以解决可能存在的安全风险和质量问题。
医疗器械召回管理办法的制定旨在保障患者和使用者的权益，确保医疗器械在市场上的安全和有效使用。
召回范围和条件召回范围医疗器械召回管理办法适用于所有在中国境内销售的医疗器械，不论其分类等级。
召回条件1. 发现医疗器械存在设计、制造或质量问题，可能对患者或使用者造成损害；2. 发现医疗器械已经在使用过程中出现质量问题，并可能导致损害；3. 发现医疗器械不符合国家监管要求。
召回程序和流程发现问题制造商或销售者在生产、销售、使用和维护过程中发现医疗器械存在问题或接收到相关投诉反馈时，应立即采取措施进行调查和评估。
决定召回经过调查和评估后，制造商或销售者应根据问题的严重性和影响范围，决定是否召回医疗器械，并向相关监管部门报告。
如果决定召回，应制定召回计划和方案。
实施召回制造商或销售者应通过公告、媒体宣传、寄发信函和方式联系等方式，向受影响的医疗机构、分销商和患者通知召回信息，并提供相应的处理措施和建议。
效果评估制造商或销售者应对召回行动的效果进行评估，确保所采取的措施能够解决问题和避免再次发生类似的事故。
监管和处罚相关监管部门将对医疗器械召回的过程进行监督，并根据召回行动的效果和制造商或销售者的处理情况，对违反管理办法的行为进行处罚。
召回记录和报告制造商或销售者应对医疗器械召回的过程和结果进行记录，包括召回通知的发布、受影响的单位和个人的情况，以及处理措施的实施情况。
召回记录应保存至少5年，并向相关监管部门报告。
结论医疗器械召回管理办法的制定和执行，对保障患者和使用者的权益，预防和解决医疗器械质量问题具有重要意义。
制造商和销售者应加强质量管理和监控，主动发现和解决问题，确保医疗器械在市场上的安全和有效使用。
监管部门应加强对召回过程的监管，加大违规行为的处罚力度，为患者和使用者提供更安全的医疗环境。
【分享】医疗器械⽣产质量管理规范（中英⽂对照版）国家⾷品药品监督管理总局关于发布医疗器械⽣产质量管理规范的公告（2014年第64号）CFDA Announcement on Releasing GoodManufacturing Practice for Medical Devices ([2014] No. 64)2014年12⽉29⽇发布Released on December 29, 2014国家⾷品药品监督管理总局China Food and Drug Administration公 告Announcement2014年 第64号[2014] No. 64关于发布医疗器械⽣产质量管理规范的公告Announcement on Releasing Good Manufacturing Practice for Medical Devices为加强医疗器械⽣产监督管理，规范医疗器械⽣产质量管理，根据《医疗器械监督管理条例》（国务院令第650号）、《医疗器械⽣产监督管理办法》（国家⾷品药品监督管理总局令第7号），国家⾷品药品监督管理总局组织修订了《医疗器械⽣产质量管理规范》，现予以发布。
In order to enhance the supervision and administration of, and standardize thequality management of, the medical devices manufacturing, and in accordancewith the Regulations for theSupervision and Administration of Medical Devices ( StateCouncil Order No. 650) and the Provisionfor Supervision of Medical DevicesManufacturing (CFDA Order No. 7), China Food and Drug Administration(“CFDA”) organized the revision of the GoodManufacturing Practice for Medical Devices, and which is hereby released.特此公告。
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:。
