TheregulationofmedicaldevicesinAustralia澳大利亚市医疗器械监管
医疗器械分类规则 英文版
医疗器械分类规则英文版The Regulatory Framework for Medical Devices: Classification Criteria and ConsiderationsMedical devices play a crucial role in modern healthcare, providing vital tools and technologies to diagnose, treat, and monitor various health conditions. As the medical device industry continues to evolve, the need for robust regulatory frameworks to ensure the safety, efficacy, and quality of these products has become increasingly important. One of the fundamental aspects of medical device regulation is the classification system, which categorizes devices based on their intended use, level of risk, and other relevant factors.The classification of medical devices is a complex and multifaceted process that involves a thorough assessment of the device's characteristics and potential risks. The primary purpose of this classification system is to ensure that appropriate regulatory controls are in place to mitigate the risks associated with each device, thereby protecting patient safety and public health. By categorizing medical devices into different classes, regulatory authorities can tailor the review and approval process, as well as the ongoing monitoring and surveillance requirements, to match the level of risk presented by thedevice.In most regulatory jurisdictions, medical devices are generally classified into three or four main categories, with Class I representing the lowest-risk devices and Class III (or IV, in some cases) representing the highest-risk devices. The specific criteria and rules for device classification may vary across different regulatory frameworks, but the underlying principles and considerations are often similar.One of the key factors in the classification of medical devices is the intended use of the device. Devices that are intended for use in the diagnosis, treatment, or monitoring of a medical condition, or that are intended to modify the anatomy or a physiological process, are typically subject to a more stringent regulatory review than devices that are primarily intended for purposes such as patient comfort or convenience.Another important consideration in the classification process is the level of risk associated with the device. Devices that have a direct impact on the patient's health or that pose a higher risk of harm, such as those that are implanted or that are used in invasive procedures, are generally classified as higher-risk devices. Conversely, devices that have a lower risk profile, such as those used for routine diagnostic tests or that are external to the body, may be classified aslower-risk devices.In addition to the intended use and risk profile, the classification of medical devices may also take into account factors such as the device's level of technological complexity, the duration of use, and the degree of interaction with the human body. Devices that incorporate advanced technologies, have a prolonged period of use, or have a high level of interaction with the patient may be subject to more stringent regulatory requirements.The classification of medical devices is not a static process, as the landscape of medical technology is constantly evolving. Regulatory authorities must continually review and update their classification frameworks to address the emergence of new and innovative devices, as well as changes in the understanding of device-related risks. This dynamic nature of medical device regulation ensures that the classification system remains relevant and responsive to the needs of patients, healthcare providers, and the industry.In conclusion, the classification of medical devices is a critical aspect of the regulatory framework that ensures the safety, efficacy, and quality of these essential healthcare products. By categorizing devices based on their intended use, risk profile, and other relevant factors, regulatory authorities can tailor the review and approval process, as well as the ongoing monitoring and surveillancerequirements, to effectively manage the risks associated with each device. As the medical device industry continues to advance, the classification system must remain agile and adaptable, enabling the timely introduction of innovative technologies while maintaining the highest standards of patient safety and public health.。
2024年全国医疗设备管理新规定英文版
2024年全国医疗设备管理新规定英文版Title: New National Regulations for Medical Device Management in 2024In response to the growing need for effective medical device management, the government has introduced new regulations that will come into effect in 2024. These regulations aim to enhance the safety and quality of medical devices used across the country.One of the key changes outlined in the new regulations is the requirement for stricter quality control measures for medical devices. Manufacturers will need to adhere to higher standards to ensure that the devices meet safety and performance requirements. This will help prevent potential risks to patients and improve overall healthcare outcomes.Additionally, the regulations will introduce more comprehensive guidelines for the registration and approval process of medical devices.This will streamline the process and make it more efficient, ensuring that only safe and effective devices are allowed on the market.Furthermore, the new regulations will emphasize the importance of post-market surveillance and monitoring of medical devices. This will help identify any issues or safety concerns that may arise after the devices have been put into use, allowing for timely interventions and corrective actions.Overall, the new national regulations for medical device management in 2024 represent a significant step towards ensuring the safety, quality, and effectiveness of medical devices in the country. These regulations will benefit both healthcare providers and patients by improving the overall standards of care and reducing the risks associated with the use of medical devices.。
2024年医疗设备实验室管理条例英文版
2024年医疗设备实验室管理条例英文版2024 Medical Equipment Laboratory Management Regulations1. Purpose and ScopeThese regulations outline the management requirements for medical equipment laboratories in 2024.2. Definitions- Medical equipment: Devices used for medical purposes, including diagnostic, therapeutic, and monitoring equipment.- Laboratory: Facility where medical equipment is tested, calibrated, and maintained.3. LicensingAll medical equipment laboratories must obtain a license from the relevant regulatory authority to operate.4. Facility Requirements- Laboratories must be equipped with necessary tools and equipment for testing medical devices.- Adequate space and ventilation must be provided to ensure safety and accuracy in testing.5. Personnel- Qualified and trained personnel must be employed to conduct tests and maintain equipment.- Regular training and certification programs must be provided to ensure staff competency.6. Testing Procedures- Standardized testing procedures must be followed to ensure consistent and reliable results.- Testing protocols must be documented and easily accessible for reference.7. Quality Control- Laboratories must implement quality control measures to monitor the accuracy and reliability of testing.- Regular audits and inspections must be conducted to ensure compliance with regulations.8. Record Keeping- Detailed records of all testing activities, results, and equipment maintenance must be maintained.- Records must be kept confidential and stored in a secure manner.9. Reporting- Test results must be reported accurately and promptly to relevant stakeholders.- Any deviations or abnormalities in test results must be documented and reported to management.10. Compliance- Laboratories must comply with all applicable laws, regulations, and industry standards.- Non-compliance may result in fines, suspension of license, or other penalties.11. AmendmentsThese regulations may be amended as necessary to reflect changes in technology or industry best practices.12. EnforcementRegulatory authorities have the power to enforce these regulations and take appropriate action against non-compliant laboratories.13. Effective DateThese regulations will come into effect on January 1, 2024.14. ConclusionThe 2024 Medical Equipment Laboratory Management Regulations aim to ensure the quality and reliability of medical device testing through standardized practices and compliance with regulatory requirements.。
医疗器械召回管理办法(英文版)12
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, c ooperate 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 DevicesArticle 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 r egarding the defective events, and the administration departments c an 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 within7 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,s guide, update its software, fixing, relabeling, or amending the devices’ u ser’replacement or destruction, such measures a re 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 within10 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 investigationand 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 o f 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 t o 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, t he 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 a re 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 b y 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 of Device recalled incidentsProduct Name Registration Certificate No.ManufacturerChinese Responsible PartiesContact infoRecall events Contact infoUsage range of ProductRelated ProductsRegion and Countries involvedModal/SpecificationRelated ProductsQuantity of Sold Products Quantity (or imported)Identification Information(batch)Reason for recall(brief)Recall Action(brief)Report company：（stamp）Responsible person（Signature）Reporter:（Signature）Date of Report:Report of the Enforcement of recall scheduleProduct name Registration Certificate No.ManufacturerChinese Responsible Parties Contact infoRecall events Contact infoNConsignee Responsible forRecalled Products Number of people should be NotifiedO Number of already Notified T Time of NoticeF Means of NoticeCOther Consignee Number of people should be NotifiedA Number of already NotifiedT Time of NoticeION Means of NoticePerformanceQuantity to be RecalledCompleted QuantityEffectiveness inspectionprocessing methodEstimated Amount of TimeOthersReport company：（stamp）Responsible person（Signature）Reporter:（Signature）Date of Report:。
2024年医疗器械安全监管条例英文版
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.。
gbz医疗器械融入法规要求的指南
gbz医疗器械融入法规要求的指南英文回答：The integration of medical devices into regulatory requirements is essential to ensure their safety and efficacy in the market. This process involves adhering to guidelines and regulations set by governing bodies to ensure that the medical devices meet the necessary standards.One important guideline for medical device integration is the Good Manufacturing Practices (GMP) requirements. These requirements outline the necessary procedures and controls that manufacturers must follow during the production process. This includes aspects such as facility design, equipment validation, personnel training, and quality control measures. By adhering to GMP requirements, manufacturers can ensure that their medical devices are produced in a consistent and controlled manner, reducing the risk of defects or malfunctions.Another key guideline is the ISO 13485 standard, which focuses on the quality management system for medical devices. This standard sets out the requirements for the design, development, production, and distribution of medical devices. By complying with ISO 13485, manufacturers can demonstrate their commitment to quality and ensure that their devices meet the necessary regulatory requirements.In addition to these guidelines, medical device manufacturers must also comply with specific regulations set by regulatory bodies, such as the Food and Drug Administration (FDA) in the United States or the European Union's Medical Device Regulation (MDR). These regulations outline the necessary steps and documentation required for the approval and marketing of medical devices. This includes conducting clinical trials, obtaining necessary certifications, and maintaining post-market surveillance.Overall, the integration of medical devices into regulatory requirements is crucial to ensure their safety and effectiveness. By following guidelines such as GMPrequirements and ISO 13485, manufacturers can demonstrate their commitment to quality and compliance. Additionally, adhering to specific regulations set by governing bodies ensures that medical devices meet the necessary standardsfor approval and marketing.中文回答：将医疗器械融入法规要求是确保其在市场上的安全性和有效性的关键。
澳大利亚医疗器械监管概述
澳大利亚医疗器械监管概述1 澳大利亚的医疗器械管理机构澳政府于1990 年正式成立了治疗品管理局(TGA，Therapeutic Goods Administration)，管理药品、医疗器械以及其它治疗品，直属联邦卫生和老龄部(Commonwealth Department of Health and Ageing)。
TGA 通过开展一系列的评审和监督管理活动，确保澳大利亚可用的治疗品符合合适的标准，旨在保证澳大利亚社会的治疗水平在合理的时间内得到发展。
TGA 下设9 个部门，分别是事业管理组(Business Management Group)、行政支持组( Executive Support Uni t)、辅助药品办公室(Office of Complementary Medicines)、器械、血液和组织办公室(Office of Devices, Blood and Tissues)、实验室和科学服务办公室(Offce of Laboratories and Scientifc Services)、制造质量办公室(Offce of Manufacturing Quality)、药品安全监管办公室(Offce of Medicines Safety Monitoring)、非处方药办公室(Offce of Non Prescription Medicines)和处方药办公室(Offce of Prescription Medicines)。
由器械、血液和人体组织办公室(ODBT) 通过上市前评价，发放生产许可证和上市后警戒控制医疗器械的管理。
2 法律法规澳大利亚早在1966年就开始使用《医疗用品法案1966))对医疗用品(包括化学药品、生物制品、医疗器械、草药制品、维生素及矿物质)进行管理。
《医疗用品法案1989)>是目前对医疗用品进行管理的主要法案，目的是为规定如何保证澳大利亚医疗用品的质量、安全性及有效性提供一整套全国性的方案。
英国医疗器械法规
英国医疗器械法规（实用版）目录1.英国医疗器械法规简介2.英国医疗器械法规的分类3.英国医疗器械法规的执行机构4.英国医疗器械法规的法规要求5.英国医疗器械法规的合规方式6.英国医疗器械法规的违规处罚7.我国医疗器械企业在英国市场的应对策略正文【英国医疗器械法规简介】英国医疗器械法规是指在英国境内生产、销售和使用的医疗器械所需遵守的相关法律法规。
这些法规旨在确保医疗器械的安全性、有效性和质量，以保护公众的健康和安全。
【英国医疗器械法规的分类】英国医疗器械法规主要分为以下几类：1.欧盟指令：英国作为欧盟成员国，需遵守欧盟有关医疗器械的指令，如欧盟医疗器械指令（MDD）和欧盟主动植入式医疗器械指令（AIMDD）等。
2.英国法规：英国政府根据欧盟指令制定了一系列国内法规，如《医疗器械法规》（The Medical Devices Regulations，简称 MDR）和《主动植入式医疗器械法规》（The In-vitro Diagnostic Medical Device Regulations，简称 IVDR）等。
3.标准和指南：英国标准协会（BSI）等机构发布了一系列医疗器械相关的标准和指南，如 BS EN ISO 13485《医疗器械 - 质量管理体系 - 要求和指南》等。
【英国医疗器械法规的执行机构】英国医疗器械法规的执行机构主要包括：1.英国药品和保健产品监管局（MHRA）：负责医疗器械的监管，包括产品注册、上市后监管、合规检查等。
2.英国标准协会（BSI）：负责医疗器械标准的制定和推广。
3.英国国家医疗服务体系（NHS）：负责医疗器械在国家医疗服务体系中的采购和使用。
【英国医疗器械法规的法规要求】英国医疗器械法规对医疗器械的生产、销售、使用等方面提出了一系列要求，包括：1.注册：大部分医疗器械需要在 MHRA 进行注册，部分高风险医疗器械还需通过认证机构的认证。
2.合规评估：医疗器械企业需进行合规评估，确保产品符合法规要求。
欧盟mdcg医疗器械法规中英文对照
欧盟mdcg医疗器械法规中英文对照EU MDR/IVDR Regulations - Key Changes and Impacts on Medical Device ManufacturersIntroduction:The European Union's Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) represent a major overhaul of the regulatory framework for medical devices in Europe. These new regulations aim to strengthen patient safety, ensure transparency and improve the performance of medical devices in the EU market. Understanding the key changes and impacts of these regulations is crucial for medical device manufacturers looking to market their products in the EU.Key Changes in the EU MDR/IVDR:1. Classification: The MDR/IVDR introduces new classification rules for medical devices based on risk, taking into account new technology and scientific advancements. Manufacturers will need to reclassify their devices under the new rules to ensure compliance.2. Notified Bodies: The MDR/IVDR establishes stricter requirements for Notified Bodies, including increased competence and resource requirements. Manufacturers willneed to work with designated Notified Bodies for conformity assessment and certification.3. Unique Device Identification (UDI): The MDR/IVDR requires all medical devices to carry a unique device identifier (UDI) for traceability and post-market surveillance purposes. Manufacturers will need to implement UDI systems and comply with the labeling requirements.4. Clinical Evidence: The MDR/IVDR introduces new requirements for clinical evaluation, including a more robust process for demonstrating safety and performance based on clinical data. Manufacturers will need to ensure their devices meet the new clinical evidence requirements.5. Post-Market Surveillance: The MDR/IVDR places greater emphasis on post-market surveillance and vigilance, requiring manufacturers to actively monitor the safety and performance of their devices throughout their lifecycle. Manufacturers will need to establish and maintain post-market surveillance systems.Impacts on Medical Device Manufacturers:1. Compliance Costs: The implementation of the MDR/IVDR will require significant investment in resources, expertise, andinfrastructure to ensure compliance with the new regulations. Manufacturers will need to budget for these additional costs.2. Market Access: The MDR/IVDR will impact market access for medical devices in the EU, as manufacturers will need to demonstrate compliance with the new regulations to obtain CE marking and market their products. Non-compliance could result in market withdrawal.3. Time to Market: The MDR/IVDR introduces new requirements for conformity assessment and certification, which could lead to delays in getting products to market. Manufacturers will need to factor in additional time for compliance with the new regulations.4. Competitiveness: Manufacturers that proactively adapt to the new regulatory requirements of the MDR/IVDR will have a competitive advantage in the EU market. Those that fail to comply could risk losing market share to competitors.Conclusion:The EU MDR/IVDR regulations represent a significant shift in the regulatory landscape for medical devices in Europe. Understanding the key changes and impacts of these regulations is essential for medical device manufacturers looking to navigatethe new regulatory environment. By proactively adapting to the new requirements, manufacturers can ensure compliance, maintain market access, and stay competitive in the EU market.。
医疗器械进入澳大利亚和新西兰医疗器械市场要求
入澳大利亚和新西兰的相关知识一、澳大利亚认证介绍1、治疗商品管理局（TGA）是澳大利亚政府健康和养老部门的一个机构。
主要的治疗商品必须在进入澳大利亚市场之前进入澳大利亚治疗商品注册名单（ARTG）。
ARTG是在澳大利亚使用的或从澳大利亚出口的关于人用的治疗商品的信息数据库。
（TGA认证）（1）治疗用途是指：•防护、诊断、养护或缓和病痛、疾病、残疾或受伤；•影响、抑制或者改变某个生理过程；•检测人体对某个疾病的感受性；•影响、控制或抑制受孕；•检测怀孕；•改变或修改解剖的某个部分。
（2）对治疗商品供应的控制主要通过三方面的途径：•生产厂商品质的审核与评审；•商品的入市前评审；•商品入市后对标准的符合性监控。
（3）对医疗器械的规范包括如下几个部分：•医疗器械基于不同风险等级的分类；•对其品质、安全和性能的一系列基本要求得符合性评价；•对医疗器械生产过程的相应法令控制；•在ARTG中包含该医疗器械；•包含某个广泛警告系统和事故报告机制。
1、澳大利亚认证为SAA认证，SAA是一个独立的公司，与政府没有直接的关系，尽管联邦政府和州政府是它其中的成员。
然而，由于在任何一个国家的技术基础设施中的重要性意味着同政府的密切合作和是非常必要的2、SAA和联邦政府之间有一个理解备忘录承认SAA是澳大利亚的非政府标准机构的最高组织。
在备忘录中指出，标准的制定要与WTO的要求一致，为此，有协议指出当合适的国际标准已存在时，就不用制定新的澳大利亚标准。
3、澳大利亚是联邦国家，电器安全及能耗要求的认证、控制和管理工作由各个州或地区的监控部门（Regulatory Authority）按照本州/地区的认证程序进行，各州及地区的相关部门清单请间表1。
任何一个州颁发的证书在其他州/地区同样有效，不许任何附加手续，这已经由立法的形式规定下来，此外，SAA标准制定机构的全资子公司QAS（Quality Assurance Services Pty Ltd.）是澳大利亚的NCB(National Certification Body)，其出具的证书也到了各个州或地区的承认，有同等的效力。
如何在澳大利亚注册医疗器械
符合性声明（DoC）
一旦制造商已取得合格评定证据，必须做一份澳大利亚符合性声明（DoC） 符合性声明（DoC）宣布该设备符合以下标准：
澳大利亚与以下国家已有其他协定： · 新西兰：澳大利亚和新西兰政府签署了一项协议，建立一个联合医疗产品的 规管制度，这一项协议目前被搁置。 · 加拿大：关于质量管理体系证书的认可备忘录已签署 · 瑞士：以便交流治疗产品有关的规管决定和市场售后监测信息备忘录已签署 · 新加坡：合格评定认证相互承认协议。
如何使用器械电子申请递交系统注册一个医疗器械？
为了注册的医疗器械，您需要建立一个器械电子申请递交系统的电子商业帐户 。器械电子申请递交系统的新用户首先需要建立一个TGA电子商业帐户。这在 https：/ / .au点击电子商贸表部分然后下载表格：
· 客户资料表格 - 如果作为一个赞助商，你没有客户标识号，只需完成这一表 格。赞助商首次必须为赞助商和海外制造商完成这一表格。
用品管理局主要负责监管这个行业。
1989年治疗物品法令医疗器械官方定义为： “任何仪器，设备，器具，材料或者其他物品（无论是单独使用或合用，并包括其 需要的软件），由经销人在他名下提供的，拟用于人体一个或多个以下的目的：
§ 诊断，预防，监测，治疗或减轻疾病， § 诊断，监测，治疗，对损伤的减轻或对残疾的补偿， § 调查，更换或更改解剖或生理过程， § 避孕设施， 或通过药理学，免疫学或者代谢的手段，对人体没有实现其主要的预定目的，但可 能通过这些手段达到辅助作用; 或是以上的仪器，设备，器具，材料或者其他物品 的配件。或 aa）在2A项下的任何仪器，设备，器具，材料或者其他物品, 或 ab）是包含在2B项下的仪器，设备，器具，材料或其他物品种类中的任何仪器，设 备，器具，材料或者其他物品，或 b）以上仪器，设备，器具，材料或其他物品覆盖（a），（aa）或（ab）的一个附 件。
医疗器械注册管理办法(中英文)翻译
医疗器械注册管理办法Medical Devices Registration Administration Method总则Chapter 1 General Provisions第一条为规范医疗器械的注册管理，保证医疗器械的安全、有效，根据《医疗器械监督管理条例》，制定本办法.Article 1 To regulate medical device registration management and ensure their safety and effectiveness of medical device, we set down the management measure according to Regulations for the Supervision and Administration of Medical Device。
第二条在中华人民共和国境内销售、使用的医疗器械均应当按照本办法的规定申请注册，未获准注册的医疗器械，不得销售、使用。
Article 2 All the medical device which would like to sell and use within the territory of the People’s Republic of China shall apply for registration complying with this measure。
These medical devices which not get China registration approval should be prohibited to sell and use。
第三条医疗器械注册，是指依照法定程序，对拟上市销售、使用的医疗器械的安全性、有效性进行系统评价,以决定是否同意其销售、使用的过程。
Article 3 Medical device registration is the process of doing systemic evaluation of plan—market medical device on their safety and effectiveness，then decide if medical device can be allowed to sell and use.第四条国家对医疗器械实行分类注册管理。
中文版Medical Devices Regulations SOR98-282
医疗器械监督管理条例（Medical Devices Regulations）SOR/98-282食品和药品法总督会同行政局在卫生部长的建议，根据第3（3），30（1）及37（1）一个食品和药品法，特此所附的医疗器械监督管理条例。
一个资深大律师 1993年，。
34，。
73注册1998年5月7日医疗器械法规释义（1）本节中的定义适用于本条例。
“法”是指食品和药品法“。
（LOI）“有源器件”指的是医疗装置，其由人体或重力产生的能量以外的能量的源操作取决于。
发送或提取能量或物质没有大幅改变的能量或物质或从病人的医疗设备，是不是有源器件。
（ACTIF仪器）“积极的诊断装置”是指一个有源器件，无论是单独使用或与其他医疗装置的组合，目的是提供信息的目的的检测，监测或治疗的生理条件下，健康，疾病或先天性畸形的状态。
（ACTIF仪器diagnostique）“活性治疗装置”是指一个有源器件，无论是单独使用或与其他医疗装置的组合，目的是支持，修改，替换或恢复的生物学功能或结构的目的，治疗或缓解疾病或损伤或生病或受伤的症状。
（ACTIF仪器thérapeutique）“条形码”是指一个独特的条形码符号的通用产品代码（UPC），健康产业商业通信委员会（HIBCC）或欧洲商品编码（EAN），分配到一家医疗设备制造商。
（代码A巴雷斯）“人体孔口”指自然开口或在体内，如气孔永久人造开口。
（孔杜队）“中央心血管系统”是指心脏，心包，肺静脉，肺动脉，心静脉，冠状动脉，颈总动脉，脑动脉，头臂动脉，主动脉，下腔静脉，肾动脉，髂动脉和股动脉。
（SYSTEME cardiovasculaire中央）“中枢神经系统”是指脑，脑膜，脊髓和脑脊液。
（SYSTEME nerveux中央）“闭环系统”，在医疗设备方面，是指一个系统，使设备的感知，解释和治疗的医疗条件，无需人工干预。
（SYSTEME 单布克勒fermée的）“专利专员”，是指根据“专利法”第4（1）委任的专利专员。
澳大利亚扩大医疗器械申请中可接受外国监管机构的范围
澳大利亚扩大医疗器械申请中可接受外国监管机构的范围2018年8月21日Ana Mulero从本月起，澳大利亚治疗用品管理局（TGA）将扩大其在医疗器械申请方面可接受的国际评估和批准的范围。
本周一，TGA表示，具有可比性的国外监管机构（COR）的数量将不再只包括欧盟公告机构，也将会包括美国食品药品监督管理局（FDA），加拿大卫生部，受医疗器械单一审核程序管辖的审计机构，以及日本厚生省及其药品医疗器械机构。
这一决定是TGA对澳大利亚政府之前基于对其药品和医疗器械管理条例的评估，要求加强对某些国外市场批准上市的医疗器械的使用所提出的建议而做出的回应。
作为该决定的一部分，TGA本周一发布了新的指导原则，以帮助适用的企业缩小此前已获得的海外评估和批准和纳入澳大利亚治疗用品注册（ARTG）之前的差距。
指导原则中明确了TGA接纳国外文件，包括FDA的决定和加拿大卫生部的批准和许可，作为其自身评估的证据的要求。
例如，提交的文件应是关于同一器械且为相同的预期目的和适应症所设计。
该监管机构表示:“这将使TGA减少必须按照特殊申请来进行的评估数量。
”此前，该监管机构已经在6月份的时候，在药品申请的工作分工上，执行了一种新的COR 程序。
英文原文Australia Expands Range of Acceptable Foreign Regulators for Device ApplicationsPosted 21 August 2018 | By Ana MuleroBeginning this month, Australia’s Therapeutic Goods Administration (TGA) will expand its range of acceptable international assessments and approvals on medical device applications.TGA said Monday the number of comparable overseas regulators (COR) will start to include not just EU notified bodies, but also the US Food and Drug Administration (FDA), Health Canada, auditing organizations under the Medical Device Single Audit Program, as well as Japan’s Ministry of Health, Labour and Welfare and its Pharmaceutical and Medical Devices Agency.The decision comes as TGA’s response to a previous recommendation from the Australian government, which was based on its review of the medicines and medical devices regulation, for the regulator to enhance its use of certain marketing approvals for devices in foreign markets.As part of the decision, TGA released new guidance on Monday to aid industry in bridging the gap between previously obtained overseas assessments and approvals and the inclusion of medical devices in the Australian Register of Therapeutic Goods (ARTG) as applicable.The guidance document sets forth the requirements for TGA to take into consideration overseas documentation, including on FDA decisions and Health Canada approvals and licenses, as evidence for its own assessments. For example, the proposed documentation should be on the same device and design for the same intended purpose and indications.“This will result in the TGA being able to reduce the amount of assessment that it must undertake on a particular app lication,” the regulator said.The regulator implemented a new COR process for work-sharing on drug applications in June.A separate notice posted by TGA on Monday provides additional guidance on applications requirements for medical devices to pass preliminary assessments for inclusion in the ARTG.内容来自：Regulatory Affairs Professionals Society (RAPS)。
澳大利亚医疗器械法规概述
THANKS.
IIb类和III类医疗器械
03
高风险，管理要求最为严格，需要进行全面的注册和许可程序
，包括临床试验、质量管理体系审核等。
医疗器械的注册和许可程序
申请途径
申请材料
制造商或授权代表可通过澳大利亚医疗用 品管理局（TGA）的在线系统提交注册或许 可申请。
申请时需提交包括产品技术文档、质量管 理体系文件、临床评价报告等在内的相关 材料。
的医疗器械符合相关的安全和性能标准，以保障公众的健康和安全。
02 03
促进医疗器械行业的创新和发展
通过制定和实施科学合理的法规，澳大利亚政府旨在推动医疗器械行业 的创新和发展，鼓励企业研发和生产更高质量、更先进的医疗器械产品 。
与国际标准和最佳实践保持一致
澳大利亚医疗器械法规积极借鉴和采用国际标准和最佳实践，以促进国 际贸易合作和技术交流，提高澳大利亚医疗器械行业的国际竞争力。
性。
生产企业应对质量管理体系进行 定期的内部审核和外部审核，确 保质量管理体系的有效性和持续
改进。
医疗器械的市场准
05
入与监管
市场准入的要求和程序
01
02
03
04
申请医疗器械市场准入前，制 造商需确保产品符合澳大利亚 医疗器械法规和标准的要求。
根据风险等级，医疗器械被分 为不同类别，各类别的市场准
澳大利亚竞争与消费者委员会（Australian Competition and Consumer Commission，ACCC）：ACCC负责监管医 疗器械的市场行为，包括虚假宣传、价格欺诈等不正当竞争 行为。
相关法规和标准
欧盟医疗器械指令（European Medical Devices Directives）：虽然澳 大利亚不是欧盟成员国，但其医疗器械法规在很大程度上参考了欧盟的 医疗器械指令，包括医疗器械的分类、技术文件要求等。
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Tens of thousands of hip and knee procedures are performed every year. Ongoing safety and
performance monitoring is important to ensure public safety after the device is made
44534 46793 48431 39405 40976 33127 34064 36050 25539 28322 30194
2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Hip procedures performed 2002 - 2012
alleviation of disease, injury or disability • investigation, replacement or modification of the
anatomy or of a physiological process • control of conception
Glucose meter
no public health risk or low personal risk
Class 2 IVD or Class 2 in-house IVD: low public health risk or moderate personal risk
Pregnancy and fertility self-testing kits
45000 40000 35000 30000 25000
32964 34373 36021 37620 37918 24499 26605 28206 29204 29843 30690
20000
15000
10000
5000
0 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
real life use
6
Benefit versus risk approach
The level of regulation is based on consideration of:
Risk to patients, users and other
persons (probability and severity of harm)
3
What is a medical device?
The TGA defines a medical device as an instrument apparatus, appliance, material or other article intended to be used for human beings for: • diagnosis, prevention, monitoring, treatment or
பைடு நூலகம்
available on the market.
55
How does a medical device get to market?
A sponsor makes an application to include a device on the Australian Register of Therapeutic Goods (ARTG) so that it can be legally supplied in Australia
See the following slide for an example
11
Assessing benefits versus known side effects
Left ventricular assist device
Complex medical devices used to assist with the ventricular flow of blood to the body in patients with significant heart failure
General principles
• Use of medical devices not to compromise health and safety • Design and construction of medical devices to conform to safety
principles • Medical devices to be suitable for intended purpose • Long-term safety • Medical devices not to be adversely affected by transport or storage • Benefits of medical devices to outweigh any side effects
The applicant must have information available to demonstrate the quality, safety and performance of the medical device
The device must undergo a Conformity Assessment* procedure and comply with the Essential Principles*.
Information on their performance and safety is important prior to market authorisation
Most new devices are
improvements of older
versions based on
data collected from
medical devices • How does a medical device get to
market? • The benefit versus risk approach
• Risk classification rules • In vitro diagnostic tests • Essential principles • Conformity assessment • Safety and performance • Other education modules
• Blood bags • Biological heart valves • Implantable pacemakers
8
In vitro diagnostic tests
In vitro diagnostics have been regulated since July 2010 – with a four year transition period. By the end of the transition period (2014) all IVDs will be regulated to protect public and personal health
2
Comparing medicines and medical devices
A medical device does not achieve its principal intended action by pharmacological,
immunological or metabolic means like a medicine or vaccine
Class 4 IVD or Class 4 in-house IVD: high public health risk
All tests used by the Australian Red Cross Blood Service for the testing of blood
10
Essential principles that govern devices
Class 3 IVD or Class 3 in-house IVD: moderate public health risk or high personal risk
Viral load and genotyping assays for HIV and Hepatitis C
Higher risk
Degree of invasiveness in the human body
Intended use of the device
Risk classification is based on:
Duration of use
A device may be selected for review by the TGA once it is on the market. More information and case studies are in the educational module on postmarket monitoring. 7 7
Bandages
Dental implant Breast implant Glucose monitor
4
Many patients require medical devices
60000 50000 40000 30000 20000 10000
0
Knee procedures performed 2002 - 2012
Risk classification rules – medical devices
Lower Medical device classification risk
Example
• Class I
• Class Is (intended to be supplied sterile)