医疗设备注册in Ireland

负责对爱尔兰医疗产品监管的国家监管机构机构是：

• Health Products Regulatory Authority(HPRA) (formerly the Irish Medicines Board).
• European Medicines Agency(EMA).
• 环保局（EPA）。

这HPRA(保健产品监管机构）是国家主管机构，负责：

• Regulation of medical devices and cosmetic products.
• 这authorisation of medicinal products.
• Monitoring of the quality, manufacturing, and distribution of medicinal products.
• Implementation of EU and national legislation relating to blood, blood components, tissues, and cells.
• 监视爱尔兰医疗设备的安全性后。
• 指定,不断监视性能nce of the Irish Notified Body which must have the capability to assess and approve specific medical devices.
• Operate a national reporting system for medical devices.
• Carry out on-site audits of selected manufacturers of medical devices to monitor compliance with relevant standards and legislation.

Combination products(Products that are therapeutic and diagnostic products that combine drugs, devices, and/or biological products) are regulated by the HPRA under medical devices legislation. These products are subject to high levels of compliance assessment and classified as class III (highest risk) devices.

所有源自生物技术和其他高科技过程的用于人类使用的药物都必须经过集中批准EMA。

这EPA是负责执行法规的主管权限，以实施在爱尔兰的含有或故意释放转基因生物（GMO）的权限。

医疗制定立法

这爱尔兰药品委员会(i.e IMB) is the competent authority for the regulation of medical devices on the Irish market, being the competent authority appointed under the Medical Devices Legislation. The IMB serves to ensure that all such devices which are placed on the market in Ireland meet the essential requirements of the Medical Devices Legislation.

立法中概述了三种类型的医疗设备。它们如下：

• General medical devices
• 主动植入医疗设备
• in-vitro diagnostic medical device.

医疗设备分为基于可能是低，中和高风险的风险的类。医疗设备调节的范围还包括体外诊断（IVD）医疗设备。IVD医疗设备包括任何医疗设备（例如试剂，试剂产品，校准器，控制材料，仪器，设备），该设备可单独使用或组合使用，并且该制造商打算在体外使用，以提供信息例如，生理或病理状态或监测治疗措施。其中包括妊娠试验试剂盒，尿液分析测试条和标本插座（例如血液收集管）。

Who needs to register?

If you have a registered place of business in the Republic of Ireland you must register with the HPRA if you:

• Manufacture class I or custom made medical devices and place them on the market under your own name, or trading name(s),
• Manufacture custom made active implantable medical devices and place them on the market under your own name, or trading name(s),
• Manufacture in-Vitro diagnostic medical devices and place them on the market under your own name, or trading name(s),
• Fully refurbish class I devices, or label one or more ready-made devices, with a view to placing these on the market under your own name,
• Place medical devices bearing the CE marking on the market, in a system or a procedure pack,
• 为了在市场，系统或程序包或其他CE标记的医疗设备上放置，由制造商设计在使用之前，
• Are the designated European authorized representative for a manufacturer who does not have a registered place of business in the European Community, and who places on the market devices within the above-listed categories

负责将医疗设备放置在爱尔兰市场的人员注册

Applicability Area:

1. If you have a registered place of business in Ireland you must register with the HPRA.
2. 如果您在会员国没有注册的营业地点，则必须指定欧盟中的单个授权代表代表制造商行事。

Application Procedure:

• 第一步：组织注册

• Second Step: Registration of Medical Device

• Third Step: Document review by HPRA

How can I register?

Step 1:组织注册

Mode of Registration is done in two ways:

Mode -1: Online Mode

Online registration with HPRA is to be done onwww.hpra.ie（对于医疗设备）需要费用。

Steps involved during the registration of the Organization:

Step 1: Organization Details

Step 2: Contact Details

步骤3：使用条件

OR

模式-2：手动模式

从“出版物和表单”部分下载的表格www.hpra.ie（对于医疗设备）应填充和附加支持文件，并提交给HPRA的必要费用。

(If registering as an authorized representative then attach the Notarized letter of a designation represents evidence of designation by the manufacturer)

Step 2:医疗设备的注册

Registration of the device is to be made online onhttps://access.medicaldevices.iewith the help of Username and Password issued by the HPRA, after the successful filling of device details, take the printout of it.

（注意：在医疗设备的注册期间，请为要注册的医疗设备提供全球医疗设备命名系统（GMDN）。如果GMDN不可用于特定设备，请与GMDN机构联系以获取命名。详细信息可以是在GMDN代理网站上看到）

该应用程序附带的文件：

1. 如果您是授权代表制造，则制造商的公证函
   application on behalf of a manufacturer
2. Documents required for review to the competent authority ( Class wise ):

• I类文档EC的合规性和技术文档声明（参考指令93/42/EEC：第11（5）条和附件VII第3部分S.I. 1994年第252页：第7条和附表7）
• Custom-made general medical device Documentation A statement and documentation allowing an understanding of the design (Reference Directive 93/42/EEC: Article 11(6) and Annex VIII S.I. No. 252 of 1994: Article 15 and Schedule 8 )
• System or Procedure Packs Documentation EC declaration of conformity and technical documentation (Reference Directive 93/42/EEC: Article 12 S.I. No. 252 of 1994: Article 11 )
• 定制的主动植入文档陈述和文档允许对设计了解（参考指令90/385/eec：第9（2）条和附件6 I. 1994年第254号：第（9）条1和时间表）

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