英国医疗器材登记法规问题集

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时间：2023/09/08  drafted by Yvonne Chen

各国医疗器材登记法规问答集

HLF-TW-10
请问英国对于医疗器材的归类方式为何？它的正式名称为何？不同归类管理强度有何差异?它的政府管辖机构为何？网页？

What are the categories of medical devices in The United Kingdom? What is its official name? What is the intensity of management of different categories? What is the governmental authority of medical devices? Website?
Evershine RD：
在英国，医疗器材由药品和保健品监管局 ( MHRA ) 负责监管。
医疗器材的定义是：製造的目的在提供人类医疗目的上的任何装置、器具、软体、材料或其他物品，无论是单独使用还是组合使用。医疗器材包括体外诊断医疗器材，也包括植入患者体内并需要外部电源的有源植入式医疗器材。

一、医疗器材等级：(依对人体的风险程度)
1.Ⅰ类：轮椅、眼镜、听诊器、压舌板等。
2.IIa类：牙科填充物、手术夹、气管切开插管等。
3.IIb类：避孕套、肺部呼吸机、骨固定板等。
4.III类：心脏起搏器、心脏瓣膜、植入式脑刺激器等。

二、医疗器材分类：

1. 非侵入性：不进入人体的设备，例如膏药、手杖、轮椅、人工肾(体外透析)等。
2. 侵入性：插入身体孔道的装置，例如隐形眼镜、灌肠剂、检查手套等。
3. 手术侵入性：手术中使用或插入的装置，例如针、手术刀、心血管导管等。
4. 主动式：需要外部电源的设备，例如X射线、超声波、TENS等。
5. 植入式：植入体内的设备，例如乳房植入物、骨科植入物、人工晶状体等。

In the UK, medical devices are regulated by the Medicines and Healthcare products Regulatory Agency (MHRA).
A medical device is defined as any device, appliance, software, material or other article manufactured for the purpose of providing medical treatment to humans, whether used alone or in combination. Medical devices include in vitro diagnostic medical devices and active implantable medical devices that are implanted in the patient’s body and require an external power source.

1. Medical device grade: (depending on the risk to the human body)
2. Class I: wheelchairs, glasses, stethoscopes, tongue depressors, etc.
3. Class IIa: dental fillings, surgical clips, tracheotomy tubes, etc.
4. Class IIb: condoms, lung ventilators, bone fixation plates, etc.
5. Class III: pacemakers, heart valves, implantable brain stimulators, etc.
6. Classification of medical device:
7. Non-invasive: device that does not enter the human body, such as plasters, canes, wheelchairs, artificial kidneys (extracorporeal dialysis), etc.
8. Invasive: Devices inserted into body orifices, such as contact lenses, enemas, examination gloves, etc.
9. Surgical invasiveness: devices used or inserted during surgery, such as needles, scalpels, cardiovascular catheters, etc.
10. Active: device that requires external power supply, such as X-ray, ultrasound, TENS, etc.
11. Implantable: Devices implanted in the body, such as breast implants, orthopedic implants, intraocular lenses, etc.

【参考连结】
https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk
https://www.gov.uk/government/publications/medicines-and-medical-devices-bill-overarching-documents/factsheet-medical-devices-overview#what-a-medical-device-is

HLF-TW-20
外国公司要到英国销售医疗器材，无论设100%子公司或分公司，需要在公司登记时取得营业特许证？假如要，其必要条件是什麽？所需文件及申请程序为何？网页？

If a foreign company wants to sell medical devices in The United Kingdom, no matter if it sets up a 100% subsidiary or branch, does it need to obtain an approval from local health bureau before the company’s registration? If so, what are the requests? What are the required documents and application procedures? Website?
Evershine RD：
无营业特许证。
No business license.

【参考连结】
https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market

HLF-TW-25

HLF-TW-30
外国公司要到英国销售医疗器材，可以指派英国公司担任营业代理人销售吗? 担任营业代理人，其必要条件是什麽？所需文件及申请程序为何？外国公司与营业代理人的产品责任为何?网页？

If a foreign company wants to sell medical devices in The United Kingdom, can it assign a The United Kingdom company to act as a business agent? What are the requests for acting as a business agent? What are the required documents and application procedures? What is the product liability of foreign companies and the business agents? Website?
Evershine RD：
可以，医疗器材法规没有特别规范营业代理人条件。

产品安全
产品的责任由製造商及英国负责人为首要。製造商需要承担放置或供应到英国市场的医疗器材发生不良事件而产生的任何法律责任；英国负责人代表非英国製造商执行与製造商义务相关的责任，但是进口、分销或销售医疗器材的企业都要对安全负责并配合改善措施。

Yes, the medical device regulations do not specifically regulate the conditions for business agents.

Product Safety
Responsibility for the product rests with the manufacturer and the UK responsible person first. Manufacturers need to bear any legal liability arising from adverse events in medical devices placed or supplied to the UK market; UK responsible persons carry out responsibilities related to manufacturer obligations on behalf of non-UK manufacturers, but companies that import, distribute or sell medical devices Everyone must be responsible for safety and cooperate with improvement measures.

【参考连结】
https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market
https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk#post-market-surveillance-and-vigilance

HLF-TW-35

HLF-TW-40
外国公司销售到英国医疗器材本身，进口前需要办理产品许可吗？如需要，哪个单位在管理？需要什麽文件？申请程序为何？医疗器材包装内容及各种标识，需要事先核准吗？可允许的语文有哪些？网页？

Do foreign companies need to apply for an approval before importing medical devices sold to The United Kingdom? If yes, which authority is in charge? What documents are required? What is the application process? Do medical devices packaging and labeling require prior approval? Which languages are allowed? Website?
Evershine RD：
需要，需完成医疗器材产品註册。
在英国上市的所有医疗器材，包括体外诊断医疗器材、订製器材和系统或软体程式，都必须在 MHRA 註册，才能投放到英国市场。
一、申请资格：
1.製造商需要进行产品註册，如果製造商位于英国境外，就必须任命一名英国负责人来负责其所有医疗器材。英国负责人必须提供书面的授权证明。

2.进口商或分销商可以同时担任英国负责人。

二、申请网址：
https://mhrabpm.appiancloud.com/suite/plugins/servlet/registration

三、基本资料：
1.製造商详细资讯
．设备标籤/包装上的法人实体名称和地址
．公司类型，例如有限公司、个体工商
．管理联繫人（最多可以有 15 名人员权限）。
．英国负责人的合法授权书（如适用），声明代表製造商行事的唯一英国负责人，并代表製造商承担的强制性任务
2.设备详细资讯
．设备类别
．UDI-DI（如果适用）
．医疗器材名称（品牌/商品/专有名称）
．型号或版本
．目录/参考号
．英国认可机构（或欧盟公告机构）（如适用）
．无菌、含有乳胶、MRI等属性
．合格评定证书或自我认证合格声明的副本（如果适用）
四、费用：每份註册需缴纳 240 英镑的法定费用。
五、有效期：首次申请日期为 MHRA 完成帐户后 1 年，之后至少每 2 年要续订一次。

标籤
1.製造商的名称或商号和地址(如果製造商没有註册地点，应包含英国负责人的姓名和地址)
2.无菌的标识(如适用)
3.批次代码(LOT) 或序列号
4.以年和月表示安全使用期
5.一次性使用的标识(如适用)
6.订製设备的标识(如适用)
7.专门用于临床研究的标识(如适用)
8.任何特殊的储存和/或处理条件
9.任何特殊操作说明
10.任何警告和/或採取的预防措施
11.灭菌方法(如适用)
12.含有人类血液衍生物的标识(如适用)
13.如果设备的预期用途对用户来说不明显，製造商必须在标籤和使用说明中明确说明
14.性能和任何不良的副作用
15.如果该器材必须与其他医疗器材或设备一起安装或连接，则应提供其特性的足够详细资讯
16.维护和校正的方式和频率
17.无菌包装损坏时重新灭菌方法
18.如果器材是可重複使用的，有关重複使用的流程，包括清洁、消毒、包装，以及重新灭菌的器材的灭菌方法和重複使用次数的任何限制
19.辐射的性质、类型、强度和分佈的详细资讯(如适用)
20.禁忌症和应採取的预防措施的详细资讯
21.暴露于磁场、外部电影响、静电放电、压力或压力变化、加速度、热点火源等时应採取的预防措施
22.使用说明的发布日期或最新版本
23.标籤应以英语表示。

Yes, medical device product registration needs to be completed.
All medical devices marketed in the UK, including IVDs, custom-made devices and systems or software programs, must be registered with the MHRA before they can be placed on the UK market.

1. Application qualifications:
2. The manufacturer needs to register the product. If the manufacturer is located outside the UK, it must appoint a UK responsible person to be responsible for all its medical equipment. The UK responsible person must provide written proof of authorization.
3. The importer or distributor can act as the UK responsible person at the same time.
4. UR : https://mhrabpm.appiancloud.com/suite/plugins/servlet/registration
5. Basic information:
6. Manufacturer details
   ． Legal entity name and address on device label/packaging
   ． Company type, such as limited company, sole proprietorship
   ． Manage contacts (up to 15 people permissions).
   ． Legal power of attorney from the UK Responsible Person (if applicable) stating the sole UK Responsible Person acting on behalf of the manufacturer and the mandatory tasks undertaken on behalf of the manufacturer
7. Device details
   ．Device category
   ．UDI-DI (if applicable)
   ．Medical Device Name (Brand/Commodity/Proprietary Name)
   ．Model or version
   ．Catalog/reference number
   ．UK Accreditation Body (or EU Notified Body) (if applicable)
   ．Sterile, latex-containing, MRI and other properties
   ．Copy of conformity assessment certificate or self-certification declaration of conformity (if applicable)
8. Fees: There is a statutory fee of £240 for each registration.
9. Validity period: The first application date is 1 year after the MHRA completes the account, and it must be renewed at least every 2 years thereafter.

Label

1. The name or trade name and address of the manufacturer (if the manufacturer has no place of registration, the name and address of the responsible person in the UK should be included)
2. Sterility identification (if applicable)
3. Lot code (LOT) or serial number
4. Indicate the safe use period in years and months
5. Single-use identification (if applicable)
6. Identification of customized device (if applicable)
7. Identification specifically used for clinical research (if applicable)
8. Any special storage and/or handling conditions
9. Any special operating instructions
10. Any warnings and/or precautions to be taken
11. Sterilization method (if applicable)
12. Identification of products containing human blood derivatives (if applicable)
13. If the intended use of the device is not obvious to the user, the manufacturer must clearly state this on the label and instructions for use
14. Performance and any adverse side effects
15. If the device must be installed or connected with other medical devices or device, sufficient details of its characteristics should be provided
16. Method and frequency of maintenance and correction
17. Re-sterilization method when the sterile packaging is damaged
18. If the device is reusable, any restrictions on the reuse process, including cleaning, disinfection, packaging, and sterilization methods and number of reuses for the device that are re-sterilized
19. Detailed information on the nature, type, intensity and distribution of radiation (if applicable)
20. Detailed information on contraindications and precautions to be taken
21. Precautions to be taken when exposed to magnetic fields, external electrical influences, electrostatic discharges, pressure or changes in pressure, acceleration, hot ignition sources, etc.
22. Date of issue or latest version of the instructions for use
23. Labels should be in English.

【参考连结】
https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market
https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk#responsible
https://www.legislation.gov.uk/uksi/2002/618/contents/made

HLF-TW-45

HLF-TW-50
外国公司可以用自己名义申请办理产品许可吗？如需要，哪个单位在管理？需要什麽文件？申请程序为何？医疗器材包装内容及各种标识，需要事先核准吗？可允许的语文有哪些？？网页？

Can a foreign company apply for a product license by its own name? If yes, which authority is in charge? What documents are required? What is the application process? Do medical devices packaging and labeling require prior approval? Which languages are allowed?? Website?
Evershine RD：
不行，需由製造商或其授权英国负责人进行产品註册人，进口商可以做为同时担任英国负责人。

在英国上市的所有医疗器材，包括体外诊断医疗器材、订製器材和系统或软体程式，都必须在 MHRA 註册，才能投放到英国市场。
一、申请资格：
1.製造商需要进行产品註册，如果製造商位于英国境外，就必须任命一名英国负责人来负责其所有医疗器材。英国负责人必须提供书面的授权证明。

2.进口商或分销商可以同时担任英国负责人。

二、申请网址：
https://mhrabpm.appiancloud.com/suite/plugins/servlet/registration
三、基本资料：
1.製造商详细资讯
．设备标籤/包装上的法人实体名称和地址
．公司类型，例如有限公司、个体工商
．管理联繫人（最多可以有 15 名人员权限）。
．英国负责人的合法授权书（如适用），声明代表製造商行事的唯一英国负责人，并代表製造商承担的强制性任务
2.设备详细资讯
．设备类别
．UDI-DI（如果适用）
．医疗器材名称（品牌/商品/专有名称）
．型号或版本
．目录/参考号
．英国认可机构（或欧盟公告机构）（如适用）
．无菌、含有乳胶、MRI等属性
．合格评定证书或自我认证合格声明的副本（如果适用）
四、费用：每份註册需缴纳 240 英镑的法定费用。
五、有效期：首次申请日期为 MHRA 完成帐户后 1 年，之后至少每 2 年要续订一次。

标籤
1.製造商的名称或商号和地址(如果製造商没有註册地点，应包含英国负责人的姓名和地址)
2.无菌的标识(如适用)
3.批次代码(LOT) 或序列号
4.以年和月表示安全使用期
5.一次性使用的标识(如适用)
6.订製设备的标识(如适用)
7.专门用于临床研究的标识(如适用)
8.任何特殊的储存和/或处理条件
9.任何特殊操作说明
10.任何警告和/或採取的预防措施
11.灭菌方法(如适用)
12.含有人类血液衍生物的标识(如适用)
13.如果设备的预期用途对用户来说不明显，製造商必须在标籤和使用说明中明确说明
14.性能和任何不良的副作用
15.如果该器材必须与其他医疗器材或设备一起安装或连接，则应提供其特性的足够详细资讯
16.维护和校正的方式和频率
17.无菌包装损坏时重新灭菌方法
18.如果器材是可重複使用的，有关重複使用的流程，包括清洁、消毒、包装，以及重新灭菌的器材的灭菌方法和重複使用次数的任何限制
19.辐射的性质、类型、强度和分佈的详细资讯(如适用)
20.禁忌症和应採取的预防措施的详细资讯
21.暴露于磁场、外部电影响、静电放电、压力或压力变化、加速度、热点火源等时应採取的预防措施
22.使用说明的发布日期或最新版本
23.标籤应以英语表示。

No. Product licenses application needs to be made by the manufacturer or his authorized UK responsible person.

All medical devices marketed in the UK, including IVDs, custom-made devices and systems or software programs, must be registered with the MHRA before they can be placed on the UK market.

1. Application qualifications:
   1.The manufacturer needs to register the product. If the manufacturer is located outside the UK, it must appoint a UK responsible person to be responsible for all its medical equipment. The UK responsible person must provide written proof of authorization. 2.The importer or distributor can act as the UK responsible person at the same time.
2. UR: https://mhrabpm.appiancloud.com/suite/plugins/servlet/registration
3. Basic information:
   1.Manufacturer details
   ． Legal entity name and address on device label/packaging
   ． Company type, such as limited company, sole proprietorship
   ． Manage contacts (up to 15 people permissions).
   ． Legal power of attorney from the UK Responsible Person (if applicable) stating the sole UK Responsible Person acting on
   　behalf of the manufacturer and the mandatory tasks undertaken on behalf of the manufacturer
   2.Device details
   ．Device category
   ．UDI-DI (if applicable)
   ．Medical Device Name (Brand/Commodity/Proprietary Name)
   ．Model or version
   ．Catalog/reference number
   ．UK Accreditation Body (or EU Notified Body) (if applicable)
   ．Sterile, latex-containing, MRI and other properties
   ．Copy of conformity assessment certificate or self-certification declaration of conformity (if applicable)
4. Fees: There is a statutory fee of £240 for each registration.
5. Validity period: The first application date is 1 year after the MHRA completes the account, and it must be renewed at least every 2 years thereafter.

Label

1. The name or trade name and address of the manufacturer (if the manufacturer has no place of registration, the name and address of the responsible person in the UK should be included)
2. Sterility identification (if applicable)
3. Lot code (LOT) or serial number
4. Indicate the safe use period in years and months
5. Single-use identification (if applicable)
6. Identification of customized device (if applicable)
7. Identification specifically used for clinical research (if applicable)
8. Any special storage and/or handling conditions
9. Any special operating instructions
10. Any warnings and/or precautions to be taken
11. Sterilization method (if applicable)
12. Identification of products containing human blood derivatives (if applicable)
13. If the intended use of the device is not obvious to the user, the manufacturer must clearly state this on the label and instructions for use
14. Performance and any adverse side effects
15. If the device must be installed or connected with other medical devices or device, sufficient details of its characteristics should be provided
16. Method and frequency of maintenance and correction
17. Re-sterilization method when the sterile packaging is damaged
18. If the device is reusable, any restrictions on the reuse process, including cleaning, disinfection, packaging, and sterilization methods and number of reuses for the device that are re-sterilized
19. Detailed information on the nature, type, intensity and distribution of radiation (if applicable)
20. Detailed information on contraindications and precautions to be taken
21. Precautions to be taken when exposed to magnetic fields, external electrical influences, electrostatic discharges, pressure or changes in pressure, acceleration, hot ignition sources, etc.
22. Date of issue or latest version of the instructions for use
23. Labels should be in English.

【参考连结】
https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market
https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk#responsible
https://www.legislation.gov.uk/uksi/2002/618/contents/made

HLF-TW-55

HLF-TW-60
经过核准登记的医疗器材，进口到英国要检附什麽文件？经过什麽手续？在销售时要向各地的卫生福利部相关机构事先或事后准备吗？网页？

What documents are required when importing approved medical devices into The United Kingdom? What is the procedure? Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?
Evershine RD：
具备产品註册的医疗器材可以进口到英国销售。
进口流程：

1. 经济运营商註册和识别号(EORI号)：如果企业位于要将货物运入或运出的国家/地区，需要先取得EORI号码。
   ．企业通常需要在进口或出口的国家/地区拥有经营场所，的场所必须是以下之一：註册办事处、中央总部、永久营业机构。
   ．如果没有资格自行申请EORI号码，则需要指定某人代表处理海关事宜。
2. 申请使用简化进口报关单
   网页：https://www.gov.uk/topic/business-tax/import-export
   ．补充声明汇总
   ．使用简化声明
   ．使用声明人记录
   ．第三方代表申请授权
   ．MHRA许可证明
3. 进口报关单(所有从英国境外进口的货物都必须向英国海关申报。)
   ．公司经济经营者註册和识别号 (EORI)
   ．公司增值税号
   ．进口原因
   ．商品描述
   ．关税号/商品代码
   ．货物价值
   ．任何可能适用的进口管制
   4.具备资料
   ．商业发票或运输发票
   ．运输文件(例如提单、空运单等)
   ．装箱单
   ．保险凭证/保单
   ．商品编码
   ．关税估价
   ．採购订单/合约
   ．海关入境文件
   ．货运代理或承运人发票
   ．附加证书

无销售通知。

Medical devices with product registration can be imported into the UK for sale.
Import process:

1. Economic Operator Registration and Identification Number (EORI Number): If the business is located in the country/region where the goods are to be shipped into or out of, it needs to obtain an EORI number first.
   ．Businesses generally need to have a place of business in the country of import or export. The place must be one of the following: registered office, central headquarters, permanent business establishment.
   ．If you are not eligible to apply for an EORI number yourself, you will need to appoint someone to represent you in customs matters.
2. Apply for the simplified import declaration form
   URL: https://www.gov.uk/topic/business-tax/import-export
   ．Summary of Supplementary Statements
   ．Use simplified declarations
   ．Use the declarant record
   ．Apply for authorization on behalf of a third party
   ．MHRA license certificate
3. Import declaration form (all goods imported from outside the UK must be declared to UK customs.)
   ．Company Economic Operator Registration and Identification Number (EORI)
   ．Company VAT number
   ．Import reason
   ．Product description
   ．Tariff number/commodity code
   ．Value of goods
   ．Any import controls that may apply
   4.Have information
   ．Commercial invoice or shipping invoice
   ．Shipping documents (e.g. bill of lading, air waybill, etc.)
   ．Packing List
   ．Insurance certificate/policy
   ．Commodity code
   ．Tariff valuation
   ．Purchase Order/Contract
   ．Customs entry documents
   ．Freight forwarder or carrier invoice
   ．Additional certificate

No sales notice.
【参考连结】
https://www.gov.uk/government/collections/guidance-for-exporting-and-importing-businesses

HLF-TW-70
英国医疗器材审核机构，需要附上的实验室检验资料有哪些? 网页？

What are the laboratory inspection materials that need to be attached for verification? Website?
Evershine RD：
1.UKCAUKCA（英国合格评定）标誌是英国产品标誌，用于在英国市场（英格兰、威尔士和苏格兰）投放的医疗器材。
2.UKCA标誌需要英国批准机构进行第三方合格评定。然而，非无菌和非测量 I 类设备以及一般体外诊断医疗器材的製造商可以根据UKCA标誌进行自我认证。
3.I 类设备：需要向认可机构申请进行合格评定以批准声明。评估类型可以是以下
．对每个产品或同质批次产品的检查和测试
．生产品质保证体系审核．
．最终检验和测试的审核
．全面品质保证体系审核

4.IIb 类设备：必须执行以下任一证明
．完整品质保证体系的审核
．型式检验加上针对上述 IIa 类设备给出的选项

5.III 类设备：必须执行以下任一证明
．完整品质保证体系的审核，包括设计档案检查
．型式检验加上针对上述 IIa 类设备给出的选项
6.符合指定标准：ISO 13485
7.临床研究

UKCA
1.The UKCA (UK Conformity Assessment) mark is a British product mark used for medical devices placed in the British market (England, Wales and Scotland).
2.The UKCA mark requires third-party conformity assessment by a British approval agency. However, manufacturers of non-sterile and non-measuring Class I devices, as well as IVDs in general, can self-certify under the UKCA mark.
3.Class I equipment: An application to an accreditation body for conformity assessment is required to approve the declaration. Assessment types can be the following
．Inspection and testing of each product or homogeneous batch of products
．Production quality assurance system audit.
．Review of final inspection and testing
．Comprehensive quality assurance system audit
4.Class IIb equipment: one of the following certifications must be performed
．Audit of complete quality assurance system
．Type examination plus options given above for class IIa equipment
5.Class III equipment: one of the following certifications must be performed
．Audit of complete quality assurance system, including design file inspection
．Type examination plus options given above for class IIa equipment
6.Comply with specified standards: ISO 13485
7.Clinical research

【参考连结】
https://www.gov.uk/guidance/medical-devices-conformity-assessment-and-the-ukca-mark

HLF-TW-75

HLF-TW-77

HLF-TW-80
外国子公司进口医疗器材后，如果委託英国的经销商销售，经销商需要医疗器材营业许可证吗？假如医疗器材有品质瑕疵的话，外国子公司和经销商各自的责任为何？是连带责任吗？还是可以规范由外国子公司负责？

After a foreign subsidiary imports medical devices and entrusts a distributor in The United Kingdom to sell it, does the distributor need a medical devices business license? What are the respective responsibilities of foreign subsidiaries and distributors if cosmetic products have quality defects? Is it joint liability? Or can the responsibility of the foreign subsidiary be regulated?
Evershine RD：
经销商无须营业许可证。

产品安全
产品的责任由製造商及英国负责人为首要。製造商需要承担放置或供应到英国市场的医疗器材发生不良事件而产生的任何法律责任；英国负责人代表非英国製造商执行与製造商义务相关的责任，但是进口、分销或销售医疗器材的企业都要对安全负责并配合改善措施。

Business license is not required.

Product Safety
Responsibility for the product rests with the manufacturer and the UK responsible person first. Manufacturers need to bear any legal liability arising from adverse events in medical devices placed or supplied to the UK market; UK responsible persons carry out responsibilities related to manufacturer obligations on behalf of non-UK manufacturers, but companies that import, distribute or sell medical devices Everyone must be responsible for safety and cooperate with improvement measures.

【参考连结】
https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market
https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk#post-market-surveillance-and-vigilance

HLF-TW-85

各国医疗器材登记法规问答集

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