英國醫療器材登記法規問題集

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時間：2023/09/08  drafted by Yvonne Chen

各國醫療器材登記法規問答集

HLF-TW-10
請問英國對於醫療器材的歸類方式為何？它的正式名稱為何？不同歸類管理強度有何差異?它的政府管轄機構為何？網頁？

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：
在英國，醫療器材由藥品和保健品監管局 ( MHRA ) 負責監管。
醫療器材的定義是：製造的目的在提供人類醫療目的上的任何裝置、器具、軟體、材料或其他物品，無論是單獨使用還是組合使用。醫療器材包括體外診斷醫療器材，也包括植入患者體內並需要外部電源的有源植入式醫療器材。

一、醫療器材等級：(依對人體的風險程度)
1.Ⅰ類：輪椅、眼鏡、聽診器、壓舌板等。
2.IIa類：牙科填充物、手術夾、氣管切開插管等。
3.IIb類：避孕套、肺部呼吸機、骨固定板等。
4.III類：心臟起搏器、心臟瓣膜、植入式腦刺激器等。

二、醫療器材分類：

1. 非侵入性：不進入人體的設備，例如膏藥、手杖、輪椅、人工腎(體外透析)等。
2. 侵入性：插入身體孔道的裝置，例如隱形眼鏡、灌腸劑、檢查手套等。
3. 手術侵入性：手術中使用或插入的裝置，例如針、手術刀、心血管導管等。
4. 主動式：需要外部電源的設備，例如X射線、超聲波、TENS等。
5. 植入式：植入體內的設備，例如乳房植入物、骨科植入物、人工晶狀體等。

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.

【參考連結】
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
外國公司要到英國銷售醫療器材，無論設100%子公司或分公司，需要在公司登記時取得營業特許證？假如要，其必要條件是什麼？所需文件及申請程序為何？網頁？

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：
無營業特許證。
No business license.

【參考連結】
https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market

HLF-TW-25

HLF-TW-30
外國公司要到英國銷售醫療器材，可以指派英國公司擔任營業代理人銷售嗎? 擔任營業代理人，其必要條件是什麼？所需文件及申請程序為何？外國公司與營業代理人的產品責任為何?網頁？

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，醫療器材法規沒有特別規範營業代理人條件。

產品安全
產品的責任由製造商及英國負責人為首要。製造商需要承擔放置或供應到英國市場的醫療器材發生不良事件而產生的任何法律責任；英國負責人代表非英國製造商執行與製造商義務相關的責任，但是進口、分銷或銷售醫療器材的企業都要對安全負責並配合改善措施。

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.

【參考連結】
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
外國公司銷售到英國醫療器材本身，進口前需要辦理產品許可嗎？如需要，哪個單位在管理？需要什麼文件？申請程序為何？醫療器材包裝內容及各種標識，需要事先核准嗎？可允許的語文有哪些？網頁？

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，需完成醫療器材產品註冊。
在英國上市的所有醫療器材，包括體外診斷醫療器材、訂製器材和系統或軟體程式，都必須在 MHRA 註冊，才能投放到英國市場。
一、申請資格：
1.製造商需要進行產品註冊，如果製造商位於英國境外，就必須任命一名英國負責人來負責其所有醫療器材。英國負責人必須提供書面的授權證明。

2.進口商或分銷商可以同時擔任英國負責人。

二、申請網址：
https://mhrabpm.appiancloud.com/suite/plugins/servlet/registration

三、基本資料：
1.製造商詳細資訊
．設備標籤/包裝上的法人實體名稱和地址
．公司類型，例如有限公司、個體工商
．管理聯繫人（最多可以有 15 名人員權限）。
．英國負責人的合法授權書（如適用），聲明代表製造商行事的唯一英國負責人，並代表製造商承擔的強制性任務
2.設備詳細資訊
．設備類別
．UDI-DI（如果適用）
．醫療器材名稱（品牌/商品/專有名稱）
．型號或版本
．目錄/參考號
．英國認可機構（或歐盟公告機構）（如適用）
．無菌、含有乳膠、MRI等屬性
．合格評定證書或自我認證合格聲明的副本（如果適用）
四、費用：每份註冊需繳納 240 英鎊的法定費用。
五、有效期：首次申請日期為 MHRA 完成帳戶後 1 年，之後至少每 2 年要續訂一次。

標籤
1.製造商的名稱或商號和地址(如果製造商沒有註冊地點，應包含英國負責人的姓名和地址)
2.無菌的標識(如適用)
3.批次代碼(LOT) 或序列號
4.以年和月表示安全使用期
5.一次性使用的標識(如適用)
6.訂製設備的標識(如適用)
7.專門用於臨床研究的標識(如適用)
8.任何特殊的儲存和/或處理條件
9.任何特殊操作說明
10.任何警告和/或採取的預防措施
11.滅菌方法(如適用)
12.含有人類血液衍生物的標識(如適用)
13.如果設備的預期用途對用戶來說不明顯，製造商必須在標籤和使用說明中明確說明
14.性能和任何不良的副作用
15.如果該器材必須與其他醫療器材或設備一起安裝或連接，則應提供其特性的足夠詳細資訊
16.維護和校正的方式和頻率
17.無菌包裝損壞時重新滅菌方法
18.如果器材是可重複使用的，有關重複使用的流程，包括清潔、消毒、包裝，以及重新滅菌的器材的滅菌方法和重複使用次數的任何限制
19.輻射的性質、類型、強度和分佈的詳細資訊(如適用)
20.禁忌症和應採取的預防措施的詳細資訊
21.暴露於磁場、外部電影響、靜電放電、壓力或壓力變化、加速度、熱點火源等時應採取的預防措施
22.使用說明的發布日期或最新版本
23.標籤應以英語表示。

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.

【參考連結】
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
外國公司可以用自己名義申請辦理產品許可嗎？如需要，哪個單位在管理？需要什麼文件？申請程序為何？醫療器材包裝內容及各種標識，需要事先核准嗎？可允許的語文有哪些？？網頁？

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，需由製造商或其授權英國負責人進行產品註冊人，進口商可以做為同時擔任英國負責人。

在英國上市的所有醫療器材，包括體外診斷醫療器材、訂製器材和系統或軟體程式，都必須在 MHRA 註冊，才能投放到英國市場。
一、申請資格：
1.製造商需要進行產品註冊，如果製造商位於英國境外，就必須任命一名英國負責人來負責其所有醫療器材。英國負責人必須提供書面的授權證明。

2.進口商或分銷商可以同時擔任英國負責人。

二、申請網址：
https://mhrabpm.appiancloud.com/suite/plugins/servlet/registration
三、基本資料：
1.製造商詳細資訊
．設備標籤/包裝上的法人實體名稱和地址
．公司類型，例如有限公司、個體工商
．管理聯繫人（最多可以有 15 名人員權限）。
．英國負責人的合法授權書（如適用），聲明代表製造商行事的唯一英國負責人，並代表製造商承擔的強制性任務
2.設備詳細資訊
．設備類別
．UDI-DI（如果適用）
．醫療器材名稱（品牌/商品/專有名稱）
．型號或版本
．目錄/參考號
．英國認可機構（或歐盟公告機構）（如適用）
．無菌、含有乳膠、MRI等屬性
．合格評定證書或自我認證合格聲明的副本（如果適用）
四、費用：每份註冊需繳納 240 英鎊的法定費用。
五、有效期：首次申請日期為 MHRA 完成帳戶後 1 年，之後至少每 2 年要續訂一次。

標籤
1.製造商的名稱或商號和地址(如果製造商沒有註冊地點，應包含英國負責人的姓名和地址)
2.無菌的標識(如適用)
3.批次代碼(LOT) 或序列號
4.以年和月表示安全使用期
5.一次性使用的標識(如適用)
6.訂製設備的標識(如適用)
7.專門用於臨床研究的標識(如適用)
8.任何特殊的儲存和/或處理條件
9.任何特殊操作說明
10.任何警告和/或採取的預防措施
11.滅菌方法(如適用)
12.含有人類血液衍生物的標識(如適用)
13.如果設備的預期用途對用戶來說不明顯，製造商必須在標籤和使用說明中明確說明
14.性能和任何不良的副作用
15.如果該器材必須與其他醫療器材或設備一起安裝或連接，則應提供其特性的足夠詳細資訊
16.維護和校正的方式和頻率
17.無菌包裝損壞時重新滅菌方法
18.如果器材是可重複使用的，有關重複使用的流程，包括清潔、消毒、包裝，以及重新滅菌的器材的滅菌方法和重複使用次數的任何限制
19.輻射的性質、類型、強度和分佈的詳細資訊(如適用)
20.禁忌症和應採取的預防措施的詳細資訊
21.暴露於磁場、外部電影響、靜電放電、壓力或壓力變化、加速度、熱點火源等時應採取的預防措施
22.使用說明的發布日期或最新版本
23.標籤應以英語表示。

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.

【參考連結】
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
經過核准登記的醫療器材，進口到英國要檢附什麼文件？經過什麼手續？在銷售時要向各地的衛生福利部相關機構事先或事後準備嗎？網頁？

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：
具備產品註冊的醫療器材可以進口到英國銷售。
進口流程：

1. 經濟運營商註冊和識別號(EORI號)：如果企業位於要將貨物運入或運出的國家/地區，需要先取得EORI號碼。
   ．企業通常需要在進口或出口的國家/地區擁有經營場所，的場所必須是以下之一：註冊辦事處、中央總部、永久營業機構。
   ．如果沒有資格自行申請EORI號碼，則需要指定某人代表處理海關事宜。
2. 申請使用簡化進口報關單
   網頁：https://www.gov.uk/topic/business-tax/import-export
   ．補充聲明匯總
   ．使用簡化聲明
   ．使用聲明人記錄
   ．第三方代表申請授權
   ．MHRA許可證明
3. 進口報關單(所有從英國境外進口的貨物都必須向英國海關申報。)
   ．公司經濟經營者註冊和識別號 (EORI)
   ．公司增值稅號
   ．進口原因
   ．商品描述
   ．關稅號/商品代碼
   ．貨物價值
   ．任何可能適用的進口管制
   4.具備資料
   ．商業發票或運輸發票
   ．運輸文件(例如提單、空運單等)
   ．裝箱單
   ．保險憑證/保單
   ．商品編碼
   ．關稅估價
   ．採購訂單/合約
   ．海關入境文件
   ．貨運代理或承運人發票
   ．附加證書

無銷售通知。

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.
【參考連結】
https://www.gov.uk/government/collections/guidance-for-exporting-and-importing-businesses

HLF-TW-70
英國醫療器材審核機構，需要附上的實驗室檢驗資料有哪些? 網頁？

What are the laboratory inspection materials that need to be attached for verification? Website?
Evershine RD：
1.UKCAUKCA（英國合格評定）標誌是英國產品標誌，用於在英國市場（英格蘭、威爾士和蘇格蘭）投放的醫療器材。
2.UKCA標誌需要英國批准機構進行第三方合格評定。然而，非無菌和非測量 I 類設備以及一般體外診斷醫療器材的製造商可以根據UKCA標誌進行自我認證。
3.I 類設備：需要向認可機構申請進行合格評定以批准聲明。評估類型可以是以下
．對每個產品或同質批次產品的檢查和測試
．生產品質保證體系審核．
．最終檢驗和測試的審核
．全面品質保證體系審核

4.IIb 類設備：必須執行以下任一證明
．完整品質保證體系的審核
．型式檢驗加上針對上述 IIa 類設備給出的選項

5.III 類設備：必須執行以下任一證明
．完整品質保證體系的審核，包括設計檔案檢查
．型式檢驗加上針對上述 IIa 類設備給出的選項
6.符合指定標準：ISO 13485
7.臨床研究

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

【參考連結】
https://www.gov.uk/guidance/medical-devices-conformity-assessment-and-the-ukca-mark

HLF-TW-75

HLF-TW-77

HLF-TW-80
外國子公司進口醫療器材後，如果委託英國的經銷商銷售，經銷商需要醫療器材營業許可證嗎？假如醫療器材有品質瑕疵的話，外國子公司和經銷商各自的責任為何？是連帶責任嗎？還是可以規範由外國子公司負責？

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：
經銷商無須營業許可證。

產品安全
產品的責任由製造商及英國負責人為首要。製造商需要承擔放置或供應到英國市場的醫療器材發生不良事件而產生的任何法律責任；英國負責人代表非英國製造商執行與製造商義務相關的責任，但是進口、分銷或銷售醫療器材的企業都要對安全負責並配合改善措施。

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.

【參考連結】
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

各國醫療器材登記法規問答集

Email：lon4ww@evershinecpa.com
或
英國永輝BPO有限公司
Nady Wong, CA in ACCA說中文和英文
或
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