西班牙醫療器材登記法規問題集

西班牙主要城市公司設立登記,商標登記，進出口證，特許行業申請等。公司設立後雲端系統支援的會計薪資服務。西班牙與臺灣同事攜手協同爲您服務。為地球暖化盡一份心力，減少空中旅行。
Email：bcn4ww@evershinecpa.com
或
西班牙永輝BPO有限公司
Barcelona time zone:
Anna Wang, 說西班牙文中文和英文
或
China Time Zone:
聯絡人: 陳中成 Dale Chen 會計師/所長
手機：+886-933-920-199
skype: Daleccchen
wechat: Evershiinecpa
電話：+886-2-2717-0515 分機:100

各國醫療器材登記法規問答集

時間：2022/10/28 drafted by Yvonne Chen

HLF-TW-10
請問西班牙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 Spain? 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：
在西班牙，西班牙藥品和保健品局 (AEMPS)是醫療器材的監管機構。
醫療器材是指用於人體的單獨或組合使用的任何儀器、裝置、設備、電腦程式、材料或其他物品，用於特定診斷和/或治療目的：
1.疾病的診斷、預防、控制、治療或緩解
2.第二次診斷、控制、治療、緩解或補償傷害/缺陷
3.第三次檢查、替換或修改結構解剖或生理過程
4.第四條調節受孕
應用於人體的體外檢查，包括器官、血液和組織，並且不能通過藥理學、免疫學或代謝方式在人體內或人體內實現其主要預期作用，但可以通過這些醫療器材輔助其功能。

產品分為I類、IIa類、IIb類、III類
•I 類：最低風險類別
不與患者接觸或僅與完整皮膚接觸的產品，透過身體開口（例如嘴或鼻子）進入以供臨時使用的產品。
•IIa 類：中度/潛在風險
包括透過身體孔口或透過手術方式（即透過皮膚）引入人體但不打算保留在那裡的產品。還有提供能量或物質的產品，或是改變生理過程的物質，只要不是以潛在危險的方式進行的。
•IIb 類：潛在高/顯著風險
包括一些植入式產品、可以影響生理過程或以潛在危險方式管理物質的產品，以及用於診斷生命功能的產品。
•III 類：最高風險類別
包括一些植入式產品、旨在與中樞神經系統或中樞循環系統接觸用於治療或診斷目的的產品、含有藥用物質的產品、完全吸收的產品以及含有動物衍生物的產品。

In Spain, the Spanish Agency for Medicines and Healthcare Products (AEMPS) is the regulatory agency for medical devices.
Medical device means any instrument, device, equipment, computer program, material or other article used alone or in combination with the human body for specific diagnostic and/or therapeutic purposes:

1. Diagnosis, prevention, control, treatment or alleviation of disease
2. Second diagnosis, control, treatment, mitigation or compensation of injury/deficiency
3. The third inspection, replacement or modification of structural anatomy or physiological processes
4. Article 4 Regulation of Conception
   Applied to in vitro examinations of the human body, including organs, blood and tissues, and which cannot achieve their main intended role in or within the human body through pharmacological, immunological or metabolic means, but can assist their functions through these medical devices.

Products are divided into Class I, Class IIa, Class IIb and Class III
•Class I: Lowest risk category
Products that do not come into contact with the patient or come into contact only with intact skin, products that enter through a body opening (such as the mouth or nose) for temporary use.
•Class IIa: Moderate/Potential Risk
Includes products that are introduced into the body through body orifices or surgically (i.e. through the skin) but are not intended to remain there. There are also products that provide energy or substances, or substances that alter physiological processes, as long as they are not done in a potentially dangerous way.
•Class IIb: Potentially high/significant risk
Includes some implantable products, products that can affect physiological processes or administer substances in potentially dangerous ways, and products used to diagnose vital functions.
•Class III: Highest risk category
Includes some implantable products, products intended to come into contact with the central nervous system or central circulatory system for therapeutic or diagnostic purposes, products containing medicinal substances, completely absorbed products, and products containing animal derivatives.

【參考連結】
https://www.aemps.gob.es/
https://www.boe.es/buscar/doc.php?id=BOE-A-2009-17606

HLF-TW-20
外國公司要到西班牙銷售醫療器材，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 Spain, 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.boe.es/buscar/doc.php?id=BOE-A-2009-17606

HLF-TW-25

HLF-TW-30
外國公司要到西班牙銷售醫療器材，可以指派西班牙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 Spain, can it assign an Spain 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。
營業代理人需要是位於歐盟國家且是在歐盟境內營運的供應鏈一部分的合法公司，且必須善盡確保醫療器材符合歐盟CE標準、承擔分銷商的義務。
營業代理人在引進產品之前，應確保該產品具有CE標誌(如果適用)，並且製造商已在歐盟指定代表，已進行相應的合格評定並已準備好所需的技術文件。

產品安全
製造商應負起監督責任，但如果沒有這樣做的話，授權代表、進口商或分銷商，必須在得知以下事實後立即向西班牙藥品和保健品局發送通知，並告知糾正措施。
1.任何有缺陷的操作或產品特性或性能的改變，以及標籤或使用說明的任何不充分，可能導致或可能已經導致患者或健康狀況嚴重惡化。
2.與產品特性或性能相關的任何技術或健康性質的原因，促使製造商對同類產品採取系統性措施。

Yes.
The sales agent needs to be a legal company located in an EU country and part of the supply chain operating within the EU, and must ensure that medical devices comply with EU CE standards and assume the obligations of a distributor.

Before introducing a product, the sales agent should ensure that the product has the CE mark (if applicable), and that the manufacturer has designated a representative in the EU, has conducted the corresponding conformity assessment and has prepared the required technical documents.

Product Safety
The manufacturer shall assume the responsibility for supervision, but if this is not done, the authorized representative, importer or distributor must immediately send a notification to the Spanish Agency for Medicines and Health Products upon becoming aware of the following facts and inform them of corrective measures.

1. Any defective operation or alteration in the characteristics or performance of the product, as well as any inadequacy of the labeling or instructions for use, may cause or may have caused a serious deterioration of the patient or health condition.
2. Any technical or health reasons related to the characteristics or performance of the product prompt the manufacturer to take systematic measures against similar products.

【參考連結】
https://www.boe.es/buscar/doc.php?id=BOE-A-2009-17606
https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices
https://notificaps.aemps.es/enviotelematico/notificaps/notifica/inicio.do
https://www.boe.es/buscar/doc.php?id=BOE-A-2009-17606

HLF-TW-35

HLF-TW-40
外國公司銷售到西班牙醫療器材本身，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示，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 Spain? 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：
需以西班牙或歐盟成員國的公司身分於歐盟網站(EUDAMED)註冊醫療器材，並於歐盟成員國中其中一個國家註冊產品。

歐盟(EUDAMED)註冊流程
1.角色註冊(製造商/授權代表/進口商)
．公司名稱/申請人名稱
．聯繫電話、Email
．國家、城市、街道、郵遞區號等
2.UDI/設備註冊
．製造商名稱、地址
．風險等級
．測量功能(是/否)
．可重複用的手術器材(是/否)
．有源設備(是/否)
．辨識設備型號
．技術文件或合格證書/聲明
．設備數量
．使用單位
．臨床規模
．附加產品說明
．一次性使用(是/否)
．最大重複使用次數
．是否需要滅菌
．含乳膠(是/否)
．CMR/內分泌干擾物
．嚴重警告或禁忌
．醫療器材命名法 (CND) 代碼等
3.證書和公告機構
．產品類別證書： 歐盟型式檢驗證書、歐盟技術文件證書、 歐盟產品驗證證書。
．品質等級證書：歐盟品質管理體系證書、歐盟品質保證證書、 歐盟生產品質保證證書。
4.臨床調查和性能研究(開發中)
5.警示和上市後監督(開發中)
6.市場監督(開發中)
7.歐盟頒發的許可證有效期為5年。

標籤
文件和標籤都必須用西班牙語標示，必須包含以下資料：
．製造商的名稱或公司名稱和地址。進口到歐盟領土並打算在其中進行分銷的產品，如果製造商在歐盟內沒有註冊辦事處，那麼標籤、外包裝或使用說明還必須包括授權代表的姓名、地址。
．辨識產品和包裝內容物(特別是使用者)所需的資訊。
．在適當的情況下，使用無菌一詞。
．批次程式碼前面有批次一詞或序號(視情況而定)。
．產品完全安全的日期，以年和月表示。
．關於產品為一次性使用的說明必須保持一致(如果適用)。
．若是客製化產品，須註明客製化產品。
．若是臨床研究的產品，須註明僅供臨床研究。
．具體儲存和/或保存條件。
．特別使用說明。
．必須採取的任何警告和/或預防措施。
．滅菌方法(如果適用)。
．該產品的組成部分含有源自人體血液的物質 (如果適用)。
．如果產品的預期用途對使用者來說不明顯，製造商必須在標籤和使用說明中明確說明。
．在合理可行的情況下，產品及其可分離組件必須按批次辨識，以便採取適當措施檢測與產品及其可分離組件相關的可能風險。
使用說明必須酌情包含以下：
．可能的不良副作用。
．如果產品必須與其他醫療保健產品或設備安裝或連接才能實現其預期目的，則必須包含有關其特性的足夠資訊，以辨識要使用的正確產品或設備，以便安全使用組合。
．驗證產品是否正確安裝、完全安全運行的所有資料，以及必須永久性維護和校準的頻率，確保產品保持良好的性能和安全性。
．有助於避免與產品實施相關的某些風險的資訊(如果適用)。
．與特定調查或治療中產品的存在相關的相互干擾風險的資訊。
．無菌包裝破損時的必要說明，以及適當的再滅菌方法(如果適用)。
．重複使用的適當程序，包括清潔、消毒、調節，以及適用時的滅菌方法(如果需要)，以及限制重複使用次數。
．如果產品在使用前必須進行滅菌，則必須制定清潔和滅菌說明。
．如果產品僅供一次性使用，則應提供已知的特性和技術因素，如果再次使用該產品可能會帶來風險。
．使用產品之前必須進行的任何附加處理或操作的資訊。
．當產品發射用於醫療目的的輻射時，與所述輻射的性質、類型、強度和分佈相關的資訊。
．使用說明必須包括允許醫務人員告知患者禁忌症和應採取的預防措施的資訊。

Medical devices need to be registered on the EU website (EUDAMED) as a company in Spain or an EU member state, and the product must be registered in one of the EU member states.

EU (EUDAMED) registration process

1. Role registration (manufacturer/authorized representative/importer)
   ．Company name/Applicant name
   ．Contact number, email
   ．Country, city, street, postal code, etc.
   2.UDI/Device Registration
   ．Manufacturer’s name, address
   ．Risk level
   ．Measurement function (yes/no)
   ．Reusable surgical equipment (yes/no)
   ．Active device (yes/no)
   ．Identify device model
   ．Technical documentation or certificate/declaration of conformity
   ．Equipment Quantity
   ．Use unit
   ．Clinical scale
   ．Additional product description
   ．Single use (yes/no)
   ．Maximum number of reuses
   ．Whether sterilization is required
   ．Contains latex (yes/no)
   ．CMR/endocrine disruptors
   ．SERIOUS WARNINGS OR CONTRAINDICATIONS
   ．Medical Device Nomenclature (CND) codes, etc.
2. Certificates and Notified Bodies
   ．Product category certificates: EU type inspection certificate, EU technical document certificate, EU product verification certificate.
   ．Quality grade certificate: EU Quality Management System Certificate, EU Quality Assurance Certificate, EU Production Quality Assurance Certificate.
3. Clinical investigation and performance studies (under development)
4. Warning and post-market surveillance (under development)
5. Market supervision (under development)
6. The license issued by the EU is valid for 5 years.

Label
Both documents and labels must be in Spanish and must contain the following information:
．Manufacturer’s name or company name and address. For products imported into EU territory and intended for distribution therein, if the manufacturer does not have a registered office in the EU, the label, outer packaging or instructions for use must also include the name and address of the authorized representative.
．Information needed to identify the product and package contents, especially to the user.
．Where appropriate, use the term sterile.
．The batch code is preceded by the word batch or a serial number, as appropriate.
．The date the product is completely safe, expressed in months and years.
．Instructions that the product is for single use must be consistent (if applicable).
．If it is a customized product, the customized product must be indicated.
．If it is a product for clinical research, it must be stated that it is for clinical research only.
．Specific storage and/or preservation conditions.
．Special instructions for use.
．Any warnings and/or precautions that must be taken.
．Sterilization method (if applicable).
．This product contains components derived from human blood, where applicable.
．If the intended use of a product is not obvious to the user, the manufacturer must state this clearly in the label and instructions for use.
．Where reasonably practicable, products and their separable components must be identified on a batch-by-batch basis so that appropriate measures can be taken to detect possible risks associated with the product and its separable components.
Instructions for use must include the following, where appropriate:
．Possible adverse side effects.
．If a product must be installed or connected to other healthcare products or devices to achieve its intended purpose, it must contain sufficient information about its characteristics to identify the correct product or device to be used so that the combination can be used safely.
．All information that verifies that the product is installed correctly, operates completely safely, and how frequently maintenance and calibration must be performed permanently to ensure that the product maintains good performance and safety.
．Information to help avoid certain risks associated with product implementation, if applicable.
．Information about the risk of interference associated with the presence of products under particular investigation or treatment.
．Necessary instructions in the event of damage to sterile packaging, and appropriate resterilization methods, if applicable.
．Appropriate procedures for reuse, including cleaning, disinfection, conditioning, and when applicable, sterilization methods (if required), and limiting the number of reuses.
．If a product must be sterilized before use, cleaning and sterilization instructions must be developed.
．If the product is intended for single use only, the characteristics and technical factors should be provided that are known to present risks if the product is used again.
．Information about any additional processing or operations that must be performed before using the product.
．When a product emits radiation for medical purposes, information related to the nature, type, intensity and distribution of that radiation.
．Instructions for use must include information that allows the healthcare provider to inform the patient of contraindications and precautions to be taken.

【參考連結】
https://www.boe.es/buscar/doc.php?id=BOE-A-2009-17606
https://ec.europa.eu/tools/eudamed/#/screen/home
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A31997D0129

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示，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，需以西班牙或歐盟成員國的公司身分於歐盟網站(EUDAMED)註冊醫療器材，並於歐盟成員國中其中一個國家註冊產品。

歐盟(EUDAMED)註冊流程
1.角色註冊(製造商/授權代表/進口商)
．公司名稱/申請人名稱
．聯繫電話、Email
．國家、城市、街道、郵遞區號等
2.UDI/設備註冊
．製造商名稱、地址
．風險等級
．測量功能(是/否)
．可重複用的手術器材(是/否)
．有源設備(是/否)
．辨識設備型號
．技術文件或合格證書/聲明
．設備數量
．使用單位
．臨床規模
．附加產品說明
．一次性使用(是/否)
．最大重複使用次數
．是否需要滅菌
．含乳膠(是/否)
．CMR/內分泌干擾物
．嚴重警告或禁忌
．醫療器材命名法 (CND) 代碼等
3.證書和公告機構
．產品類別證書： 歐盟型式檢驗證書、歐盟技術文件證書、 歐盟產品驗證證書。
．品質等級證書：歐盟品質管理體系證書、歐盟品質保證證書、 歐盟生產品質保證證書。
4.臨床調查和性能研究(開發中)
5.警示和上市後監督(開發中)
6.市場監督(開發中)
7.歐盟頒發的許可證有效期為5年。

標籤
文件和標籤都必須用西班牙語標示，必須包含以下資料：
．製造商的名稱或公司名稱和地址。進口到歐盟領土並打算在其中進行分銷的產品，如果製造商在歐盟內沒有註冊辦事處，那麼標籤、外包裝或使用說明還必須包括授權代表的姓名、地址。
．辨識產品和包裝內容物(特別是使用者)所需的資訊。
．在適當的情況下，使用無菌一詞。
．批次程式碼前面有批次一詞或序號(視情況而定)。
．產品完全安全的日期，以年和月表示。
．關於產品為一次性使用的說明必須保持一致(如果適用)。
．若是客製化產品，須註明客製化產品。
．若是臨床研究的產品，須註明僅供臨床研究。
．具體儲存和/或保存條件。
．特別使用說明。
．必須採取的任何警告和/或預防措施。
．滅菌方法(如果適用)。
．該產品的組成部分含有源自人體血液的物質 (如果適用)。
．如果產品的預期用途對使用者來說不明顯，製造商必須在標籤和使用說明中明確說明。
．在合理可行的情況下，產品及其可分離組件必須按批次辨識，以便採取適當措施檢測與產品及其可分離組件相關的可能風險。
使用說明必須酌情包含以下：
．可能的不良副作用。
．如果產品必須與其他醫療保健產品或設備安裝或連接才能實現其預期目的，則必須包含有關其特性的足夠資訊，以辨識要使用的正確產品或設備，以便安全使用組合。
．驗證產品是否正確安裝、完全安全運行的所有資料，以及必須永久性維護和校準的頻率，確保產品保持良好的性能和安全性。
．有助於避免與產品實施相關的某些風險的資訊(如果適用)。
．與特定調查或治療中產品的存在相關的相互干擾風險的資訊。
．無菌包裝破損時的必要說明，以及適當的再滅菌方法(如果適用)。
．重複使用的適當程序，包括清潔、消毒、調節，以及適用時的滅菌方法(如果需要)，以及限制重複使用次數。
．如果產品在使用前必須進行滅菌，則必須制定清潔和滅菌說明。
．如果產品僅供一次性使用，則應提供已知的特性和技術因素，如果再次使用該產品可能會帶來風險。
．使用產品之前必須進行的任何附加處理或操作的資訊。
．當產品發射用於醫療目的的輻射時，與所述輻射的性質、類型、強度和分佈相關的資訊。
．使用說明必須包括允許醫務人員告知患者禁忌症和應採取的預防措施的資訊。

No, you need to register the medical device on the EU website (EUDAMED) as a company in Spain or an EU member state, and register the product in one of the EU member states.

EU (EUDAMED) registration process

1. Role registration (manufacturer/authorized representative/importer)
   ．Company name/Applicant name
   ．Contact number, email
   ．Country, city, street, postal code, etc.
   2.UDI/Device Registration
   ．Manufacturer’s name, address
   ．Risk level
   ．Measurement function (yes/no)
   ．Reusable surgical equipment (yes/no)
   ．Active device (yes/no)
   ．Identify device model
   ．Technical documentation or certificate/declaration of conformity
   ．Equipment Quantity
   ．Use unit
   ．Clinical scale
   ．Additional product description
   ．Single use (yes/no)
   ．Maximum number of reuses
   ．Whether sterilization is required
   ．Contains latex (yes/no)
   ．CMR/endocrine disruptors
   ．SERIOUS WARNINGS OR CONTRAINDICATIONS
   ．Medical Device Nomenclature (CND) codes, etc.
2. Certificates and Notified Bodies
   ．Product category certificates: EU type inspection certificate, EU technical document certificate, EU product verification certificate.
   ．Quality grade certificate: EU Quality Management System Certificate, EU Quality Assurance Certificate, EU Production Quality Assurance Certificate.
   4.Clinical investigation and performance studies (under development)
3. Warning and post-market surveillance (under development)
4. Market supervision (under development)
5. The license issued by the EU is valid for 5 years.

Label
Both documents and labels must be in Spanish and must contain the following information:
．Manufacturer’s name or company name and address. For products imported into EU territory and intended for distribution therein, if the manufacturer does not have a registered office in the EU, the label, outer packaging or instructions for use must also include the name and address of the authorized representative.
．Information needed to identify the product and package contents, especially to the user.
．Where appropriate, use the term sterile.
．The batch code is preceded by the word batch or a serial number, as appropriate.
．The date the product is completely safe, expressed in months and years.
．Instructions that the product is for single use must be consistent (if applicable).
．If it is a customized product, the customized product must be indicated.
．If it is a product for clinical research, it must be stated that it is for clinical research only.
．Specific storage and/or preservation conditions.
．Special instructions for use.
．Any warnings and/or precautions that must be taken.
．Sterilization method (if applicable).
．This product contains components derived from human blood, where applicable.
．If the intended use of a product is not obvious to the user, the manufacturer must state this clearly in the label and instructions for use.
．Where reasonably practicable, products and their separable components must be identified on a batch-by-batch basis so that appropriate measures can be taken to detect possible risks associated with the product and its separable components.
Instructions for use must include the following, where appropriate:
．Possible adverse side effects.
．If a product must be installed or connected to other healthcare products or devices to achieve its intended purpose, it must contain sufficient information about its characteristics to identify the correct product or device to be used so that the combination can be used safely.
．All information that verifies that the product is installed correctly, operates completely safely, and how frequently maintenance and calibration must be performed permanently to ensure that the product maintains good performance and safety.
．Information to help avoid certain risks associated with product implementation, if applicable.
．Information about the risk of interference associated with the presence of products under particular investigation or treatment.
．Necessary instructions in the event of damage to sterile packaging, and appropriate resterilization methods, if applicable.
．Appropriate procedures for reuse, including cleaning, disinfection, conditioning, and when applicable, sterilization methods (if required), and limiting the number of reuses.
．If a product must be sterilized before use, cleaning and sterilization instructions must be developed.
．If the product is intended for single use only, the characteristics and technical factors should be provided that are known to present risks if the product is used again.
．Information about any additional processing or operations that must be performed before using the product.
．When a product emits radiation for medical purposes, information related to the nature, type, intensity and distribution of that radiation.
．Instructions for use must include information that allows the healthcare provider to inform the patient of contraindications and precautions to be taken.

【參考連結】
https://www.boe.es/buscar/doc.php?id=BOE-A-2009-17606
https://ec.europa.eu/tools/eudamed/#/screen/home
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A31997D0129

HLF-TW-55

HLF-TW-60
經過核准登記的醫療器材，進口到西班牙要檢附什麼文件？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 Spain? What is the procedure? Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?
Evershine RD：
進口許可證
從第三國進口醫療器材和產品，需取得西班牙藥品和醫療器材局(AEMPS) 頒發的進口許可證。
1.申請人：自然人或法人
2.申請網頁：https://sede.aemps.gob.es/en/procedimientos-y-servicios/tramites-mas-usados.html
3.進口許可證期限：3到6個月
4.文件
．技術報告：說明如何在設施、流程和認證等方面遵守現行法規。
．擁有 AEMPS 批准的內部或外包倉儲，倉庫的大小將取決於公司的活動和所涉及的產品類型。
．具備一名合格人員，除其他職責外，負責批次放行和分發。未經合格人員授權，公司不得銷售進口產品。

海關

1. 經濟經營者註冊和識別(EORI)
   向西班牙海關( OEA )申請取得 EORI 號碼
   網頁：https://sede.agenciatributaria.gob.es/Sede/inicio.html
   申請書內容
   ．自然人：護照或其他有效身分證件；公司名稱/責任人姓名
   ．西班牙的納稅住所。
   ．創建日期/生日
   ．人員類型：自然人/法人/團體
   ．地址、電話、電子郵件
   ．聯絡資訊、聯絡人姓名、地址、電話號碼、傳真號碼、電子郵件
   ．商業登記證明
   ．如果申請人不是自然人，也不是被授予EORI代碼的法人或團體的法定代表人則必須繳交：經公證的授權書正本、授權書原件
   ．經濟活動部門4位代碼：商業登記處註明的歐盟經濟活動統計分類(NACE)主要經濟活動的4位數代碼
2. 報關
   申報單內容
   ．運營商的名稱和EORI
   ．清關辦事處代碼
   ．報關處代碼
   ．包裹數量
   ．發件人的姓名和地址、收件人的姓名和地址
   ．商品的商業描述
   ．以千克為單位的總質量
   ．原產國代碼
   ．發票價值和貨幣
   ．進口聲明等
   單一行政文件 (SAD)
   ．託運人
   ．收件人
   ．申報人
   ．出發時運輸工具、國家
   ．過境運輸工具、國家
   ．運輸方式
   ．商業編號
   ．付款方式
   ．目的地代碼
   ．交貨條款
   ．交易性質
   ．貨櫃編號、密封貼及編號
   ．商品代碼、重量
   ．稅務計算
   ．抵港日期
   ．辦事處
   ．聲明人等
3. 清關所需文件
   ．商業發票副本 (西班牙語)
   ．原產地聲明

行銷通知
1.任何自然人或法人首次在西班牙境內提供 IIa、IIb 或 III 類產品供分銷和/或使用時，應向西班牙藥品和保健品管理局聯繫。
2.網頁：
https://sede.aemps.gob.es/en/procedimientos-y-servicios/tramites-mas-usados.html
3.通知內容
．自然人/法人的身分資料
．產品所屬類別
．產品在西班牙的商業名稱以及產品在歐盟銷售的商業名稱(如果與第一個名稱不同)
．產品類別、類型和型號
．產品的描述和預期用途
．製造商、製造地點及其授權代表的資料(如果適用)
．CE 標誌、應用附件和 CE 合格證書副本的評定指定機構辨識號碼
．公告機構認證的標籤和使用說明
．產品將在西班牙銷售的標籤和使用說明(西班牙語)
．在西班牙上市或投入使用的日期
．西班牙經銷商的身份資料

Importing medical equipment and products from third countries requires an import license issued by the Spanish Agency for Medicines and Medical Devices (AEMPS).

1. Applicant: natural person or legal person
2. Application webpage: https://sede.aemps.gob.es/en/procedimientos-y-servicios/tramites-mas-usados.html
3. Import license period: 3 to 6 months
4. Documents
   ．Technical Report: Describes how to comply with current regulations in terms of facilities, processes and certifications.
   ．With AEMPS approved in-house or outsourced warehousing, the size of the warehouse will depend on the company’s activities and the types of products involved.
   ．Have a qualified person responsible for batch release and distribution, among other duties. Companies are not allowed to sell imported products without authorization from qualified personnel.

Customs

1. Economic Operator Registration and Identification (EORI)
   Apply to Spanish Customs (OEA) to obtain an EORI number
   URL: https://sede.agenciatributaria.gob.es/Sede/inicio.html
   Application content
   ．Natural person: passport or other valid identity document; company name/name of responsible person
   ．Spanish tax residence.
   ．Creation date/birthday
   ．Personnel type: natural person/legal person/group
   ．Address, phone number, email
   ．Contact information, contact name, address, telephone number, fax number, email
   ．Business registration certificate
   ．If the applicant is not a natural person, nor is he the legal representative of a legal person or group that has been granted an EORI code, he must submit: the original notarized power of attorney, and the original power of attorney.
   ．4-digit code of the economic activity sector: the 4-digit code of the main economic activity in the Statistical Classification of Economic Activity in the European Union (NACE) indicated in the commercial register
2. Customs declaration
   Declaration form content
   ．Operator’s name and EORI
   ．Customs clearance office code
   ．Customs declaration office code
   ．Package quantity
   ．Sender’s name and address, Recipient’s name and address
   ．Commercial description of the product
   ．Total mass in kilograms
   ．Country of origin code
   ．Invoice value and currency
   ．Import declaration, etc.
   Single Administrative Document (SAD)
   ．Shipper
   ．Recipient
   ．Notifier
   ．Means of transportation and country at departure
   ．Transit transport, country
   ．Transportation method
   ．Business number
   ．Payment method
   ．Destination code
   ．Terms of Delivery
   ．Nature of transaction
   ．Container number, sealing sticker and serial number
   ．Product code, weight
   ．Tax calculation
   ．Arrival date
   ．Office
   ．Declarant etc.
3. Documents required for customs clearance
   ．Copy of commercial invoice (Spanish)
   ．Declaration of origin

Marketing Notice

1. Any natural or legal person offering for the first time a product of category IIa, IIb or III for distribution and/or use in Spain should contact the Spanish Agency for Medicines and Health Products.
   2.URL:
   https://sede.aemps.gob.es/en/procedimientos-y-servicios/tramites-mas-usados.html
   3.Notification content
   ．Identity data of natural/legal persons
   ．Product category
   ．The commercial name of the product in Spain and the commercial name of the product sold in the EU (if different from the first name)
   ．Product categories, types and models
   ．Product description and intended use
   ．Information about the manufacturer, manufacturing location and its authorized representative (if applicable)
   ．Identification number of the notified body for CE marking, application accessories and copy of CE certificate of conformity
   ．Notified body certified labels and instructions for use
   ．Labels and instructions for use (Spanish) for products to be sold in Spain
   ．Date of launch or entry into service in Spain
   ．Spanish dealer’s identity information

【參考連結】
https://www.boe.es/buscar/doc.php?id=BOE-A-2009-17606
https://sede.aemps.gob.es/en/procedimientos-y-servicios/tramites-mas-usados.html

HLF-TW-70
西班牙醫療器材審核機構，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：
CE認證

1. CE驗證是製造商或其授權代表確保並聲明產品符合CE型式檢驗規定。
2. 製造程序保證產品符合 CE 型式檢驗證書中所述的類型以及適用法令要求，且在開始製造之前，必須準備製造程序文件。
   3.對於無菌產品要確定無菌條件及其製造維護。
   4.製造商應承諾建立並維持最新的系統程序。
   5.所有產品應單獨檢驗，並應進行標準中定義的適當測試或同等測試，以驗證其符合檢驗證書中描述的類型（如適用）
   6.公告機構應在每個核准的產品上放置或安排其編號，並頒發與所進行的測試相對應的書面合格證書。
   7.製造商將以同質批次的形式展示製造的產品。
   8.從每批產品中隨機抽取樣本、單獨檢查。
   9.產品的統計控制將透過屬性和/或變數進行。
   10.製造商或其授權代表必須向國家當局提供該產品至少 5 年的期限，如果是可植入產品，則在最後一個產品製造完成後至少 15 年。

符合性聲明
1.適用於 IIa 類產品。
2.製造商應透過合格聲明確保並聲明 IIa 類產品是按照技術文件製造的，並符合要求法令。
3.機構進行的驗證將以 IIa 類產品與技術文件的符合性為目標。

CE certification

1. CE verification is when the manufacturer or its authorized representative ensures and declares that the product complies with CE type inspection regulations.
2. The manufacturing process ensures that the product conforms to the type described in the CE type examination certificate and applicable statutory requirements, and before starting manufacturing, manufacturing process documentation must be prepared.
3. For sterile products, the sterile conditions and manufacturing maintenance must be determined.
4. The manufacturer should commit to establishing and maintaining the latest system procedures.
5. All products shall be individually inspected and shall be subjected to appropriate tests defined in the standard or equivalent tests to verify that they conform to the type described in the inspection certificate (if applicable)
6. The notified body shall place or arrange its number on each approved product and issue a written certificate of conformity corresponding to the tests performed.
7. Manufacturers will display manufactured products in homogeneous batches.
8. Randomly select samples from each batch of products and inspect them individually.
9. Statistical control of the product will be carried out through attributes and/or variables.
10. The manufacturer or his authorized representative must make the product available to the national authorities for a period of at least 5 years, or in the case of implantable products, at least 15 years after the last product was manufactured.

Declaration of conformity

1. Applicable to Class IIa products.
2. The manufacturer should ensure and declare through a declaration of conformity that Class IIa products are manufactured in accordance with technical documents and comply with required regulations.
3. The verification conducted by the agency will target the conformity of Class IIa products with technical documentation.

【參考連結】
https://www.boe.es/buscar/doc.php?id=BOE-A-2009-17606

HLF-TW-75

HLF-TW-77

HLF-TW-80
外國子公司進口醫療器材後，如果委託西班牙的經銷商銷售，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 Spain 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：
無營業許可證。

產品安全
製造商應負起監督責任，但如果沒有這樣做的話，授權代表、進口商或分銷商，必須在得知以下事實後立即向西班牙藥品和保健品局發送通知，並告知糾正措施。
1.任何有缺陷的操作或產品特性或性能的改變，以及標籤或使用說明的任何不充分，可能導致或可能已經導致患者或健康狀況嚴重惡化。
2.與產品特性或性能相關的任何技術或健康性質的原因，促使製造商對同類產品採取系統性措施。

No business license.
Product Safety
The manufacturer shall assume the responsibility for supervision, but if this is not done, the authorized representative, importer or distributor must immediately send a notification to the Spanish Agency for Medicines and Health Products upon becoming aware of the following facts and inform them of corrective measures.

1. Any defective operation or alteration in the characteristics or performance of the product, as well as any inadequacy of the labeling or instructions for use, may cause or may have caused a serious deterioration of the patient or health condition.
2. Any technical or health reasons related to the characteristics or performance of the product prompt the manufacturer to take systematic measures against similar products.

【參考連結】
https://notificaps.aemps.es/enviotelematico/notificaps/notifica/inicio.do

HLF-TW-85

各國醫療器材登記法規問答集

联系我们：
Email：bcn4ww@evershinecpa.com
或
西班牙永輝BPO有限公司
Barcelona time zone:
Anna Wang, 說西班牙文中文和英文
或
China Time Zone:
聯絡人: 陳中成 Dale Chen 會計師/所長
手機：+886-933-920-199
skype: Daleccchen
wechat: Evershiinecpa
電話：+886-2-2717-0515 分機:100

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地址:104臺北市中山區長春路378號6樓
捷運文湖線南京復興站,兄弟大飯店附近
所長 Principal Partner:
陳中成 Dale C.C. Chen;
會計師 in 台灣+中國+英國/企管碩士+企管博士/台灣專利師;
CPA in Taiwan+China+UK/ MBA+DBA/ Patent Attorney in Taiwan;
Mobile: +86-139-1048-6278 in China ;
Mobile:+886-933920199 in Taipei;
Wechat ID: evershiinecpa ;
Line ID:evershinecpa;
Skype:daleccchen ;
Linkedin Address:  Dale Chen Linkedin

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永輝潛在可服務城市 (2個月籌備期)：
我們為IAPA會員所,總部在倫敦，全球300個會員所，員工約1萬人。
我們為LEA會員所,總部在美國芝加哥，全球600個會員所，員工約2萬8千人。
Evershine is local Partner of ADP Streamline® in Taiwan.
(版本:2022/03)

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