荷蘭醫療器材登記法規問題集
Email：ams4ww@evershinecpa.com
或
荷蘭永輝BPO有限公司
Amsterdam time zone:
Anna Wang, 說荷蘭文中文和英文
或
China Time Zone:
聯絡人: 陳中成 總經理 in 台+中+英;專利師;企管碩士+企管博士
Mobile: +886-933920199
in Taiwan; Mobile: +86-139-1048-6278
in China
TEL: +886-2-27170515 E100
;
Wechat id:evershiinecpa;
Line Id: evershinecpa
Skype: daleccchen
;
linkedin address:Dale Chen Linkedin
HLF-NL-10
請問荷蘭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 Kingdom of the Netherlands? 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：
在荷蘭，健康和青年護理檢查局(IGJ) 對醫療器材的安全性以及醫療保健提供者的安全使用進行監督，包含醫療技術的整個生命週期：
1.設計
2.市場介紹
3.選購
4.臨床使用
5.上市後監督 (PMS)
6.管理
7.退出
醫療器材是用於醫療保健部門診斷和治療的產品，或可以幫助預防或預測疾病/病症的產品。例如：
1.輪椅
2.乳房植入物
3.手術器材
4.起搏器
5.軟件
體外診斷 (IVD) 是一種單獨的醫療器材，用於檢查身體材料的樣本，例如：
1. 尿檢
2. 妊娠試驗
3. 血糖儀等
醫療器材根據風險進行分類，患者面臨的風險越大，檢查醫療器材是否會被允許進入市場的檢查就越嚴格，由低至高分成4類：
1. I：低風險醫療器材，例如繃帶。
2. IIa ：中度風險醫療器材，例如皮下注射針頭。
3. IIb ：中高風險醫療器材，例如麻醉機。
4. III ：與心臟、中樞循環系統或中樞神經系統直接接觸的醫療器材，例如心導管和避孕線圈。
In the Netherlands, the Health and Youth Care Inspectorate (IGJ) oversees the safety of medical devices and their safe use by healthcare providers, covering the entire life cycle of medical technology:
1. Design
2. Market introduction
3. Shopping
4. Clinical use
5. Post-market surveillance (PMS)
6. Management
7. Exit
A medical device is a product that is used for diagnosis and treatment in the healthcare sector or that can help prevent or predict disease/condition. E.g:
1. Wheelchair
2. Breast Implants
3. Surgical device
4. Pacemaker
5. Software
In vitro diagnostic (IVD) is a separate medical device used to examine samples of bodily materials such as:
1. Urine test
2. Pregnancy test
3. Blood glucose meter, etc.
Medical devices are classified according to risk. The greater the risk to the patient, the stricter the inspection to check whether the medical device will be allowed to enter the market. It is divided into 4 categories from the lowest to the highest:
1. I: Low risk medical devices, such as bandages.
2. IIa: Moderate risk medical devices, such as hypodermic needles.
3. IIb: Medium to high risk medical device, such as anesthesia machines.
4. III: Medical devices that come into direct contact with the heart, central circulatory system or central nervous system, such as cardiac catheters and contraceptive coils.
【參考連結】
https://business.gov.nl/regulation/medical-devices/
HLF-NL-20
外國公司要到荷蘭銷售醫療器材，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 Kingdom of the Netherlands, 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：
無須申請營業特許證。
No business license is required.
【參考連結】
https://business.gov.nl/regulation/medical-devices/
HLF-NL-25
假如需要辦理，請問荷蘭有專業服務公司可以協助辦理醫療器材公司營業許可證？
Evershine RD：
無須申請營業特許證。
HLF-NL-30
外國公司要到荷蘭銷售醫療器材，可以指派荷蘭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 Kingdom of the Netherlands, can it assign a Kingdom of the Netherlands 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。在荷蘭銷售醫療器材，需要當地的製造商或授權當地代表完成註冊，才得以投放到市場。
授權代表
1. 如果製造商不在成員國境內，則只有在製造商指定唯一授權代表的情況下，設備才能投放到歐盟市場。
2. 指定構成授權代表的授權，只有在授權代表書面接受時才有效，並且至少對同一通用器材組的所有器材有效。
3. 授權代表應執行其與製造商約定的任務規定的任務。授權代表應根據要求向主管當局提供授權書副本。
授權應要求且製造商應允許授權代表至少執行以下與其涵蓋的設備有關的任務：
．驗證是否已起草歐盟符合性聲明和技術文件，並且在適用的情況下，製造商是否已執行適當的合格評定程序。
．保留技術文件副本、歐盟符合性聲明以及相關證書（如適用）的副本，包括任何修改和補充，以供主管當局使用。
．遵守註冊義務，並核實製造商已遵守註冊義務。
．以相關成員國確定的歐盟官方語言向該主管當局提供證明器材符合性所需的所有信息和文件。
．將授權代表註冊營業地所在成員國的主管當局的任何請求轉發給製造商，以獲取樣品或訪問設備，並驗證主管當局是否收到樣品或有權訪問設備。
．與主管當局合作採取任何預防或糾正措施，以消除或在不可能的情況下減輕器材帶來的風險。
．立即通知製造商有關醫療保健專業人員、患者和用戶關於與他們指定使用的設備相關的可疑事件的投訴和報告。
．如果製造商的行為違反本法規下的義務，則終止授權。
．如果製造商未在成員國設立公司，則授權代表應對有缺陷的設備承擔相同的法律責任。
荷蘭健康和青年護理檢查局(IGJ)醫療器材註冊(Farmatec)
1. 申請人：在荷蘭成立的製造商或其授權代表。
2. 需註冊的醫療器材：
．Ⅰ類醫療器材
．定制醫療器材
．體外診斷 (IVD)（所有風險等級）
3. 網頁：https://english.farmatec.nl/
4.文件要求
．符合性聲明 (DoC)：製造商的名稱和地址、產品遵守的法規、簽發日期和主管人員的簽名、產品標識、授權代表的姓名和地址(如適用)、生產地點(如果適用)。
．CE證書：製造商的名稱和地址、產品遵守的法規、簽發日期和主管人員的簽名、產品標識、生產地點(如果適用)
5.備註：
．若為第一次註冊產品，須先完成註冊公司資料。
．CE 證書必須由指定機構頒發
產品責任
1. 醫療器材的製造商或授權代表有法律義務在荷蘭向健康和青年護理檢查局(IGJ)報告涉及任何設備的嚴重事件，且必須將與醫療器材安全相關的糾正措施通知健康和青年護理檢查局(IGJ)，包含報告嚴重事件和糾正措施 (FSCA)。
2. 報告方式：填寫電子表格並保存，然後表單作為附件添加到電子郵件中，發送電子郵件至：meldpunt@igj.nl。
3. 報告項目：
．一般召回
．設計變更
．更改使用說明
．更改產品包裝
4. 表格：
．糾正措施表現場安全糾正措施 (FSCA)
．安全通知表現場安全通知 (FSN)
．現場安全通知的澄清問題和答案
Yes. Medical devices sold in the Netherlands must be registered with the local manufacturer or authorized local representative before they can be placed on the market.
Authorized representative
1. If the manufacturer is outside the territory of a member state, the device may only be placed on the EU market if the manufacturer appoints a sole authorised representative.
2. The authorization designated to constitute an authorized representative is valid only when accepted in writing by the authorized representative, and is valid for at least all devices of the same general device group.
3. The authorized representative shall perform the tasks specified in the tasks agreed upon with the manufacturer. The authorised representative shall provide the competent authority with a copy of the power of attorney upon request. Authorization shall be required and the manufacturer shall allow an authorized representative to perform at least the following tasks in relation to the device it covers:
．Verify that the EU Declaration of Conformity and Technical File have been drafted and, where applicable, that the manufacturer has carried out the appropriate conformity assessment procedures.
．Keep copies of the technical documentation, the EU Declaration of Conformity and, if applicable, the relevant certificates, including any modifications and additions, for the use of the competent authorities.
．Comply with registration obligations and verify that the manufacturer has complied with registration obligations.
．Provide this competent authority with all the information and documents required to demonstrate the conformity of the device in the official EU language determined by the Member State concerned.
．Forward any request by the competent authority of the Member State where the authorized representative has its registered place of business to the manufacturer to obtain samples or access the device and to verify whether the competent authority has received the samples or has the right to access the device.
．Take any preventive or corrective action in cooperation with the competent authority to eliminate or, where unlikely, mitigate the risks posed by the device.
．Immediately notify manufacturers of complaints and reports of healthcare professionals, patients, and users of suspicious incidents related to the devices they are designated for use.
．The authorisation is terminated if the manufacturer acts in breach of its obligations under this Regulation.
．If the manufacturer does not set up a company in a member state, the authorised representative shall bear the same legal liability for defective device.
Netherlands Health and Youth Care Inspectorate (IGJ) Medical Device Registration (Farmatec)
1. Applicant: The manufacturer established in the Netherlands or its authorized representative.
2. Medical devices to be registered:
．Class I medical devices
．Custom Medical Devices
．In Vitro Diagnostics (IVD) (all risk classes)
3. URL: https://english.farmatec.nl/
4. Documentation requirements
．Declaration of Conformity (DoC): Manufacturer’s name and address, regulations to which the product complies, date of issue and signature of the competent person, product identification, name and address of authorized representative (if applicable), location of manufacture (if applicable).
．CE certificate: Manufacturer’s name and address, regulations to which the product complies, date of issue and signature of supervisor, product identification, production location (if applicable)
5. Remarks:
．If it is the first time to register a product, you must complete the registered company information first.
．CE certificate must be issued by a designated body
Product Liability
1. The manufacturer or authorised representative of a medical device is legally obliged to report serious incidents involving any device to the Health and Youth Care Inspection Agency (IGJ) in the Netherlands and must notify the Health and Youth Care Inspection of corrective actions related to the safety of the medical device Bureau (IGJ), which includes reporting of serious incidents and corrective actions (FSCA).
2. Report: Fill out the spreadsheet and save it, then add the form as an attachment to an email, send an email to: meldpunt@igj.nl.
3. Report items:
．General recall
．Design changes
．Change instructions for use
．Change product packaging
4. Forms:
．Corrective Action Table Site Safety Corrective Action (FSCA)
．Security Notification Table Field Security Notification (FSN)
．Clarification Questions and Answers for Field Safety Notifications
【參考連結】
https://business.gov.nl/regulation/medical-devices/
HLF-NL-35
HLF-NL-40
外國公司銷售到荷蘭醫療器材本身，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 Kingdom of the Netherlands? 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，須以荷蘭或歐盟成員國之公司身分於歐盟網站完成 (EUDAMED醫療器材)註冊，以及製造商或授權當地代表於荷蘭健康和青年護理檢查局(IGJ)完成醫療器材註冊(Farmatec)
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)
．識別設備型號
．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
．嚴重警告或禁忌症
．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。
．質量等級證書：歐盟質量管理體系證書、歐盟質量保證證書、 歐盟生產質量保證證書。
4.臨床調查和性能研究(開發中)
5.警惕和上市後監督(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。
荷蘭健康和青年護理檢查局(IGJ)醫療器材註冊(Farmatec)
1. 申請人：在荷蘭成立的製造商或其授權代表。
2. 需註冊的醫療器材：
．Ⅰ類醫療器材
．定制醫療器材
．體外診斷 (IVD)（所有風險等級）
3. 網頁：https://english.farmatec.nl/
4.文件要求
．符合性聲明 (DoC)：製造商的名稱和地址、產品遵守的法規、簽發日期和主管人員的簽名、產品標識、授權代表的姓名和地址(如適用)、生產地點(如果適用)。
．CE證書：製造商的名稱和地址、產品遵守的法規、簽發日期和主管人員的簽名、產品標識、生產地點(如果適用)
5.備註：
．若為第一次註冊產品，須先完成註冊公司資料。
．CE 證書必須由指定機構頒發
標籤、使用說明和語言的要求
1.每個醫療設備和每個體外診斷設備 (IVD) 都必須附有清晰的標籤、使用說明，並在適用的情況下附有射頻識別（RFID）或條形碼。
2.標籤和使用說明中的信息必須根據未來用戶的培訓、知識進行調整。該信息也必須在製造商的網站上提供。
3.製造商提供的信息應採用國際認可的符號形式。
4.標籤上要求的信息應在設備本身上提供，並且必須不可磨滅、清晰易讀，如果因為包裝太小而不可行或不合適，則可能顯示部分信息。
5.需要告知用戶和/或其他人的殘餘風險應作為限制、禁忌症、預防措施或警告包含在製造商提供的信息中。
6. 標籤應包含以下所有內容：
．裝置的名稱/商品名稱。
．用戶識別必需的詳細信息、包裝內容以及器材的預期用途。
．製造商的名稱、註冊商號或註冊商標及其註冊營業地點的地址。
．如果製造商的註冊營業地點在歐盟以外，須標示授權代表的姓名和授權代表的註冊營業地點的地址。
．藥用物質，包括人類血液或血漿衍生物(如果適用) 。
．人類來源的組織或細胞，或其衍生物(如果適用) 。
．動物來源的組織或細胞，或其衍生物(如果適用) 。
．設備的批號或序列號，前面有 LOT NUMBER 或 SERIAL NUMBER 字樣或等效符號，視情況而定。
．UDI承運人。
．明確說明安全使用或植入器材的時間限制，在相關的情況下至少以年和月表示。如果可以安全使用則為製造日期，該製造日期可以作為批號或序列號的一部分包含在內，前提是該日期可以清楚地被識別。
．適用的任何特殊儲存和/或處理條件的說明。
．如果器材是無菌供貨的，說明其無菌狀態和滅菌方法。
．警告或預防措施。
．無菌器材的包裝信息：無菌包裝的標誌、聲明、消毒方法、製造商的名稱和地址、設備的描述、專門用於臨床研究(如果適用)、定制設備(如果適用)、製造的月份和年份、明確指示使用或植入的時間限制、使用說明、檢查是否在使用前損壞或無意打開的說明。
7. 使用說明應包含以下所有內容：
．器材的預期用途，並明確說明適應症、禁忌症、患者目標群體和預期用戶。
．預期的臨床益處 (如果適用)。
．安全性和臨床表現總結(如果適用)。
．裝置的性能特徵。
．允許醫療保健專業人員驗證設備是否合適並選擇相應軟件和附件的信息(如果適用)。
．任何殘餘風險、禁忌症和任何不良副作用，包括在這方面向患者傳達的信息。
．用戶正確使用設備所需的規格，例如如果該設備具有測量功能，其聲稱的準確度。
．在設備準備好使用之前或使用期間對設備進行的任何準備處理或處理的詳細信息，例如滅菌、最終組裝、校準等，包括確保患者安全所需的消毒水平和所有可用方法達到這些消毒水平。
．對設備用戶和/或其他人的特殊設施、特殊培訓或特殊資格的任何．要求。
．驗證設備是否正確安裝並準備好按照製造商的預期安全運行所需的信息。
．如果設備是無菌供應的，在使用前無菌包裝損壞或無意打開時的說明。
．如果設備以非無菌形式提供，目的是在使用前對其進行滅菌，則適當的滅菌說明。
．如果器材是可重複使用的，關於允許重複使用的適當過程的信息，包括清潔、消毒、包裝，以及在適當情況下，適用於放置器材的成員國或成員國的經驗證的再滅菌方法在市場上。應提供信息以識別何時不應再使用該設備，例如：材料退化跡像或最大允許重複使用次數。
．設備只有在製造商負責修復以符合一般安全和性能要求時才能重複使用(如果適用)。
．如果設備標有其為一次性使用的指示，則有關製造商已知的已知特性和技術因素的信息，如果該設備被重複使用，可能會造成風險。該信息應基於製造商風險管理文件的特定部分，其中應詳細說明此類特徵和技術因素。
．與其他設備和/或通用設備一起使用的設備：識別此類裝置或設備的信息，以獲得安全組合、設備和設備組合的任何已知限制的信息。
．關於發射輻射的性質、類型和適當情況下的強度和分佈的詳細信息。
．在使用設備期間保護患者、用戶或其他人免受意外輻射的方法。
．如果器材由擬引入人體的物質或物質組合組成，並被人體吸收或局部分散在人體中，在適當的情況下，警告和預防措施與以下內容有關器材及其代謝產物與其他器材、藥品和其他物質相互作用的一般概況，以及與過量服用有關的禁忌症、不良副作用和風險。
．對於可植入設備，關於患者可能接觸的材料和物質的總體定性和定量信息。
．為便於安全處置設備、其附件和與之一起使用的耗材（如有）而採取的警告或預防措施。
．對於供非專業人士使用的設備，用戶應諮詢醫療保健專業人員的情況。
．通知用戶和/或患者，任何與設備有關的嚴重事件都應報告給製造商和用戶和/或患者所在成員國的主管當局。
．對於包含電子可編程系統的設備，包括軟件或本身就是設備的軟件，有關硬件、IT網路特性和IT安全措施的最低要求，包括防止未經授權的訪問。
8.在荷蘭，標籤和使用說明上的信息必須使用荷蘭語，應使用適合潛在用戶的教育和知識的語言。如果可能，製造商還應以符號形式提供信息。如果確定醫療設備和 IVD 將僅由精通英語的醫療保健專業人員使用，可以僅以英語提供信息。
9.製造商的地址必須在標籤上註明。如果製造商來自歐盟以外，則（授權）代表的地址也必須在標籤、包裝或使用說明中。
Yes. It is necessary to complete the registration on the EU website (EUDAMED medical device) as a company in the Netherlands or an EU member state, and the manufacturer or authorized local representative to complete the medical device registration (Farmatec) at the Netherlands Health and Youth Care Inspection Agency (IGJ).
EU (EUDAMED) registration process
1. Role Registration (Manufacturer / Authorized Representative / Importer)
．Company name / Applicant name
．Contact phone number, Email
．Country, city, street, postal code, etc.
2.UDI/device registration
．Manufacturer’s name, address
．Risk class
．Measuring function (yes/no)
．Reusable surgical instruments (yes/no)
．Active device (yes/no)
．Identify the device model
．Technical file or certificate/declaration of conformity
．Number of devices
．Use unit
．Clinical scale
．Additional product descriptions
．Disposable (yes/no)
．Maximum number of repetitions
．Does it need to be sterilized?
．Latex-containing (yes/no)
．CMR/endocrine disruptor
．Severe warnings or contraindications
．Medical Device Nomenclature (CND) codes and more
3. Certification and Notified Body
．Product Category Certificate: EU Type Inspection Certificate, EU Technical Document Certificate, EU Product Verification Certificate.
．Quality grade certificates: EU quality management system certificate, EU quality assurance certificate, EU production quality assurance certificate.
4. Clinical investigations and performance studies (in development)
5. Vigilance and post-market surveillance (in development)
6. Market surveillance (under development)
7. EU-issued licenses are valid for 5 years.
Netherlands Health and Youth Care Inspectorate (IGJ) Medical Device Registration (Farmatec)
1. Applicant: The manufacturer established in the Netherlands or its authorized representative.
2. Medical devices to be registered:
．Class I medical devices
．Custom Medical Devices
．In Vitro Diagnostics (IVD) (all risk classes)
3. URL: https://english.farmatec.nl/
4. Documentation requirements
．Declaration of Conformity (DoC): Manufacturer’s name and address, regulations to which the product complies, date of issue and signature of the competent person, product identification, name and address of authorized representative (if applicable), location of manufacture (if applicable).
．CE certificate: Manufacturer’s name and address, regulations to which the product complies, date of issue and signature of supervisor, product identification, production location (if applicable)
5. Remarks:
．If it is the first time to register a product, you must complete the registered company information first.
．CE certificate must be issued by a designated body
Labeling, Instructions for Use and Language Requirements
1. Each medical device and each in vitro diagnostic device (IVD) must be clearly labelled, instructions for use, and, where applicable, radio frequency identification (RFID) or barcodes.
2. The information in the labels and instructions for use must be adjusted based on the training and knowledge of future users. This information must also be provided on the manufacturer’s website.
3. The information provided by the manufacturer should be in the form of an internationally recognized symbol.
4. The information required on the label should be provided on the device itself and must be indelible, legible, and may be partially displayed if the package is too small to be feasible or appropriate.
5. Residual risks that need to be communicated to users and/or others should be included in the information provided by the manufacturer as limitations, contraindications, precautions or warnings.
6. Labels should contain all of the following:
．The name of the device/trade name.
．User identification of the necessary details, package contents and intended use of the device.
．The manufacturer’s name, registered trade name or registered trademark and the address of its registered place of business.
．If the manufacturer’s registered place of business is outside the EU, the name of the authorized representative and the address of the authorized representative’s registered place of business must be indicated.
．Medicinal substances, including derivatives of human blood or plasma (if applicable).
．Tissues or cells of human origin, or derivatives thereof (if applicable).
．Tissues or cells of animal origin, or derivatives thereof (if applicable).
．The lot or serial number of the device, preceded by the words LOT NUMBER or SERIAL NUMBER or equivalent, as appropriate.
．UDI carrier.
．Clearly state the time limit for the safe use or implantation of the device, expressed in at least years and months where relevant. The date of manufacture if it is safe to use, which may be included as part of the batch or serial number, provided that the date can be clearly identified.
．A statement of any special storage and/or handling conditions that apply.
．If device is supplied sterile, state its sterile state and method of sterilization.
．Warning or precautionary measure.
．Packaging Information for Sterile Devices: Sterile packaging markings, declarations, method of sterilization, manufacturer’s name and address, description of the device, dedicated to clinical research (if applicable), custom device (if applicable), month and year of manufacture, Clearly indicate time limits for use or implantation, instructions for use, instructions to check for damage or unintentional opening prior to use.
7. Instructions for use shall include all of the following:
．The intended use of the device, with a clear indication of indications, contraindications, target patient groups and intended users.
．Expected clinical benefit (if applicable).
．Summary of safety and clinical presentation (if applicable).
．Performance characteristics of the device.
．Information that allows healthcare professionals to verify the suitability of the device and select appropriate software and accessories, if applicable.
．Any residual risks, contraindications, and any adverse side effects, including messages communicated to patients in this regard.
．Specifications required by the user to use the device properly, such as its claimed accuracy if the device has a measurement capability.
．If the device is supplied sterile, instructions if the sterile packaging is damaged or unintentionally opened prior to use.
．Appropriate sterilization instructions if the device is provided in a non-sterile form with the intention of sterilizing it prior to use.
．If the device is reusable, information on the appropriate processes to allow reuse, including cleaning, sterilization, packaging, and, where appropriate, validated resterilization methods for the Member State in which the device is placed or the Member State in which the device is placed on the market superior. Information should be provided to identify when the device should no longer be used, e.g. signs of material degradation or maximum allowable number of reuses.
．Device may only be reused (if applicable) if it is repaired by the manufacturer to meet general safety and performance requirements.
．If the device is marked with an indication that it is for single use, information about known characteristics and technical factors known to the manufacturer that could pose a risk if the device is reused. This information should be based on a specific section of the manufacturer’s risk management documentation, which should detail such characteristics and technical factors.
．Device used with other device and/or general purpose device: Information identifying such devices or device for information on security combinations, device and any known limitations of combinations of device.
．Detailed information on the nature, type and where appropriate intensity and distribution of emitted radiation.
．Methods of protecting patients, users, or others from accidental radiation during device use.
．If the device consists of a substance or combination of substances intended for introduction into the human body and is absorbed or locally dispersed in the human body, where appropriate, warnings and precautions related to the device and its metabolites and other devices, medicines and other General profile of substance interactions, as well as contraindications, adverse side effects and risks associated with overdose.
．For implantable devices, general qualitative and quantitative information about materials and substances to which the patient may be exposed.
．Warnings or precautions for the safe disposal of the device, its accessories and consumables (if any) used with it.
．For devices intended for non-professional use, users should consult a healthcare professional.
．Inform the user and/or the patient that any serious event related to the device should be reported to the competent authority of the Member State in which the manufacturer and the user and/or the patient are located.
．Minimum requirements for hardware, IT network characteristics and IT security measures, including protection against unauthorized access, for device incorporating electronically programmable systems, including software or software that is itself device.
8. In the Netherlands, information on labels and directions for use must be in Dutch, in a language appropriate to the education and knowledge of the potential user. If possible, the manufacturer should also provide information in symbolic form. Information may be provided in English only if it is determined that the medical device and IVD will only be used by health care professionals who are proficient in English.
9. The address of the manufacturer must be indicated on the label. If the manufacturer is from outside the EU, the (authorized) representative’s address must also be on the label, packaging or instructions for use.
【參考連結】
https://ec.europa.eu/tools/eudamed/#/screen/home
https://business.gov.nl/regulation/medical-devices/
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX%3A02017R0745%2D20200424&from=EN
HLF-NL-45
HLF-NL-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：
需以荷蘭或歐盟成員國之公司身分於歐盟網站完成 (EUDAMED醫療器材)註冊，以及製造商或授權當地代表於荷蘭健康和青年護理檢查局(IGJ)完成醫療器材註冊(Farmatec)
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)
．識別設備型號
．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
．嚴重警告或禁忌症
．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。
．質量等級證書：歐盟質量管理體系證書、歐盟質量保證證書、 歐盟生產質量保證證書。
4.臨床調查和性能研究(開發中)
5.警惕和上市後監督(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。
荷蘭健康和青年護理檢查局(IGJ)醫療器材註冊(Farmatec)
1. 申請人：在荷蘭成立的製造商或其授權代表。
2. 需註冊的醫療器材：
．Ⅰ類醫療器材
．定制醫療器材
．體外診斷 (IVD)（所有風險等級）
3. 網頁：https://english.farmatec.nl/
4.文件要求
．符合性聲明 (DoC)：製造商的名稱和地址、產品遵守的法規、簽發日期和主管人員的簽名、產品標識、授權代表的姓名和地址(如適用)、生產地點(如果適用)。
．CE證書：製造商的名稱和地址、產品遵守的法規、簽發日期和主管人員的簽名、產品標識、生產地點(如果適用)
5.備註：
．若為第一次註冊產品，須先完成註冊公司資料。
．CE 證書必須由指定機構頒發
標籤、使用說明和語言的要求
1.每個醫療設備和每個體外診斷設備 (IVD) 都必須附有清晰的標籤、使用說明，並在適用的情況下附有射頻識別（RFID）或條形碼。
2.標籤和使用說明中的信息必須根據未來用戶的培訓、知識進行調整。該信息也必須在製造商的網站上提供。
3.製造商提供的信息應採用國際認可的符號形式。
4.標籤上要求的信息應在設備本身上提供，並且必須不可磨滅、清晰易讀，如果因為包裝太小而不可行或不合適，則可能顯示部分信息。
5.需要告知用戶和/或其他人的殘餘風險應作為限制、禁忌症、預防措施或警告包含在製造商提供的信息中。
6. 標籤應包含以下所有內容：
．裝置的名稱/商品名稱。
．用戶識別必需的詳細信息、包裝內容以及器材的預期用途。
．製造商的名稱、註冊商號或註冊商標及其註冊營業地點的地址。
．如果製造商的註冊營業地點在歐盟以外，須標示授權代表的姓名和授權代表的註冊營業地點的地址。
．藥用物質，包括人類血液或血漿衍生物(如果適用) 。
．人類來源的組織或細胞，或其衍生物(如果適用) 。
．動物來源的組織或細胞，或其衍生物(如果適用) 。
．設備的批號或序列號，前面有 LOT NUMBER 或 SERIAL NUMBER 字樣或等效符號，視情況而定。
．UDI承運人。
．明確說明安全使用或植入器材的時間限制，在相關的情況下至少以年和月表示。如果可以安全使用則為製造日期，該製造日期可以作為批號或序列號的一部分包含在內，前提是該日期可以清楚地被識別。
．適用的任何特殊儲存和/或處理條件的說明。
．如果器材是無菌供貨的，說明其無菌狀態和滅菌方法。
．警告或預防措施。
．無菌器材的包裝信息：無菌包裝的標誌、聲明、消毒方法、製造商的名稱和地址、設備的描述、專門用於臨床研究(如果適用)、定制設備(如果適用)、製造的月份和年份、明確指示使用或植入的時間限制、使用說明、檢查是否在使用前損壞或無意打開的說明。
7. 使用說明應包含以下所有內容：
．器材的預期用途，並明確說明適應症、禁忌症、患者目標群體和預期用戶。
．預期的臨床益處 (如果適用)。
．安全性和臨床表現總結(如果適用)。
．裝置的性能特徵。
．允許醫療保健專業人員驗證設備是否合適並選擇相應軟件和附件的信息(如果適用)。
．任何殘餘風險、禁忌症和任何不良副作用，包括在這方面向患者傳達的信息。
．用戶正確使用設備所需的規格，例如如果該設備具有測量功能，其聲稱的準確度。
．在設備準備好使用之前或使用期間對設備進行的任何準備處理或處理的詳細信息，例如滅菌、最終組裝、校準等，包括確保患者安全所需的消毒水平和所有可用方法達到這些消毒水平。
．對設備用戶和/或其他人的特殊設施、特殊培訓或特殊資格的任何．要求。
．驗證設備是否正確安裝並準備好按照製造商的預期安全運行所需的信息。
．如果設備是無菌供應的，在使用前無菌包裝損壞或無意打開時的說明。
．如果設備以非無菌形式提供，目的是在使用前對其進行滅菌，則適當的滅菌說明。
．如果器材是可重複使用的，關於允許重複使用的適當過程的信息，包括清潔、消毒、包裝，以及在適當情況下，適用於放置器材的成員國或成員國的經驗證的再滅菌方法在市場上。應提供信息以識別何時不應再使用該設備，例如：材料退化跡像或最大允許重複使用次數。
．設備只有在製造商負責修復以符合一般安全和性能要求時才能重複使用(如果適用)。
．如果設備標有其為一次性使用的指示，則有關製造商已知的已知特性和技術因素的信息，如果該設備被重複使用，可能會造成風險。
該信息應基於製造商風險管理文件的特定部分，其中應詳細說明此類特徵和技術因素。
．與其他設備和/或通用設備一起使用的設備：識別此類裝置或設備的信息，以獲得安全組合、設備和設備組合的任何已知限制的信息。
．關於發射輻射的性質、類型和適當情況下的強度和分佈的詳細信息。
．在使用設備期間保護患者、用戶或其他人免受意外輻射的方法。
．如果器材由擬引入人體的物質或物質組合組成，並被人體吸收或局部分散在人體中，在適當的情況下，警告和預防措施與以下內容有關器材及其代謝產物與其他器材、藥品和其他物質相互作用的一般概況，以及與過量服用有關的禁忌症、不良副作用和風險。
．對於可植入設備，關於患者可能接觸的材料和物質的總體定性和定量信息。
．為便於安全處置設備、其附件和與之一起使用的耗材（如有）而採取的警告或預防措施。
．對於供非專業人士使用的設備，用戶應諮詢醫療保健專業人員的情況。
．通知用戶和/或患者，任何與設備有關的嚴重事件都應報告給製造商和用戶和/或患者所在成員國的主管當局。
．對於包含電子可編程系統的設備，包括軟件或本身就是設備的軟件，有關硬件、IT網路特性和IT安全措施的最低要求，包括防止未經授權的訪問。
8.在荷蘭，標籤和使用說明上的信息必須使用荷蘭語，應使用適合潛在用戶的教育和知識的語言。如果可能，製造商還應以符號形式提供信息。如果確定醫療設備和 IVD 將僅由精通英語的醫療保健專業人員使用，可以僅以英語提供信息。
9.製造商的地址必須在標籤上註明。如果製造商來自歐盟以外，則（授權）代表的地址也必須在標籤、包裝或使用說明中。
It is necessary to complete the registration on the EU website (EUDAMED medical device) as a company in the Netherlands or an EU member state, and the manufacturer or authorized local representative to complete the medical device registration (Farmatec) at the Netherlands Health and Youth Care Inspection Agency (IGJ).
EU (EUDAMED) registration process
1. Role Registration (Manufacturer / Authorized Representative / Importer)
．Company name / Applicant name
．Contact phone number, Email
．Country, city, street, postal code, etc.
2.UDI/device registration
．Manufacturer’s name, address
．Risk class
．Measuring function (yes/no)
．Reusable surgical instruments (yes/no)
．Active device (yes/no)
．Identify the device model
．Technical file or certificate/declaration of conformity
．Number of devices
．Use unit
．Clinical scale
．Additional product descriptions
．Disposable (yes/no)
．Maximum number of repetitions
．Does it need to be sterilized?
．Latex-containing (yes/no)
．CMR/endocrine disruptor
．Severe warnings or contraindications
．Medical Device Nomenclature (CND) codes and more
3. Certification and Notified Body
．Product Category Certificate: EU Type Inspection Certificate, EU Technical Document Certificate, EU Product Verification Certificate.
．Quality grade certificates: EU quality management system certificate, EU quality assurance certificate, EU production quality assurance certificate.
4. Clinical investigations and performance studies (in development)
5. Vigilance and post-market surveillance (in development)
6. Market surveillance (under development)
7. EU-issued licenses are valid for 5 years.
Netherlands Health and Youth Care Inspectorate (IGJ) Medical Device Registration (Farmatec)
1. Applicant: The manufacturer established in the Netherlands or its authorized representative.
2. Medical devices to be registered:
．Class I medical devices
．Custom Medical Devices
．In Vitro Diagnostics (IVD) (all risk classes)
3. URL: https://english.farmatec.nl/
4. Documentation requirements
．Declaration of Conformity (DoC): Manufacturer’s name and address, regulations to which the product complies, date of issue and signature of the competent person, product identification, name and address of authorized representative (if applicable), location of manufacture (if applicable).
．CE certificate: Manufacturer’s name and address, regulations to which the product complies, date of issue and signature of supervisor, product identification, production location (if applicable)
5. Remarks:
．If it is the first time to register a product, you must complete the registered company information first.
．CE certificate must be issued by a designated body
Labeling, Instructions for Use and Language Requirements
1. Each medical device and each in vitro diagnostic device (IVD) must be clearly labelled, instructions for use, and, where applicable, radio frequency identification (RFID) or barcodes.
2. The information in the labels and instructions for use must be adjusted based on the training and knowledge of future users. This information must also be provided on the manufacturer’s website.
3. The information provided by the manufacturer should be in the form of an internationally recognized symbol.
4. The information required on the label should be provided on the device itself and must be indelible, legible, and may be partially displayed if the package is too small to be feasible or appropriate.
5. Residual risks that need to be communicated to users and/or others should be included in the information provided by the manufacturer as limitations, contraindications, precautions or warnings.
6. Labels should contain all of the following:
．The name of the device/trade name.
．User identification of the necessary details, package contents and intended use of the device.
．The manufacturer’s name, registered trade name or registered trademark and the address of its registered place of business.
．If the manufacturer’s registered place of business is outside the EU, the name of the authorized representative and the address of the authorized representative’s registered place of business must be indicated.
．Medicinal substances, including derivatives of human blood or plasma (if applicable).
．Tissues or cells of human origin, or derivatives thereof (if applicable).
．Tissues or cells of animal origin, or derivatives thereof (if applicable).
．The lot or serial number of the device, preceded by the words LOT NUMBER or SERIAL NUMBER or equivalent, as appropriate.
．UDI carrier.
．Clearly state the time limit for the safe use or implantation of the device, expressed in at least years and months where relevant. The date of manufacture if it is safe to use, which may be included as part of the batch or serial number, provided that the date can be clearly identified.
．A statement of any special storage and/or handling conditions that apply.
．If device is supplied sterile, state its sterile state and method of sterilization.
．Warning or precautionary measure.
．Packaging Information for Sterile Devices: Sterile packaging markings, declarations, method of sterilization, manufacturer’s name and address, description of the device, dedicated to clinical research (if applicable), custom device (if applicable), month and year of manufacture, Clearly indicate time limits for use or implantation, instructions for use, instructions to check for damage or unintentional opening prior to use.
7. Instructions for use shall include all of the following:
．The intended use of the device, with a clear indication of indications, contraindications, target patient groups and intended users.
．Expected clinical benefit (if applicable).
．Summary of safety and clinical presentation (if applicable).
．Performance characteristics of the device.
．Information that allows healthcare professionals to verify the suitability of the device and select appropriate software and accessories, if applicable.
．Any residual risks, contraindications, and any adverse side effects, including messages communicated to patients in this regard.
．Specifications required by the user to use the device properly, such as its claimed accuracy if the device has a measurement capability.
．If the device is supplied sterile, instructions if the sterile packaging is damaged or unintentionally opened prior to use.
．Appropriate sterilization instructions if the device is provided in a non-sterile form with the intention of sterilizing it prior to use.
．If the device is reusable, information on the appropriate processes to allow reuse, including cleaning, sterilization, packaging, and, where appropriate, validated resterilization methods for the Member State in which the device is placed or the Member State in which the device is placed on the market superior. Information should be provided to identify when the device should no longer be used, e.g. signs of material degradation or maximum allowable number of reuses.
．Device may only be reused (if applicable) if it is repaired by the manufacturer to meet general safety and performance requirements.
．If the device is marked with an indication that it is for single use, information about known characteristics and technical factors known to the manufacturer that could pose a risk if the device is reused. This information should be based on a specific section of the manufacturer’s risk management documentation, which should detail such characteristics and technical factors.
．Device used with other device and/or general purpose device: Information identifying such devices or device for information on security combinations, device and any known limitations of combinations of device.
．Detailed information on the nature, type and where appropriate intensity and distribution of emitted radiation.
．Methods of protecting patients, users, or others from accidental radiation during device use.
．If the device consists of a substance or combination of substances intended for introduction into the human body and is absorbed or locally dispersed in the human body, where appropriate, warnings and precautions related to the device and its metabolites and other devices, medicines and other General profile of substance interactions, as well as contraindications, adverse side effects and risks associated with overdose.
．For implantable devices, general qualitative and quantitative information about materials and substances to which the patient may be exposed.
．Warnings or precautions for the safe disposal of the device, its accessories and consumables (if any) used with it.
．For devices intended for non-professional use, users should consult a healthcare professional.
．Inform the user and/or the patient that any serious event related to the device should be reported to the competent authority of the Member State in which the manufacturer and the user and/or the patient are located.
．Minimum requirements for hardware, IT network characteristics and IT security measures, including protection against unauthorized access, for device incorporating electronically programmable systems, including software or software that is itself device.
8. In the Netherlands, information on labels and directions for use must be in Dutch, in a language appropriate to the education and knowledge of the potential user. If possible, the manufacturer should also provide information in symbolic form. Information may be provided in English only if it is determined that the medical device and IVD will only be used by health care professionals who are proficient in English.
9. The address of the manufacturer must be indicated on the label. If the manufacturer is from outside the EU, the (authorized) representative’s address must also be on the label, packaging or instructions for use.
【參考連結】
https://ec.europa.eu/tools/eudamed/#/screen/home
https://business.gov.nl/regulation/medical-devices/
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX%3A02017R0745%2D20200424&from=EN
HLF-NL-55
HLF-NL-60
經過核准登記的醫療器材，進口到荷蘭要檢附什麼文件？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 Kingdom of the Netherlands?
What is the procedure? Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?
Evershine RD：
貼有 CE 認證標籤的產品可在所有歐洲經濟共同體 (簡稱 EEC) 會員國國內自由販售，不需經過其他國家產品檢測。
歐盟以外地區製造的貨品必須具備完整的海關申報書，才能在歐盟市場內自由販賣。
希望進行貿易的企業和個人在必須在所有海關程序中使用經濟經營者註冊和識別號 (EORI)作為識別號。
EORI 編號是在整個歐盟範圍內有效的運營商識別號， 醫療器材產品進口、銷售時必須在產品上貼上CE合規標誌。
歐洲市場上的每一個醫療器材都必須有CE 標誌。CE 標誌意味著產品符合法律要求。
對於 I 類醫療器材（非無菌和/或非測量），評估產品是否符合醫療器材指令。
IIa、IIb 和 III 類醫療器材必須由獨立權威機構（公告機構）進行檢查。
如果該機構批准該產品，將收到 CE 證書，才能銷售醫療設備。
商品進口荷蘭需要確認以下項目
1.產品受到保護
進口產品應先確定是否受任何商標、設計、專利或版權法的約束。
2.貨物允許
對於來自歐盟以外的貨物，荷蘭海關會檢查是否遵守有關安全、健康、經濟和環境的法規。
3.如果從歐洲經濟區以外進口產品，須徵得生產商許可
如果生產商允許，能從歐洲經濟區(EEA) 以外的國家進口和銷售產品，未經許可的進口稱為平行進口。
4.進口許可證
食品補充劑需要符合歐盟法規才能進口，無進口許可證。
5.檢查貨物符合商品法
在荷蘭生產、準備或交易食品或其他消費品必須遵守商品法。該法案提供了關於公共衛生、產品安全、貿易公平和適當信息的一般規則。
6. 與供應商達成明確協議
簽訂銷售合約、分銷協議或代理協議，在其中明確說明責任、保證等問題達成的協議，並指明哪個國家/地區的法律將管轄商業關係。
7. 考慮產品責任
如果從歐盟以外進口產品在荷蘭市場上使用並造成損害，需要作為進口商承擔責任，進口商可以安排產品責任保險。
8.對包裝材料的責任
如果在荷蘭製造或進口包裝或包裝產品，有責任管理包裝直到廢物階段（生產者責任）。
9.向海關申報貨物
如果從歐盟以外的國家/地區進口商品，必須向海關申報。也可以讓運輸公司、物流服務提供商或海關代理執行。根據申報，海關將計算進出口關稅。
10.繳納進口稅
將貨物進口到荷蘭時，需要繳納各種稅款（進口稅、增值稅、消費稅等）。進口稅的支付金額取決於產品的種類和原產國。
11.醫療器材需確認擁有CE標誌
海關
1. 經濟經營者註冊和識別
於荷蘭海關註冊取得EORI 編號
(網頁：
https://www.belastingdienst.nl/wps/wcm/connect/en/customs/content/how-to-obtain-an-eori-number)
申請書內容：
．公司名稱、地址、郵政編碼、城鎮/城市
．RSIN/BSN
．增值稅識別號
．簽名
2. 通過AGS 系統（荷蘭語）進行貨物進出口的電子申報。
申報單內容：
．姓名/公司名稱、地址、郵政編碼、城鎮
．商會編號
．EORI 編號或 RSIN
．聯繫人姓名
．海關業務、角色、電話號碼
．聲明
．14 天內的預期船舶數量
．船舶的長度以及相應的關稅
．14 天內到期的總關稅等
無銷售許可證。
Products bearing the CE certification label can be sold freely in all European Economic Community (EEC) member states without the need to undergo product testing in other countries. Goods manufactured outside the EU must have a full customs declaration in order to be freely sold within the EU market. Businesses and individuals wishing to trade are required to use the Economic Operator Registration and Identification Number (EORI) as their identification number in all customs procedures. The EORI number is an operator identification number valid throughout the EU, and the CE compliance mark must be affixed to the product when medical device is imported or sold.
Every medical device on the European market must be CE marked. CE marking means that the product meets legal requirements. For Class I medical devices (non-sterile and/or non-measured), evaluate the product for compliance with the Medical Device Directive. Class IIa, IIb and III medical devices must be inspected by an independent authority (Notified Body). If the agency approves the product, it will receive a CE certificate before it can be sold as a medical device.
Commodities imported into the Netherlands need to confirm the following items:
1. Products are protected
Importing products should first determine if they are subject to any trademark, design, patent or copyright laws.
2. Goods allowed
For shipments from outside the EU, Dutch customs checks compliance with regulations regarding safety, health, economy and environment.
3. If the product is imported from outside the European Economic Area, a manufacturer’s license is required
If the manufacturer allows it to import and sell products from countries outside the European Economic Area (EEA), unauthorised importation is called parallel importation.
4. Import Licence
Food supplements need to comply with EU regulations to be imported without an import license.
5. Check that the goods comply with the Commodities Act
The production, preparation or trading of food or other consumer products in the Netherlands is subject to commodity law. The Act provides general rules regarding public health, product safety, trade fairness, and appropriate information.
6. Make a clear agreement with the supplier
Enter into a sales contract, distribution agreement, or agency agreement that clearly states the agreement reached on issues of liability, warranties, etc., and indicates which country’s law will govern the commercial relationship.
7. Consider product liability
If a product imported from outside the EU is used on the Dutch market and causes damage, it is liable as an importer, who can arrange product liability insurance.
8. Liability for packaging materials
If packaging or packaging products are manufactured or imported in the Netherlands, there is a responsibility to manage the packaging until the waste stage (producer responsibility).
9. Declaration of goods to customs
If you import goods from a country outside the EU, you must declare it to customs. It can also be performed by transport companies, logistics service providers or customs agents. Customs will calculate import and export duties based on the declaration.
10. Pay import duties
When importing goods into the Netherlands, various taxes (import duty, value added tax, excise duty, etc.) are required to be paid. The amount of import duty paid depends on the type and country of origin of the product.
11. Medical device needs to confirm that it has CE mark.
Customs
1. Economic Operator Registration and Identification
Registered with Dutch customs to obtain EORI number
(Web page:
https://www.belastingdienst.nl/wps/wcm/connect/en/customs/content/how-to-obtain-an-eori-number)
Application form content:
．Company Name, Address, Postal Code, Town/City
．RSIN/BSN
．VAT ID
．Sign
2. Electronic declaration of import and export of goods via the AGS system (in Dutch).
Declaration form content:
．Name/Company Name, Address, Postal Code, Town
．Chamber number
．EORI number or RSIN
．Contact name
．Customs operations, roles, phone numbers
．Statement
．Expected number of ships in 14 days
．The length of the vessel and the corresponding tariff
．Total duties due in 14 days etc.
No sales license.
【參考連結】
https://business.gov.nl/regulation/medical-devices/
HLF-NL-70
荷蘭醫療器材審核機構，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 標誌
在歐盟 (EU) 銷售醫療器材，產品皆須要取得 CE 標誌：CE 標誌應明顯、清晰、不可磨滅地貼在器材或其無菌包裝上。
如果由於設備的性質而無法或不能保證這種粘貼，則應在包裝上粘貼 CE 標誌。CE 標誌也應出現在任何使用說明和任何銷售包裝上。
1. CE 標誌應由以下形式的首字母“CE”組成：
2. 如果CE標誌縮小或放大，應遵守上述刻度圖中給出的比例。
3. CE標誌的各個組成部分應具有基本相同的垂直尺寸，不得小於5mm。對於小型設備，可以免除此最小尺寸。
醫療器材依據其分類申請CE認證具備內容：
1. ClassI：自我宣告即可
2. ClassIIa/ClassIIb/ClassIII:須符合相對應之醫療器材指令，通過認證機構評鑑(Notified Body Conformity Assessment Procedure)，取得CE證書。
注意事項：
1. I 類（非無菌、非測量）需要符合上市後監控(PMS) 機制。
．製造商應依器材風險等級和醫材分類，規劃、建立、文件化、施行、維護與持續更新上市後監督系統，以確認產品生命週期間的安全與功效。
2. 除 I 類（非無菌、非測量）以外的所有設備，需要實施質量管理體系(QMS) 。
．產品在取得認證文件後才可印上CE標誌。製造商、代理或進口商經過內部設立的產品檢測部門檢測，或會邀請外部的驗證機構測試產品實施品質管理，確保量產產品符合檢驗合格之樣品。
3. I 類到 IIb 類，需要一份技術文件，II 類/AIMD 設備為設計檔案。
．製造商或任何授權代表的姓名和地址
．產品的簡要說明
．產品的標識，例如產品的序列號
．產品設計和製造所涉及的設施的名稱和地址
．參與評估產品符合性的任何公告機構的名稱和地址
．已遵循的合格評定程序的聲明
．歐盟符合性聲明
．標籤和使用說明
．產品符合的相關法規的聲明
．識別聲稱符合的技術標準
．零件清單
．試驗結果
4. IIa 類、IIb 類和 III 類器材的製造商應為每個器材準備一份定期安全更新報告（PSUR），並在與每個類別或器材組相關的情況下，總結後期分析的結果和結論。
5. 歐洲辦事處或授權代表的名稱和地址放在使用說明、外包裝或設備標籤上。
6. 除 I 類（非無菌、非測量）以外的所有設備，其 QMS 和技術文件或設計檔案皆必須由認證機構（歐洲當局認可的第三方審核醫療器材公司和產品）進行審核。
臨床調查和性能研究
製造商將醫療器材或體外診斷醫療器材 (IVD) 投放市場之前必須首先進行臨床評估。
對於醫療器材，這是一項臨床研究，對於體外診斷醫療器材，這是一項性能研究。
需要進行臨床調查，通知健康和青年監察局(IGJ) 對產品的安全性進行實驗室測試。
1. 製造商必須向 人體受試者的研究中央委員會（CCMO） 註冊任何涉及醫療器材的臨床調查。
2. 通過在 ToetsingOnline 中填寫表格註冊調查。
3. 基本文件
．信函：申請信、製造商授權、如果製造商不在歐盟內，則由歐盟法定代表人授權。
．表格：評估和登記表、Eudamed 表格、通知終止調查表隔。
．議定書：研究方案、議定書修正案。
．產品信息：研究者手冊 (IB) 、研究性醫療器材檔案 (IMDD) 、由製造商（或其授權代表）隊醫療器材安全性和性能聲明。
．研究信息：同意書。
．問卷：問卷調查、病人日記、病人卡、其他。
．保險：WMO研究保險證書、覆蓋範圍證明。
．簡歷：專家、調查員的簡歷。
．參與中心：名單、場地適宜性聲明 (VGO) 或研究聲明、首席研究員、每個參與中心的其他信息。
．經濟補償：研究對象的經濟補償、調查人員和參與中心的經濟補償。
．其他文件：其他當局的建議、其他歐盟成員國評估、臨床試驗協議、科學出版物、數據安全監察委員會 (DSMB)、其他信息、臨床評估計劃、個人數據處理的描述。
CE marking
The sale of medical devices in the European Union (EU) requires CE marking of products: the CE marking should be conspicuously, clearly and indelibly affixed to the device or its sterile packaging. If, due to the nature of the device, such affixing is not possible or warranted, the CE marking shall be affixed to the packaging. The CE marking should also appear on any instructions for use and on any sales packaging.
1. The CE marking shall consist of the initials “CE” in the following form:
2. If the CE marking is reduced or enlarged, the proportions given in the scale diagram above shall be observed.
3. The various components of the CE mark shall have substantially the same vertical dimension and shall not be less than 5mm. For small devices, this minimum size can be waived.
Medical devices applying for CE certification according to their classification have the following contents:
1. Class I: self-declaration is enough
2. ClassIIa/ClassIIb/ClassIII: Must comply with the corresponding medical device directives, pass the Notified Body Conformity Assessment Procedure, and obtain the CE certificate.
Precautions:
1. Category I (non-sterile, non-measured) requires compliance with post-market surveillance (PMS) mechanisms.
．Manufacturers should plan, establish, document, implement, maintain and continuously update post-market surveillance systems based on device risk levels and medical material classifications to confirm product safety and efficacy during the product life cycle.
2. All device other than Class I (non-sterile, non-measuring) requires the implementation of a quality management system (QMS).
．Products can only be printed with the CE mark after obtaining the certification documents. Manufacturers, agents or importers have been tested by the internal product testing department, or they may invite external verification agencies to test the products to implement quality management to ensure that the mass-produced products meet the samples that have passed the inspection.
3. For Class I to Class IIb, a technical file is required, and Class II/AIMD device is a design file.
．The name and address of the manufacturer or any authorized representative
． Brief description of the product
．Identification of the product, such as the product’s serial number
．The name and address of the facility involved in the design and manufacture of the product
．Name and address of any notified body involved in assessing product conformity
． Statement of conformity assessment procedures followed
．EU Declaration of Conformity
．Labels and Instructions for Use
．Statement of relevant regulations to which the product complies
．Identify technical standards claimed to be compliant
．Parts List
．test results
4. Manufacturers of Class IIa, IIb and III devices shall prepare a Periodic Safety Update Report (“PSUR”) for each device and, where relevant to each class or device group, summarizing the results and conclusions.
5. The name and address of the European office or authorized representative are placed on the instructions for use, on the outer packaging or on the device label.
6. For all devices other than Class I (non-sterile, non-measurement), their QMS and technical or design files must be reviewed by a certification body (a third-party audit of medical device companies and products recognized by European authorities).
Clinical investigations and performance studies
Before a manufacturer can place a medical device or in vitro diagnostic medical device (IVD) on the market, it must first conduct a clinical evaluation. For medical devices, this is a clinical study, and for in vitro diagnostic medical devices, this is a performance study. A clinical investigation is required to inform the Health and Youth Inspectorate (IGJ) to conduct laboratory testing of the product’s safety.
1. The manufacturer must register any clinical investigation involving a medical device with the Central Committee for Research in Human Subjects (CCMO).
2. Register for the survey by filling out the form in ToetsingOnline.
3. Basic documents
． Letter: Application letter, authorisation of the manufacturer, authorisation by the EU legal representative if the manufacturer is not located in the EU.
．Forms: Assessment and Registration Form, Eudamed Form, Notice of Termination Questionnaire Interval.
．Protocol: Study Protocol, Protocol Amendments.
．Product Information: Investigator Brochure (IB), Investigational Medical Device Dossier (IMDD), Medical Device Safety and Performance Statements made by the manufacturer (or its authorized representative).
．Study Information: Consent Form.
．Questionnaire: Questionnaire, patient diary, patient card, others.
． Insurance: WMO Research Insurance Certificate, Proof of Coverage.
． Resumes: Resumes of experts and investigators.
． Participating Centers: List, Site Suitability Statement (VGO) or Research Statement, Principal Investigator, other information for each participating center.
． Financial compensation: financial compensation for research subjects, financial compensation for investigators and participating centers.
．Other documents: Recommendations of other authorities, evaluations of other EU member states, clinical trial protocols, scientific publications, Data Safety Monitoring Board (DSMB), other information, clinical evaluation plan, description of personal data processing.
【參考連結】
https://europa.eu/youreurope/business/product-requirements/labels-markings/ce-marking/index_en.htm
https://english.igj.nl/medical-technology/market-authorisation/clinical-research
HLF-NL-75
荷蘭醫療器材審核機構，能夠接受海外檢驗機構的檢驗資料嗎？假如是的話，有些被認可的機構？網頁？
Evershine RD：
醫療器材的CE認證只有在歐盟網站公告的指定驗證機構(歐盟境內)，才具備醫療器材的CE符合性證書發證資格。
HLF-NL-77
HLF-NL-80
外國子公司進口醫療器材後，如果委託荷蘭的經銷商銷售，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 Kingdom of the Netherlands 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：
經銷商無須申請醫療器材營業許可證。
產品責任
1. 醫療器材的製造商或授權代表有法律義務在荷蘭向健康和青年護理檢查局(IGJ)報告涉及任何設備的嚴重事件，且必須將與醫療器材安全相關的糾正措施通知健康和青年護理檢查局(IGJ)，包含報告嚴重事件和糾正措施 (FSCA)。
2. 報告方式：填寫電子表格並保存，然後表單作為附件添加到電子郵件中，發送電子郵件至：meldpunt@igj.nl。
3. 報告項目：
．一般召回
．設計變更
．更改使用說明
．更改產品包裝
4. 表格：
．糾正措施表現場安全糾正措施 (FSCA)
．安全通知表現場安全通知 (FSN)
．現場安全通知的澄清問題和答案
No business license is required.
Product Liability
1. The manufacturer or authorised representative of a medical device is legally obliged to report serious incidents involving any device to the Health and Youth Care Inspection Agency (IGJ) in the Netherlands and must notify the Health and Youth Care Inspection of corrective actions related to the safety of the medical device Bureau (IGJ), which includes reporting of serious incidents and corrective actions (FSCA).
2. Report: Fill out the spreadsheet and save it, then add the form as an attachment to an email, send an email to: meldpunt@igj.nl.
3. Report items:
．General recall
．Design changes
．Change instructions for use
．Change product packaging
4. Forms:
．Corrective Action Table Site Safety Corrective Action (FSCA)
．Security Notification Table Field Security Notification (FSN)
．Clarification Questions and Answers for Field Safety Notifications
【參考連結】
https://business.gov.nl/regulation/medical-devices/
HLF-NL-85
联系我们：
Email：ams4ww@evershinecpa.com
或
荷蘭永輝BPO有限公司
Amsterdam time zone:
Anna Wang, 說荷蘭文中文和英文
或
China Time Zone:
聯絡人: 陳中成 總經理 in 台+中+英;專利師;企管碩士+企管博士
Mobile: +886-933920199
in Taiwan; Mobile: +86-139-1048-6278
in China
TEL: +886-2-27170515 E100
;
Wechat id:evershiinecpa;
Line Id: evershinecpa
Skype: daleccchen
;
linkedin address:Dale Chen Linkedin
附加資訊:
台北永輝協同網路服務股份有限公司
永輝啟佳聯合會計師事務所
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
全球永輝服務據點參考資料:
永輝100%子公司：
永輝總部、臺北永輝、廈門永輝、北京永輝、上海那靈、深圳常新、紐約永輝、加州永輝、德州永輝、鳳凰城永輝、東京永輝、首爾永輝、河內永輝、越南胡志明、曼谷永輝、新加坡永輝、吉隆玻永輝、雅加達永輝、馬尼拉永輝、墨爾本永輝、澳洲雪梨、孟加拉永輝、新德里永輝、印度孟買、杜拜永輝、法蘭克福永輝、巴黎永輝、倫敦永輝、荷蘭永輝、西班牙永輝、義大利永輝、羅馬尼亞永輝、多倫多永輝、墨西哥永輝。
其他已提供中文化服務城市：
邁阿密、亞特蘭大、俄克拉荷馬、密歇根、西雅圖、特拉華；
柏林; 斯圖加特;巴黎;阿姆斯特丹;布拉格；布加勒斯特；
班加羅爾；泗水；
高雄、香港、深圳、東關、廣州、清遠、永康、杭州、蘇州、崑山、南京、重慶、許昌、青島、天津。
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.
(version:202105)
更多城市更多服務 請點擊 網站導覽
