越南醫療器材登記法規問題集

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各國醫療器材登記法規問答集

HLF-VN-10
請問越南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 Vietnam? 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：

在越南，醫療器材由衛生部轄下的醫療設備和衛生工程部（DMEHW）監管。醫療器材是一種設備、工具、材料和化學品、必要的軟體，可以：

1. 單獨使用或相互結合使用，以達到以下目的：

．診斷、預防、監測、治療和緩解疾病或補償傷害。

．檢查、更換、修改治療期間的手術支持。

．支持或維持生命。

．受孕控制。

．醫療設備的滅菌（不包括用於家庭和醫療領域的化學品、殺蟲和殺菌劑）。

．通過對人體標本的檢查，為診斷、監測或治療提供信息。

2. 器材未通過藥理學、免疫學或代謝手段在人體中或人體上實現其主要預期作用，但可以通過這些手段輔助其功能，以達成第1點所述目的。

醫療器材按照與設計和製造相關的潛在風險等級分為以下四類：

1. A 級：低風險。

2. B 類：中低風險。

3. C級：中高風險。

4. D 級：高風險。

A、B 類醫療器材的市場授權 (MA) 許可證，由註冊持有人所在省的衛生部門進行快速行政審查，註冊號將立即頒發。C 類和 D 類設備的市場授權 (MA) 許可證由醫療設備和衛生工程部（DMEHW）批准，A、B、C、D類註冊號終生有效。

In Vietnam, medical device is regulated by the Department of Medical device and Sanitary Engineering (DMEHW) under the Ministry of Health. A medical device is a piece of device, tools, materials, chemicals, and necessary software that:

1. Used alone or in combination with each other for the following purposes:

．Diagnose, prevent, monitor, treat and mitigate disease or compensate for injury.

．Surgical support during inspections, replacements, modifications during treatment.

．Support or sustain life.

．Fertility Control.

．Sterilization of medical device (excluding chemicals, insecticides and fungicides used in the household and medical fields).

．Provides information for diagnosis, monitoring, or treatment by examining human specimens.

2. The device does not achieve its primary intended function in or on the human body by pharmacological, immunological or metabolic means, but can assist its function by these means to achieve the purpose described in point 1.

Medical devices are divided into the following four categories based on the level of potential risk associated with their design and manufacture:

1. Class A: Low risk.

2. Class B: Moderate to low risk.

3. Class C: Moderate to high risk.

4. Class D: High risk.

Market Authorization (MA) licenses for Class A and B medical devices are subject to an expedited administrative review by the health department of the province where the registration holder is located, and a registration number will be issued immediately. The Market Authorization (MA) license for Class C and Class D devices is approved by the Department of Medical device and Sanitary Engineering (DMEHW), and the Class A, B, C, D registration numbers are valid for life.

【參考連結】

https://moh.gov.vn/

HLF-VN-20
外國公司要到越南銷售醫療器材，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 Vietnam, 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：

無須申請營業許可證。

另外，醫療器材的市場授權 (MA) 許可證只有在越南當地註冊的有效公司才能註冊醫療器材，並且必須聲明醫療器材符合標準。

1. 於醫療器材管理在線公共服務系統網站(DMEC)完成企業註冊

 網頁https://dmec.moh.gov.vn/

2. 企業資料

．公司/企業名稱

．代表號或稅號

．地址、區域

．電話、傳真號碼、網頁(如果有)、電子郵件

3. 企業法定代表人資料

．姓名

．身分證字號

．電話

4. 保修地址、電話

5. 簽署承諾書

6. 醫療器材詳細資料

．醫療器材名稱

．商品名稱、全球醫療器材命名法

．產品代碼、分類、組別

．產品內容、使用目的

．製造商名稱、地址、國家

．產品質量標準

．有含藥物的醫療器材：濃度、含量、最小包裝、企業名稱、地址、國家、詳細資料(附加文件)

．ISO 13485認證

．醫療器材擁有者的授權書

．資格保證證明書

．技術文件(包含：原材料、產品安全、生產規則、臨床和臨床前研究報告、穩定度報告、技術簡介、越南文使用說明、標籤、目錄等)

．自由銷售證書

．樣本

．授權書

7.  C類和D類侵入人體的醫療器材需要匯總臨床試驗數據。

8. 作為測量儀器的醫療器材需要額外的文件，例如由科技部負責的樣品批准、檢驗和校準。

9. 繳費、提交資料

10. A、B類由所在省的衛生部門進行快速行政審查，經批准後具有終身有效性。C、D類由醫療設備和衛生工程部（DMEHW）批准，A、B、C、D類註冊號終生有效。。

C、D 類醫療器材符合下列一種情況，可採快速註冊通道

1. 已獲得獲下列任意一個機構核發之自由銷售證明(CFS)或市場授權書（Market Authorization）：

．美國Food and Drug Administration (FDA)

．澳洲Therapeutic Goods Administration (TGA)

．加拿大衛生部

．日本厚生勞動省或Pharmaceuticals and Medical Devices Agency

．歐盟成員國、英國及瑞士

．中國National Medical Products Administration

．韓國Ministry of Food & Drug Safety

．其他越南政府認可的機構

2. 已獲得由越南政府核發之進口許可證、註冊號、或CFS。

No business license is required.

Market Authorization (MA) License for Medical Devices Only valid companies registered locally in Vietnam can register medical devices, and must declare that the medical device meets the standards.

1. Complete the enterprise registration on the website of the Medical Device Management Online Public Service System (DMEC)

URL:https://dmec.moh.gov.vn/

2. Corporate Information

．Company/Business Name

．Representative number or tax number

．Address, area

．Telephone, fax number, web page (if available), email

3. Information of the legal representative of the company

．Name

．ID number

．Telephone

4. Warranty address and telephone number

5. Sign the letter of commitment

6. Details of the medical device

．Medical device name

．Trade Names, Global Medical Device Nomenclature

．Product code, classification, group

．Product content, purpose of use

．Manufacturer’s name, address, country

．Product quality standards

．Medical device containing drugs: concentration, content, minimum package, company name, address, country, detailed information (additional documents)

．ISO 13485 Certified

．Power of Attorney from the owner of the medical device

．Certificate of Eligibility Guarantee

．Technical documents (including: raw materials, product safety, production rules, clinical and pre-clinical research reports, stability reports, technical briefings, instructions for use in Vietnamese, labels, catalogs, etc.)

．Certificate of Free Sale

．Samples

．Authorization letter

7. Class C and Class D medical devices that invade the human body need to summarize clinical trial data.

8. Medical devices as measuring instruments require additional documentation, such as sample approval, inspection and calibration, which are under the responsibility of the Ministry of Science & Technology.

9. Payment, submission of materials

10. Category A and Category B are subject to rapid administrative review by the health department of the province where they are located, and are valid for life after approval. Class C and D are approved by the Department of Medical device and Hygiene Engineering (DMEHW), and the registration numbers of Class A, B, C, and D are valid for life. .

Class C and D medical devices meet one of the following conditions, and can adopt fast registration channels

1. Have obtained the Certificate of Free Sales (CFS) or Market Authorization issued by any of the following institutions:

．U.S. Food and Drug Administration (FDA)

．Therapeutic Goods Administration (TGA) of Australia

．Health Canada

．Ministry of Health, Labour and Welfare or Pharmaceuticals and Medical Devices Agency

．EU member states, UK and Switzerland

．China National Medical Products Administration

．Korea Ministry of Food & Drug Safety

．Other Vietnamese government-recognized institutions

2. An import license, registration number, or CFS issued by the Vietnamese government has been obtained.

【參考連結】

https://dmec.moh.gov.vn/tai-lieu-huong-dan-su-dung

HLF-VN-25
假如需要辦理，請問越南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：

無須申請營業許可證。

HLF-VN-30
外國公司要到越南銷售醫療器材，可以指派越南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 Vietnam, can it assign Vietnam 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，須為越南當地公司取得市場授權 (MA) 許可證方可銷售醫療器材。

醫療器材的市場授權 (MA) 許可證只有在越南當地註冊的有效公司才能註冊醫療器材，並且必須聲明醫療器材符合標準。

1. 於醫療器材管理在線公共服務系統網站(DMEC)完成企業註冊

 網頁https://dmec.moh.gov.vn/

2. 企業資料

．公司/企業名稱

．代表號或稅號

．地址、區域

．電話、傳真號碼、網頁(如果有)、電子郵件

3. 企業法定代表人資料

．姓名

．身分證字號

．電話

4. 保修地址、電話

5. 簽署承諾書

6. 醫療器材詳細資料

．醫療器材名稱

．商品名稱、全球醫療器材命名法

．產品代碼、分類、組別

．產品內容、使用目的

．製造商名稱、地址、國家

．產品質量標準

．有含藥物的醫療器材：濃度、含量、最小包裝、企業名稱、地址、國家、詳細資料(附加文件)

．ISO 13485認證

．醫療器材擁有者的授權書

．資格保證證明書

．技術文件(包含：原材料、產品安全、生產規則、臨床和臨床前研究報告、穩定度報告、技術簡介、越南文使用說明、標籤、目錄等)

．自由銷售證書

．樣本

．授權書

7.  C類和D類侵入人體的醫療器材需要匯總臨床試驗數據。

8. 作為測量儀器的醫療器材需要額外的文件，例如由科技部負責的樣品批准、檢驗和校準。

9. 繳費、提交資料

10. A、B類由所在省的衛生部門進行快速行政審查，經批准後具有終身有效性。C、D類由醫療設備和衛生工程部（DMEHW）批准，A、B、C、D類註冊號終生有效。。

C、D 類醫療器材符合下列一種情況，可採快速註冊通道

1. 已獲得獲下列任意一個機構核發之自由銷售證明(CFS)或市場授權書（Market Authorization）：

．美國Food and Drug Administration (FDA)

．澳洲Therapeutic Goods Administration (TGA)

．加拿大衛生部

．日本厚生勞動省或Pharmaceuticals and Medical Devices Agency

．歐盟成員國、英國及瑞士

．中國National Medical Products Administration

．韓國Ministry of Food & Drug Safety

．其他越南政府認可的機構

2. 已獲得由越南政府核發之進口許可證、註冊號、或CFS。

市場授權 (MA) 許可證持有人應當負責組織管理醫療器材投放市場紀錄及不良事件處理，並完整保留下列文件：

1.醫療器材註冊號核發申請書

．產品所有者向申請註冊的組織發出的授權書

．產品所有人授予的保修資格證明，但產品所有人規定的一次性醫療器材或有文件證明該醫療器材不在保修期內的除外

．CFS 或上市許可

2.流通記錄（註冊號持有人為代表機構的，不要求保留該記錄，但必須要求其授權的醫療器材進口單位履行該職責）。

3.不良事件、投訴和糾正措施的記錄，表明醫療器材的名稱、類別、數量和批號，特別是那些有缺陷或對用戶不安全的。

4.醫療器材質量管理文件

．依照貨物原產地法律規定製作的原產地證書

．醫療器材註冊申請中載明名稱的產品所有人或製造商出具的每批醫療器材的質量證明書

．醫療器材檢查記錄

．醫療器材維修、保養服務的技術文件，但產品所有者規定的一次性醫療器材或有文件證明該醫療器材不在保修期內的除外

．醫療器材的使用說明以越南語提供

．保修中心、條件、時間等信息，產品所有者規定的一次性醫療器材或有文件證明該醫療器材不在保修期內的除外

Yes. A market authorization (MA) license must be obtained for a local company in Vietnam to sell medical device.

Market Authorization (MA) License for Medical Devices Only valid companies registered locally in Vietnam can register medical devices, and must declare that the medical device meets the standards.

1. Complete the enterprise registration on the website of the Medical Device Management Online Public Service System (DMEC)

URL:https://dmec.moh.gov.vn/

2. Corporate Information

．Company/Business Name

．Representative number or tax number

．Address, area

．Telephone, fax number, web page (if available), email

3. Information of the legal representative of the company

．Name

．ID number

．Telephone

4. Warranty address and telephone number

5. Sign the letter of commitment

6. Details of the medical device

．Medical device name

．Trade Names, Global Medical Device Nomenclature

．Product code, classification, group

．Product content, purpose of use

．Manufacturer’s name, address, country

．Product quality standards

．Medical device containing drugs: concentration, content, minimum package, company name, address, country, detailed information (additional documents)

．ISO 13485 Certified

．Power of Attorney from the owner of the medical device

．Certificate of Eligibility Guarantee

．Technical documents (including: raw materials, product safety, production rules, clinical and pre-clinical research reports, stability reports, technical briefings, instructions for use in Vietnamese, labels, catalogs, etc.)

．Certificate of Free Sale

．Samples

．Authorization letter

7. Class C and Class D medical devices that invade the human body need to summarize clinical trial data.

8. Medical devices as measuring instruments require additional documentation, such as sample approval, inspection and calibration, which are under the responsibility of the Ministry of Science & Technology.

9. Payment, submission of materials

10. Category A and Category B are subject to rapid administrative review by the health department of the province where they are located, and are valid for life after approval. Class C and D are approved by the Department of Medical device and Hygiene Engineering (DMEHW), and the registration numbers of Class A, B, C, and D are valid for life. .

Class C and D medical devices meet one of the following conditions, and can adopt fast registration channels

1. Have obtained the Certificate of Free Sales (CFS) or Market Authorization issued by any of the following institutions:

．U.S. Food and Drug Administration (FDA)

．Therapeutic Goods Administration (TGA) of Australia

．Health Canada

．Ministry of Health, Labour and Welfare or Pharmaceuticals and Medical Devices Agency

．EU member states, UK and Switzerland

．China National Medical Products Administration

．Korea Ministry of Food & Drug Safety

．Other Vietnamese government-recognized institutions

2. An import license, registration number, or CFS issued by the Vietnamese government has been obtained.

The market authorization (MA) license holder shall be responsible for the organization and management of the medical device release record and adverse event handling, and keep the following documents intact:

1. Application for issuance of medical device registration number

．Power of Attorney issued by the product owner to the organization applying for registration

．Warranty eligibility certificate granted by the product owner, except for disposable medical devices specified by the product owner or documents proving that the medical device is out of warranty

．CFS or Marketing Authorization

2. Circulation records (if the holder of the registration number is a representative institution, it is not required to keep this record, but the authorized medical device importer must be required to perform this duty).

3. Records of adverse events, complaints, and corrective actions, indicating the name, category, quantity, and lot number of medical devices, especially those that are defective or unsafe to users.

4. Medical device quality management documents

．Certificate of origin made in accordance with the laws of the origin of the goods

．Quality certificate for each batch of medical devices issued by the owner or manufacturer of the product named in the medical device registration application

．Medical device inspection records

．Technical documents for medical device repair and maintenance services, except for disposable medical device specified by the product owner or documents proving that the medical device is not within the warranty period

．Instructions for use of medical device are provided in Vietnamese

．Warranty center, conditions, time and other information, except for disposable medical device specified by the product owner or documents proving that the medical device is not within the warranty period

【參考連結】

https://dmec.moh.gov.vn/web/guest/thong-bao

HLF-VN-35

假如需要辦理指派越南公司擔任營業代理人，請問越南有專業服務公司可以協助？

HLF-VN-40
外國公司銷售到越南醫療器材本身，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 Vietnam? 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，需以越南當地公司名義取得市場授權 (MA) 許可證。

醫療器材的市場授權 (MA) 許可證只有在越南當地註冊的有效公司才能註冊醫療器材，並且必須聲明醫療器材符合標準。

1. 於醫療器材管理在線公共服務系統網站(DMEC)完成企業註冊

 網頁https://dmec.moh.gov.vn/

2. 企業資料

．公司/企業名稱

．代表號或稅號

．地址、區域

．電話、傳真號碼、網頁(如果有)、電子郵件

3. 企業法定代表人資料

．姓名

．身分證字號

．電話

4. 保修地址、電話

5. 簽署承諾書

6. 醫療器材詳細資料

．醫療器材名稱

．商品名稱、全球醫療器材命名法

．產品代碼、分類、組別

．產品內容、使用目的

．製造商名稱、地址、國家

．產品質量標準

．有含藥物的醫療器材：濃度、含量、最小包裝、企業名稱、地址、國家、詳細資料(附加文件)

．ISO 13485品質管理認證書

．醫療器材擁有者的授權書

．資格保證證明書

．技術文件(包含：原材料、產品安全、生產規則、臨床和臨床前研究報告、穩定度報告、技術簡介、越南文使用說明、標籤、目錄等)

．自由銷售證書

．樣本

7.  C類和D類侵入人體的醫療器材需要匯總臨床試驗數據。

8. 作為測量儀器的醫療器材需要額外的文件，例如由科技部負責的樣品批准、檢驗和校準。

9. 繳費、提交資料

10. A、B類由所在省的衛生部門進行快速行政審查，經批准後具有終身有效性。C、D類由醫療設備和衛生工程部（DMEHW）批准，A、B、C、D類註冊號終生有效。。

C、D 類醫療器材符合下列一種情況，可採快速註冊通道

1. 已獲得獲下列任意一個機構核發之自由銷售證明(CFS)或市場授權書（Market Authorization）：

．美國Food and Drug Administration (FDA)

．澳洲Therapeutic Goods Administration (TGA)

．加拿大衛生部

．日本厚生勞動省或Pharmaceuticals and Medical Devices Agency

．歐盟成員國、英國及瑞士

．中國National Medical Products Administration

．韓國Ministry of Food & Drug Safety

．其他越南政府認可的機構

2. 已獲得由越南政府核發之進口許可證、註冊號、或CFS。

標籤

進口越南的醫療器材商品標籤的強制性內容必須用越南文書寫，標註以下內容：

1. 企業名稱和地址

2. 商品名稱

3. 原產國、製造商名稱和地址(生產貨物的國家或地區的名稱不得縮寫)

4  進口商名稱、地址

5. 型號名稱

6. 流通編號或進口許可證編號

7. 批號或序列號

8. 生產日期、有效期（滅菌或一次性醫療設備、試劑、校準物質、控製材料、化學品需要有效期）

．按日曆年的日、月、年的順序記錄，如果以不同的順序書寫，則必須用越南語對該順序進行說明。

．每個表示日、月、年的數字以兩位數記錄，年指示符允許以四位數字書寫，表示日期的日、月和年的數字必須在同一行。

9. 技術規範、警告信息

10. 使用說明

11. 存放說明

12. 保修條件

13. 某些低風險設備的使用說明 (IFU) 和軟件標籤可以線上提供。

14. 成分、定量成分

15. 其他內容

注意

1. 商品標籤上書寫的字母、數字、圖畫、圖像、標誌和符號的顏色必須清晰。對於規定的強制性內容，字母和數字的顏色必須與商品標籤的背景顏色形成對比。

2. 以下內容允許用拉丁字根的其他語言書寫：

．人類使用藥物的國際名稱或學名(如果沒有越南名稱) 。

．國際名稱或學名連同該藥物的化學式、結構式、活性成分、賦形劑和成分。

．成分的國際名稱或學名、貨物的定量成分，以防無法翻譯成越南語或翻譯成越南語但沒有意義。

．參與貨物生產的外國企業的名稱和地址。

3. 輔助標籤必須貼在商品或商品的商業包裝上，不得遮擋原標籤的強制性內容。

4. 商品標籤責任

．負責對商品進行標註（包括輔助標籤）的組織和個人，必須確保標註真實、清晰、準確，反映商品的真實性質。

．進口商投入流通時必須保留原標籤。

．商品標籤不得顯示與主權爭端有關的圖像和內容以及其他可能影響越南安全、政治、經濟、社會、外交關係習俗和傳統的敏感內容。

Yes, a Marketing Authorization (MA) license must be obtained in the name of a local company in Vietnam.

Market Authorization (MA) License for Medical Devices Only valid companies registered locally in Vietnam can register medical devices, and must declare that the medical device meets the standards.

1. Complete the enterprise registration on the website of the Medical Device Management Online Public Service System (DMEC)

URL:https://dmec.moh.gov.vn/

2. Corporate Information

．Company/Business Name

．Representative number or tax number

．Address, area

．Telephone, fax number, web page (if available), email

3. Information of the legal representative of the company

．Name

．ID number

．Telephone

4. Warranty address and telephone number

5. Sign the letter of commitment

6. Details of the medical device

．Medical device name

．Trade Names, Global Medical Device Nomenclature

．Product code, classification, group

．Product content, purpose of use

．Manufacturer’s name, address, country

．Product quality standards

．Medical device containing drugs: concentration, content, minimum package, company name, address, country, detailed information (additional documents)

．ISO 13485 Certified

．Power of Attorney from the owner of the medical device

．Certificate of Eligibility Guarantee

．Technical documents (including: raw materials, product safety, production rules, clinical and pre-clinical research reports, stability reports, technical briefings, instructions for use in Vietnamese, labels, catalogs, etc.)

．Certificate of Free Sale

．Samples

．Authorization letter

7. Class C and Class D medical devices that invade the human body need to summarize clinical trial data.

8. Medical devices as measuring instruments require additional documentation, such as sample approval, inspection and calibration, which are under the responsibility of the Ministry of Science & Technology.

9. Payment, submission of materials

10. Category A and Category B are subject to rapid administrative review by the health department of the province where they are located, and are valid for life after approval. Class C and D are approved by the Department of Medical device and Hygiene Engineering (DMEHW), and the registration numbers of Class A, B, C, and D are valid for life. .

Class C and D medical devices meet one of the following conditions, and can adopt fast registration channels

1. Have obtained the Certificate of Free Sales (CFS) or Market Authorization issued by any of the following institutions:

．U.S. Food and Drug Administration (FDA)

．Therapeutic Goods Administration (TGA) of Australia

．Health Canada

．Ministry of Health, Labour and Welfare or Pharmaceuticals and Medical Devices Agency

．EU member states, UK and Switzerland

．China National Medical Products Administration

．Korea Ministry of Food & Drug Safety

．Other Vietnamese government-recognized institutions

2. An import license, registration number, or CFS issued by the Vietnamese government has been obtained.

Label

The mandatory content of the product label of medical device imported into Vietnam must be written in Vietnamese and marked with the following content:

1. Company Name and Address

2. Product name

3. Country of origin, manufacturer’s name and address (the name of the country or region in which the goods are produced must not be abbreviated)

4  Importer’s name, address

5. Model name

6. Circulation number or import permit number

7. Lot or Serial Number

8. Date of manufacture, expiration date (sterilized or disposable medical device, reagents, calibration substances, control materials, chemicals require expiration dates)

．Record in the order of day, month, and year of the calendar year, and if written in a different order, the order must be stated in Vietnamese.

．Each digit representing day, month, and year is recorded with two digits, the year indicator is allowed to be written with four digits, and the digits representing day, month, and year must be on the same line.

9. Technical Specifications, Warnings

10. Instructions

11. Storage instruction

12. Warranty Conditions

13. Instructions for use (IFU) and software labels for some low-risk devices are available online.

14. Ingredients, quantitative ingredients

15. Others

Notice

1. The colors of letters, numbers, drawings, images, signs and symbols written on the product label must be clear. For prescribed mandatory content, the color of letters and numbers must contrast with the background color of the product label.

2. The following are permitted to be written in other languages ​​with Latin roots:

．The international or scientific name of the drug for human use (if there is no Vietnamese name).

．The international or scientific name along with the chemical formula, structural formula, active ingredients, excipients and ingredients of the drug.

．International or scientific names of ingredients, quantitative ingredients of the goods, in case it cannot be translated into Vietnamese or translated into Vietnamese but does not make sense.

．The name and address of the foreign enterprise involved in the production of the goods.

3. The auxiliary label must be affixed to the commodity or the commercial packaging of the commodity, and must not obscure the mandatory content of the original label.

4. Product Labeling Responsibility

．Organizations and individuals responsible for labeling products (including auxiliary labels) must ensure that the labels are true, clear, and accurate, reflecting the true nature of the products.

．The importer must retain the original label when it is put into circulation.

．Product labels must not display images and content related to sovereignty disputes and other sensitive content that may affect Vietnam’s security, politics, economy, society, customs and traditions of diplomatic relations.

【參考連結】

https://dmec.moh.gov.vn/tai-lieu-huong-dan-su-dung

HLF-VN-45

請問在越南有哪些專業服務機構，可以協助辦理醫療器材產品許可證？

HLF-VN-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?

需以越南當地公司名義取得市場授權 (MA) 許可證。

醫療器材的市場授權 (MA) 許可證只有在越南當地註冊的有效公司才能註冊醫療器材，並且必須聲明醫療器材符合標準。

1. 於醫療器材管理在線公共服務系統網站(DMEC)完成企業註冊

 網頁https://dmec.moh.gov.vn/

2. 企業資料

．公司/企業名稱

．代表號或稅號

．地址、區域

．電話、傳真號碼、網頁(如果有)、電子郵件

3. 企業法定代表人資料

．姓名

．身分證字號

．電話

4. 保修地址、電話

5. 簽署承諾書

6. 醫療器材詳細資料

．醫療器材名稱

．商品名稱、全球醫療器材命名法

．產品代碼、分類、組別

．產品內容、使用目的

．製造商名稱、地址、國家

．產品質量標準

．有含藥物的醫療器材：濃度、含量、最小包裝、企業名稱、地址、國家、詳細資料(附加文件)

．ISO 13485品質管理認證書

．醫療器材擁有者的授權書

．資格保證證明書

．技術文件(包含：原材料、產品安全、生產規則、臨床和臨床前研究報告、穩定度報告、技術簡介、越南文使用說明、標籤、目錄等)

．自由銷售證書

．樣本

7.  C類和D類侵入人體的醫療器材需要匯總臨床試驗數據。

8. 作為測量儀器的醫療器材需要額外的文件，例如由科技部負責的樣品批准、檢驗和校準。

9. 繳費、提交資料

10. A、B類由所在省的衛生部門進行快速行政審查，經批准後具有終身有效性。C、D類由醫療設備和衛生工程部（DMEHW）批准，A、B、C、D類註冊號終生有效。。

C、D 類醫療器材符合下列一種情況，可採快速註冊通道

1. 已獲得獲下列任意一個機構核發之自由銷售證明(CFS)或市場授權書（Market Authorization）：

．美國Food and Drug Administration (FDA)

．澳洲Therapeutic Goods Administration (TGA)

．加拿大衛生部

．日本厚生勞動省或Pharmaceuticals and Medical Devices Agency

．歐盟成員國、英國及瑞士

．中國National Medical Products Administration

．韓國Ministry of Food & Drug Safety

．其他越南政府認可的機構

2. 已獲得由越南政府核發之進口許可證、註冊號、或CFS。

標籤

進口越南的醫療器材商品標籤的強制性內容必須用越南文書寫，標註以下內容：

1. 企業名稱和地址

2. 商品名稱

3. 原產國、製造商名稱和地址(生產貨物的國家或地區的名稱不得縮寫)

4  進口商名稱、地址

5. 型號名稱

6. 流通編號或進口許可證編號

7. 批號或序列號

8. 生產日期、有效期（滅菌或一次性醫療設備、試劑、校準物質、控製材料、化學品需要有效期）

．按日曆年的日、月、年的順序記錄，如果以不同的順序書寫，則必須用越南語對該順序進行說明。

．每個表示日、月、年的數字以兩位數記錄，年指示符允許以四位數字書寫，表示日期的日、月和年的數字必須在同一行。

9. 技術規範、警告信息

10. 使用說明

11. 存放說明

12. 保修條件

13. 某些低風險設備的使用說明 (IFU) 和軟件標籤可以線上提供。

14. 成分、定量成分

15. 其他內容

注意

1. 商品標籤上書寫的字母、數字、圖畫、圖像、標誌和符號的顏色必須清晰。對於規定的強制性內容，字母和數字的顏色必須與商品標籤的背景顏色形成對比。

2. 以下內容允許用拉丁字根的其他語言書寫：

．人類使用藥物的國際名稱或學名(如果沒有越南名稱) 。

．國際名稱或學名連同該藥物的化學式、結構式、活性成分、賦形劑和成分。

．成分的國際名稱或學名、貨物的定量成分，以防無法翻譯成越南語或翻譯成越南語但沒有意義。

．參與貨物生產的外國企業的名稱和地址。

3. 輔助標籤必須貼在商品或商品的商業包裝上，不得遮擋原標籤的強制性內容。

4. 商品標籤責任

．負責對商品進行標註（包括輔助標籤）的組織和個人，必須確保標註真實、清晰、準確，反映商品的真實性質。

．進口商投入流通時必須保留原標籤。

．商品標籤不得顯示與主權爭端有關的圖像和內容以及其他可能影響越南安全、政治、經濟、社會、外交關係習俗和傳統的敏感內容。

Marketing Authorization (MA) license must be obtained in the name of a local company in Vietnam.

Market Authorization (MA) License for Medical Devices Only valid companies registered locally in Vietnam can register medical devices, and must declare that the medical device meets the standards.

1. Complete the enterprise registration on the website of the Medical Device Management Online Public Service System (DMEC)

URL:https://dmec.moh.gov.vn/

2. Corporate Information

．Company/Business Name

．Representative number or tax number

．Address, area

．Telephone, fax number, web page (if available), email

3. Information of the legal representative of the company

．Name

．ID number

．Telephone

4. Warranty address and telephone number

5. Sign the letter of commitment

6. Details of the medical device

．Medical device name

．Trade Names, Global Medical Device Nomenclature

．Product code, classification, group

．Product content, purpose of use

．Manufacturer’s name, address, country

．Product quality standards

．Medical device containing drugs: concentration, content, minimum package, company name, address, country, detailed information (additional documents)

．ISO 13485 Certified

．Power of Attorney from the owner of the medical device

．Certificate of Eligibility Guarantee

．Technical documents (including: raw materials, product safety, production rules, clinical and pre-clinical research reports, stability reports, technical briefings, instructions for use in Vietnamese, labels, catalogs, etc.)

．Certificate of Free Sale

．Samples

．Authorization letter

7. Class C and Class D medical devices that invade the human body need to summarize clinical trial data.

8. Medical devices as measuring instruments require additional documentation, such as sample approval, inspection and calibration, which are under the responsibility of the Ministry of Science & Technology.

9. Payment, submission of materials

10. Category A and Category B are subject to rapid administrative review by the health department of the province where they are located, and are valid for life after approval. Class C and D are approved by the Department of Medical device and Hygiene Engineering (DMEHW), and the registration numbers of Class A, B, C, and D are valid for life. .

Class C and D medical devices meet one of the following conditions, and can adopt fast registration channels

1. Have obtained the Certificate of Free Sales (CFS) or Market Authorization issued by any of the following institutions:

．U.S. Food and Drug Administration (FDA)

．Therapeutic Goods Administration (TGA) of Australia

．Health Canada

．Ministry of Health, Labour and Welfare or Pharmaceuticals and Medical Devices Agency

．EU member states, UK and Switzerland

．China National Medical Products Administration

．Korea Ministry of Food & Drug Safety

．Other Vietnamese government-recognized institutions

2. An import license, registration number, or CFS issued by the Vietnamese government has been obtained.

Label

The mandatory content of the product label of medical device imported into Vietnam must be written in Vietnamese and marked with the following content:

1. Company Name and Address

2. Product name

3. Country of origin, manufacturer’s name and address (the name of the country or region in which the goods are produced must not be abbreviated)

4  Importer’s name, address

5. Model name

6. Circulation number or import permit number

7. Lot or Serial Number

8. Date of manufacture, expiration date (sterilized or disposable medical device, reagents, calibration substances, control materials, chemicals require expiration dates)

．Record in the order of day, month, and year of the calendar year, and if written in a different order, the order must be stated in Vietnamese.

．Each digit representing day, month, and year is recorded with two digits, the year indicator is allowed to be written with four digits, and the digits representing day, month, and year must be on the same line.

9. Technical Specifications, Warnings

10. Instructions

11. Storage instruction

12. Warranty Conditions

13. Instructions for use (IFU) and software labels for some low-risk devices are available online.

14. Ingredients, quantitative ingredients

15. Others

Notice

1. The colors of letters, numbers, drawings, images, signs and symbols written on the product label must be clear. For prescribed mandatory content, the color of letters and numbers must contrast with the background color of the product label.

2. The following are permitted to be written in other languages ​​with Latin roots:

．The international or scientific name of the drug for human use (if there is no Vietnamese name).

．The international or scientific name along with the chemical formula, structural formula, active ingredients, excipients and ingredients of the drug.

．International or scientific names of ingredients, quantitative ingredients of the goods, in case it cannot be translated into Vietnamese or translated into Vietnamese but does not make sense.

．The name and address of the foreign enterprise involved in the production of the goods.

3. The auxiliary label must be affixed to the commodity or the commercial packaging of the commodity, and must not obscure the mandatory content of the original label.

4. Product Labeling Responsibility

．Organizations and individuals responsible for labeling products (including auxiliary labels) must ensure that the labels are true, clear, and accurate, reflecting the true nature of the products.

．The importer must retain the original label when it is put into circulation.

．Product labels must not display images and content related to sovereignty disputes and other sensitive content that may affect Vietnam’s security, politics, economy, society, customs and traditions of diplomatic relations.

【參考連結】

https://vbpl.vn/TW/Pages/vbpq-van-ban-goc.aspx?ItemID=122041

https://dmec.moh.gov.vn/tai-lieu-huong-dan-su-dung

HLF-VN-55

請問在越南有哪些專業服務機構，可以協助以外國公司名義辦理醫療器材產品許可證？

>HLF-VN-60
經過核准登記的醫療器材，進口到越南要檢附什麼文件？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 Vietnam? What is the procedure? Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?

Evershine RD：

需要以越南當地公司名義申請進口許可證。

進口商必須滿足以下條件：

1. 擁有越南企業法、合作法或投資法規定的充分法律文件。

2. 具有滿足下列條件的技術人員和物質基礎

．首席技術員必須具備以下學歷之一： 醫學生物電子學大學學歷；大學技術文憑；醫學或藥學大學文憑和合法醫療器材培訓機構頒發的醫療器材專業培訓證書或國外頒發的同等證書，培訓時間不少於1個月。

．具有上述學歷，並經所在單位負責人認證直接在醫療機構工作或管理醫療設備3年以上的人員，可免取得醫療設備專業培訓證書。

．有能夠指導貿易商經營的醫療器材安裝、維修的技術幹部和人員（每年接受器材生產企業培訓）。

．有總部、適當的倉庫，滿足良好保存醫療設備的條件，有足夠的工具、技術設備和設施進行醫療設備的安裝、維護；有足夠的防火、防爆和滅火設備，必須按照法律規定確保環境安全和衛生。

3. 越南境外的公司都不能以自己的名義持有進口許可證或產品註冊。申請和持有許可證者必須是在越南註冊和經營的公司實體。

進口許可證申請

1. 醫療器材進口許可申請書。

2. 證明符合資格的相關文件。

3. 隨附的文件，包括

．各類設備的目錄（原件）

．生產商 ISO-9001、ISO 14000 或同等質量控制證書

．產品在生產國流通的許可證

4. 資料必須完整送至衛生部 醫療設備和衛生工程部 ( DMEHW )並提交衛生部科學技術委員會審議和授予進口許可證。

5. 獲得許可的進口商必須按照財政部的規定支付費用。

6. DMEHW 通常會在收到申請文件後的 15 個工作日內授予進口許可證，除非需要進行臨床試驗。

7. 可以接受外國臨床試驗結果，但必須已被外國醫療監管機構接受並在原產國註冊醫療器材。此外，衛生部科學技術委員會必須審查和批准外國臨床試驗結果，如果衛生部決定還必須在越南進行臨床試驗才能獲得批准的產品，衛生部將自行組織和進行試驗，通常需要在三個或更多醫院進行，試驗可能需要 3 到 12 個月才能完成，在某些情況下甚至更長時間。如果需要進行臨床試驗，但在越南境內外未進行過試驗，DMEHW 將安排由申請人負責準備臨床試驗方案。在試驗結束時，醫院會將結果傳回給 DMEHW 和申請人。然後申請人應重新提交申請並附上試驗結果，DMEHW 將在另外 15 個工作日內發布。

海關

1. 所有進口到越南的貨物都必須申報並徵稅，除非貨物符合免稅或稅收保護的條件。貿易商可通過國家單一窗口或越南自動清關系統 (VNACCS) 提交所需信息、電子報關單。進口稅醫療器材通常為 0%，增值稅醫療器材為 5%。

2. 進口商需自到貨之日起30日內通過VNACCS系統提交完整無誤的電子報關單、運輸單證信息（如提單等）。

3.  申報報關提交文件

．已簽署的報關單（原件）

．商業登記證複印件

．授權書原件或公證副本

．原產國的自由銷售證明

．商業發票（複印件）

．銷售合同（複印件）

．定期提單或空運提單

．貨物清單（如有）

．原產地證書（C/O）

．裝箱單

．價值聲明（如有）

．收據（如有）

．原產地證書（如有）

．衛生和安全性之文件

．醫療器材進口許可證

4. 按規定繳納稅費，接收清關信息。

5.報關單內容

．報關登記海關分部

．提交日期和時間

．註冊日期和時間

．進口口岸海關分局

．申報附件數量

．出口商、類型

．商業發票

．許可證號

．合同

．進口商

．提單（編號/日期）

．裝貨港、卸貨港

．受託人/委託人

．運輸工具

．出口國

．報關員

．到貨日期

．交貨條件

．付款方式、支付貨幣、稅率

．商品說明、產品代碼、項目、數量、價值等

5.倉儲

．如果進口商不打算立即將貨物投入越南流通，可以根據海關倉庫儲存制度進口到越南。商品入庫時實行稅收保護，商品投入流通時才徵收稅款。

．貿易商在入庫時需要提交保稅倉儲制度下的進口報關單，在貨物進入流通時需要提交正規的進口報關單。

．倉庫有多種類型（保稅倉庫、暫緩稅倉庫），帶入倉庫的貨物必須得到越南海關總署或財政部的批准。

無銷售許可證，但於產品許可證持有人在銷售醫療器材前需要在DMEC價格申報門戶網站上申報醫療器材價格。

1. 申請網頁：https://kekhaigiattbyt.moh.gov.vn/

2. 必備資料/文件

．設備名稱

．商品名稱

．分類

．產品持有公司、代碼

．製造商國家、公司

．單位

．包裝

．配置、技術特性、附加服務

．進口成本或生產成本

．預期利潤

．最高售價

．價格生效日期、價格有效日期

3.其他資料(非必須)

．獲批流通編號/進口許可證資料

．代碼全球醫療器材命名法(GMDN)

．設備圖像

．設備類型：國產設備或進口設備

．附在成本價上的文件

．資本成本

．附在利潤上的文件

．利潤說明

．附在最高售價上的文件

．最高售價

．組件和配件的價格

．保修、維護、保養費用

．培訓費用

．其他費用

4.可以逐筆輸入，抑或下載excel檔案批次上傳(一次最多100筆)。

The import license must be applied for in the name of a local company in Vietnam.

Importers must meet the following conditions

1. Possess sufficient legal documents stipulated by Vietnam’s Enterprise Law, Cooperation Law or Investment Law.

2. Have technical personnel and material bases that meet the following conditions

．The chief technician must possess one of the following qualifications: University degree in Medical Bioelectronics; University Technical Diploma; University Diploma in Medicine or Pharmacy and Medical Device Professional Training Certificate issued by a legitimate medical device training institution or an equivalent certificate issued abroad with a considerable amount of training time in 1 month.

．Those who have the above-mentioned educational background and who have been certified by the person in charge of their unit and who have directly worked in medical institutions or managed medical device for more than 3 years can be exempted from obtaining a professional training certificate for medical device.

．There are technical cadres and personnel who can guide the installation and maintenance of medical device operated by traders (received training by device manufacturers every year).

．There are headquarters and appropriate warehouses, meeting the conditions for good preservation of medical device, sufficient tools, technical device and facilities for the installation and maintenance of medical device; there are sufficient fire, explosion-proof and fire-fighting device, and environmental safety and security must be ensured in accordance with legal regulations. health.

3. Companies outside Vietnam cannot hold import licenses or product registrations in their own name. The applicant and holder of the license must be a corporate entity registered and operating in Vietnam.

Import License Application Process

1. Application for import license for medical device.

2. Relevant documents to demonstrate eligibility.

3. Accompanying documents, including

．Catalogue of various types of device (original)

．Manufacturer ISO-9001, ISO 14000 or equivalent quality control certificate

．License to circulate the product in the country of production

4. The data must be completely sent to the Ministry of Health’s Department of Medical device and Sanitary Engineering (DMEHW) and submitted to the Ministry of Health Science and Technology Committee for review and grant of import license.

5. Licensed importers must pay fees in accordance with the regulations of the Ministry of Finance.

6. The DMEHW will normally grant the import license within 15 working days of receipt of the application documents, unless clinical trials are required.

7. Foreign clinical trial results are acceptable, but the medical device must have been accepted by the foreign medical regulatory agency and registered in the country of origin. In addition, the Science and Technology Committee of the Ministry of Health must review and approve the results of foreign clinical trials. If the Ministry of Health decides that clinical trials must also be conducted in Vietnam to obtain an approved product, the Ministry of Health will organize and conduct the trials on its own, usually within three or more Conducted in hospitals, trials can take anywhere from three to 12 months to complete, and in some cases even longer. If a clinical trial is required but has not been conducted in or outside Vietnam, DMEHW will arrange for the applicant to prepare the clinical trial protocol. At the conclusion of the trial, the hospital will communicate the results back to the DMEHW and the applicant. The applicant should then resubmit the application with the trial results and the DMEHW will publish it within another 15 working days.

Customs process

1. All goods imported into Vietnam must be declared and taxed unless the goods are eligible for tax exemption or tax protection. Traders can submit the required information, electronic customs declarations through the National Single Window or the Vietnam Automated Customs Clearance System (VNACCS). Import duty on medical devices is usually 0%, and VAT on medical devices is 5%.

URL: https://dknsd.customs.gov.vn/Pages/dn.aspx

2. Importers are required to submit complete and correct electronic customs declarations and transport documents (such as bills of lading, etc.) through the VNACCS system within 30 days from the date of arrival.

3. Declaration and submission of documents

．Signed customs declaration (original)

．Copy of business registration certificate

．Original power of attorney or notarized copy

．Certificate of free sale in the country of origin

．Commercial Invoice (copy)

．Sales contract (copy)

．Periodic Bill of Lading or Air Waybill

．List of goods (if any)

．Certificate of Origin (C/O)

．Packing List

．Value statement (if any)

．Receipts (if any)

．Certificate of Origin (if any)

．Health and Safety Documentation

．Medical device Import License

4. Pay taxes and fees and receive customs clearance information as required.

5. Contents of customs declaration

．Customs Registration and Customs Division

．Submission date and time

．Registration date and time

．Import port customs branch

．Number of declaration attachments

．Exporter, Type

．Commercial invoice

．Permit number

．Contract

．Importers

．Bill of Lading (No/Date)

．Port of Loading, Port of Unloading

．Trustee / Settlor

．Means of transport

．Export country

．Customs declarer

．Arrival date

．Delivery terms

．Payment method, payment currency, tax rate

．Commodity description, product code, item, quantity, value, etc.

5. Storage

．If the importer does not plan to put the goods into Vietnam for circulation immediately, they can import to Vietnam according to the customs warehouse storage system. Tax protection is implemented when commodities are put into storage, and taxes are collected when commodities are put into circulation.

．Traders need to submit import declaration forms under the bonded warehousing system when they enter the warehouse, and they need to submit formal import declaration forms when goods enter circulation.

．There are various types of warehouses (bonded warehouses, deferred tax warehouses), and the goods brought into the warehouses must be approved by the Vietnam Customs Department or the Ministry of Finance.

No sales license, but product license holders need to declare the price of medical devices on the DMEC price declaration portal before they can sell medical devices.

1. Application website: https://kekhaigiattbyt.moh.gov.vn/

2. Required Information/Documents

．Device name

．Product name

．Classification

．Product holding company, code

．Manufacturer Country, Company

．Units

．Package

．Configuration, technical features, additional services

．Import cost or production cost

．Expected Profit

．Highest selling price

．Price Effective Date, Price Effective Date

3. Other information (not required)

．Approved Circulation Number/Import License Information

．Code Global Medical Device Nomenclature (GMDN)

．Device image

．Device type: domestic device or imported device

．Documents attached to cost price

．Capital cost

．Document attached to profit

．Profit statement

．Documents attached to the highest selling price

．Highest selling price

．Prices of components and accessories

．Warranty, Maintenance, Maintenance Fees

．Training fee

．Other fee

4. You can input one by one, or download excel files and upload them in batches (up to 100 at a time).

【參考連結】

https://moh.gov.vn/

https://dmec.moh.gov.vn/dich-vu-cong/-/dvc/thutuchanhchinh/1117.html

https://www.vietnamtradeportal.gov.vn/index.php?r=site/display&id=795#Gi%E1%BA%A5y%20ph%C3%A9p%20nh%E1%BA%ADp%20kh%E1%BA%A9u

>HLF-VN-70
越南醫療器材審核機構，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.製造商具備ISO 13485認證

．一般要求(商業執照、許可證、相關證明文件等)

． 文件要求(ISO流程紀錄、醫療器材紀錄、質量控制程序、文件控制程序、質量目標、質量方針、質量手冊、部門應用流程/表格、內部門審計紀錄等)

．管理責任(部門、負責人及職責)

．資源

．產品實現

．基礎設施

．風險管理

2.技術文件

．醫療器材產品說明

醫療設備說明(原材料、產品安全、生產規則、臨床和臨床前研究報告、穩定度報告、技術簡介)、組件和附件清單（包括隨附的化學品）、標籤上所述的用途/指示、用戶手冊（越南文）、禁忌症、警告和注意、發生特定的不良反應

．已在其他國家流通的產品信息（如有）

．在其他國家註冊的名稱（如有）

．醫療器材產品的安全/顯著操作信息

3. 進口醫療器材產品在製造國的自由銷售證明（CFS）

由進口國官方機構簽發的自由銷售證明，如果CFS使用的語言不是英語或越南語，則必須翻譯成越南語。須以英文 A4 尺寸白皮書製作，並包含以下基本信息：

．簽發 CFS 的機構名稱

．委員、參考編號

．委簽發日期

．授予 CFS 的產品和貨物名稱

．授予 CFS 的產品和貨物的類型或組別

．製造商的名稱和地址

．必須明確說明產品和貨物是在生產國市場上自由生產和銷售的。

． CFS 發行人的全名、簽名、職務和 CFS 發行人的印章

4. 授權書

製造商授權進口商之委託書，如果委託書使用的語言不是英語或越南語，則必須翻譯成越南語。

5. C類和D類侵入人體的醫療器材需要匯總臨床試驗數據、作為測量儀器的醫療器材需要額外的文件，例如由科技部負責的樣品批准、檢驗和校準。

1. Manufacturer with ISO 13485 certification

．General requirements (commercial licenses, permits, related supporting documents, etc.)

．Documentation requirements (ISO process records, medical device records, quality control procedures, document control procedures, quality objectives, quality policy, quality manuals, departmental application procedures/forms, internal departmental audit records, etc.)

．Management responsibilities (departments, responsible persons and responsibilities)

．Resources

．Product realization

．Infrastructure

．Risk Management

2. Technical documents

．Product Description of Medical Devices

Medical device descriptions (raw materials, product safety, manufacturing rules, clinical and preclinical study reports, stability reports, technical briefs), list of components and accessories (including accompanying chemicals), uses/instructions stated on the label, users Brochure (Vietnamese), Contraindications, Warnings and Cautions, Occurrence of Specific Adverse Reactions

．Product information already in circulation in other countries (if any)

．Name registered in another country (if any)

．Safety/significant handling information for medical device products

3. Certificate of Free Sale (CFS) of the imported medical device product in the manufacturing country

A certificate of free sale issued by the official agency of the importing country, if the language used by the CFS is not English or Vietnamese, it must be translated into Vietnamese. It must be produced in A4 size white paper in English and contain the following basic information:

．Name of the organization that issued the CFS

．Member, reference number

．Commission issue date

．Product and Goods Names Granted to CFS

．Type or group of products and goods granted to CFS

．Manufacturer’s name and address

．It must be clearly stated that products and goods are freely produced and sold on the market of the producing country.

．CFS issuer’s full name, signature, title and CFS issuer’s stamp

4. Authorization letter

The Power of Attorney from the manufacturer’s authorized importer, if the language of the Power of Attorney is not English or Vietnamese, it must be translated into Vietnamese.

5. Class C and D medical devices that invade the human body need to aggregate clinical trial data, and medical devices used as measuring instruments require additional documents, such as sample approval, inspection and calibration, which are in charge of the Ministry of Science and Technology.

【參考連結】

https://vanbanphapluat.co/circular-no-30-2015-tt-byt-import-of-medical-device

https://vanbanphapluat.co/thong-tu-24-2011-tt-byt-huong-dan-nhap-khau-trang-thiet-bi-y-te

HLF-VN-75

越南醫療器材審核機構，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？

HLF-VN-77

請問在越南有哪些醫療器材檢驗機構可以提供醫療器材檢驗服務？網頁？

HLF-VN-80
外國子公司進口醫療器材後，如果委託越南的經銷商銷售，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 Vietnam 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：

醫療器材的市場授權 (MA) 許可證只有在越南當地註冊的有效公司才能註冊醫療器材，並且必須聲明醫療器材符合標準。

市場授權 (MA) 許可證持有人應當負責組織管理醫療器材投放市場紀錄及不良事件處理，並完整保留下列文件：

1.醫療器材註冊號核發申請書

．產品所有者向申請註冊的組織發出的授權書

．產品所有人授予的保修資格證明，但產品所有人規定的一次性醫療器材或有文件證明該醫療器材不在保修期內的除外

．CFS 或上市許可

2.流通記錄（註冊號持有人為代表機構的，不要求保留該記錄，但必須要求其授權的醫療器材進口單位履行該職責）。

3.不良事件、投訴和糾正措施的記錄，表明醫療器材的名稱、類別、數量和批號，特別是那些有缺陷或對用戶不安全的。

4.醫療器材質量管理文件

．依照貨物原產地法律規定製作的原產地證書

．醫療器材註冊申請中載明名稱的產品所有人或製造商出具的每批醫療器材的質量證明書

．醫療器材檢查記錄

．醫療器材維修、保養服務的技術文件，但產品所有者規定的一次性醫療器材或有文件證明該醫療器材不在保修期內的除外

．醫療器材的使用說明以越南語提供

．保修中心、條件、時間等信息，產品所有者規定的一次性醫療器材或有文件證明該醫療器材不在保修期內的除外

Market Authorization (MA) License for Medical Devices Only valid companies registered locally in Vietnam can register medical devices, and must declare that the medical device meets the standards.

The market authorization (MA) license holder shall be responsible for the organization and management of the medical device release record and adverse event handling, and keep the following documents intact:

1. Application for issuance of medical device registration number

．Power of Attorney issued by the product owner to the organization applying for registration

．Warranty eligibility certificate granted by the product owner, except for disposable medical devices specified by the product owner or documents proving that the medical device is out of warranty

．CFS or Marketing Authorization

2. Circulation records (if the holder of the registration number is a representative institution, it is not required to keep this record, but the authorized medical device importer must be required to perform this duty).

3. Records of adverse events, complaints, and corrective actions, indicating the name, category, quantity, and lot number of medical devices, especially those that are defective or unsafe to users.

4. Medical device quality management documents

．Certificate of origin made in accordance with the laws of the origin of the goods

．Quality certificate for each batch of medical devices issued by the owner or manufacturer of the product named in the medical device registration application

．Medical device inspection records

．Technical documents for medical device repair and maintenance services, except for disposable medical device specified by the product owner or documents proving that the medical device is not within the warranty period

．Instructions for use of medical device are provided in Vietnamese

．Warranty center, conditions, time and other information, except for disposable medical device specified by the product owner or documents proving that the medical device is not within the warranty period

【參考連結】

https://dmec.moh.gov.vn/web/guest/thong-bao

HLF-VN-85

請問在越南有哪些專精於醫療器材銷售與消費權益相關法律服務的業者？

各國醫療器材登記法規問答集

Email：sgn4ww@evershinecpa.com
或
越南永輝BPO有限公司
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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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