越南医疗器材登记法规问题集
Email：han4ww@evershinecpa.com
或
越南永辉BPO有限公司
联络人：苏 玉 燕 副总经理
手机：+886-928-486-835
skype: rachelsu8
wechat: r0928486835
电话：+886-2-2717-0515 分机:104
HLF-VN-10
请问越南对于医疗器材的归类方式为何？它的正式名称为何？
不同归类管理强度有何差异?它的政府管辖机构为何？网页？
What are the categories of medical devices in 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，医疗器材由卫生部辖下的医疗设备和卫生工程部（DMEHW）监管。医疗器材是一种设备、工具、材料和化学品、必要的软体，可以：
1. 单独使用或相互结合使用，以达到以下目的：
．诊断、预防、监测、治疗和缓解疾病或补偿伤害。
．检查、更换、修改治疗期间的手术支持。
．支持或维持生命。
．受孕控制。
．医疗设备的灭菌（不包括用于家庭和医疗领域的化学品、杀虫和杀菌剂）。
．通过对人体标本的检查，为诊断、监测或治疗提供信息。
2. 器材未通过药理学、免疫学或代谢手段在人体中或人体上实现其主要预期作用，但可以通过这些手段辅助其功能，以达成第1点所述目的。
医疗器材按照与设计和製造相关的潜在风险等级分为以下四类：
1. A 级：低风险。
2. B 类：中低风险。
3. C级：中高风险。
4. D 级：高风险。
A、B 类医疗器材的市场授权 (MA) 许可证，由註册持有人所在省的卫生部门进行快速行政审查，註册号将立即颁发。C 类和 D 类设备的市场授权 (MA) 许可证由医疗设备和卫生工程部（DMEHW）批准，A、B、C、D类註册号终生有效。
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.
【参考连结】
HLF-VN-20
外国公司要到越南销售医疗器材，无论设100%子公司或分公司，需要在公司登记时取得营业特许证？假如要，其必要条件是什麽？所需文件及申请程序为何？网页？
If a foreign company wants to sell medical devices in 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：
无须申请营业许可证。
另外，医疗器材的市场授权 (MA) 许可证只有在越南当地註册的有效公司才能註册医疗器材，并且必须声明医疗器材符合标准。
1. 于医疗器材管理在线公共服务系统网站(DMEC)完成企业註册
2. 企业资料
．公司/企业名称
．代表号或税号
．地址、区域
．电话、传真号码、网页(如果有)、电子邮件
3. 企业法定代表人资料
．姓名
．身分证字号
．电话
4. 保修地址、电话
5. 签署承诺书
6. 医疗器材详细资料
．医疗器材名称
．商品名称、全球医疗器材命名法
．产品代码、分类、组别
．产品内容、使用目的
．製造商名称、地址、国家
．产品质量标准
．有含药物的医疗器材：浓度、含量、最小包装、企业名称、地址、国家、详细资料(附加文件)
．ISO 13485认证
．医疗器材拥有者的授权书
．资格保证证明书
．技术文件(包含：原材料、产品安全、生产规则、临床和临床前研究报告、稳定度报告、技术简介、越南文使用说明、标籤、目录等)
．自由销售证书
．样本
．授权书
7. C类和D类侵入人体的医疗器材需要汇总临床试验数据。
8. 作为测量仪器的医疗器材需要额外的文件，例如由科技部负责的样品批准、检验和校准。
9. 缴费、提交资料
10. A、B类由所在省的卫生部门进行快速行政审查，经批准后具有终身有效性。C、D类由医疗设备和卫生工程部（DMEHW）批准，A、B、C、D类註册号终生有效。。
C、D 类医疗器材符合下列一种情况，可採快速註册通道
1. 已获得获下列任意一个机构核发之自由销售证明(CFS)或市场授权书（Market Authorization）：
．美国Food and Drug Administration (FDA)
．澳洲Therapeutic Goods Administration (TGA)
．加拿大卫生部
．日本厚生劳动省或Pharmaceuticals and Medical Devices Agency
．欧盟成员国、英国及瑞士
．中国National Medical Products Administration
．韩国Ministry of Food & Drug Safety
．其他越南政府认可的机构
2. 已获得由越南政府核发之进口许可证、註册号、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)
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.
【参考连结】
https://dmec.moh.gov.vn/tai-lieu-huong-dan-su-dung
HLF-VN-25
假如需要办理，请问越南有专业服务公司可以协助办理医疗器材公司营业许可证？
Evershine RD：
无须申请营业许可证。
HLF-VN-30
外国公司要到越南销售医疗器材，可以指派越南公司担任营业代理人销售吗? 担任营业代理人，其必要条件是什麽？
所需文件及申请程序为何？外国公司与营业代理人的产品责任为何?网页？
If a foreign company wants to sell medical devices in 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，须为越南当地公司取得市场授权 (MA) 许可证方可销售医疗器材。
医疗器材的市场授权 (MA) 许可证只有在越南当地註册的有效公司才能註册医疗器材，并且必须声明医疗器材符合标准。
1. 于医疗器材管理在线公共服务系统网站(DMEC)完成企业註册
2. 企业资料
．公司/企业名称
．代表号或税号
．地址、区域
．电话、传真号码、网页(如果有)、电子邮件
3. 企业法定代表人资料
．姓名
．身分证字号
．电话
4. 保修地址、电话
5. 签署承诺书
6. 医疗器材详细资料
．医疗器材名称
．商品名称、全球医疗器材命名法
．产品代码、分类、组别
．产品内容、使用目的
．製造商名称、地址、国家
．产品质量标准
．有含药物的医疗器材：浓度、含量、最小包装、企业名称、地址、国家、详细资料(附加文件)
．ISO 13485认证
．医疗器材拥有者的授权书
．资格保证证明书
．技术文件(包含：原材料、产品安全、生产规则、临床和临床前研究报告、稳定度报告、技术简介、越南文使用说明、标籤、目录等)
．自由销售证书
．样本
．授权书
7. C类和D类侵入人体的医疗器材需要汇总临床试验数据。
8. 作为测量仪器的医疗器材需要额外的文件，例如由科技部负责的样品批准、检验和校准。
9. 缴费、提交资料
10. A、B类由所在省的卫生部门进行快速行政审查，经批准后具有终身有效性。C、D类由医疗设备和卫生工程部（DMEHW）批准，A、B、C、D类註册号终生有效。。
C、D 类医疗器材符合下列一种情况，可採快速註册通道
1. 已获得获下列任意一个机构核发之自由销售证明(CFS)或市场授权书（Market Authorization）：
．美国Food and Drug Administration (FDA)
．澳洲Therapeutic Goods Administration (TGA)
．加拿大卫生部
．日本厚生劳动省或Pharmaceuticals and Medical Devices Agency
．欧盟成员国、英国及瑞士
．中国National Medical Products Administration
．韩国Ministry of Food & Drug Safety
．其他越南政府认可的机构
2. 已获得由越南政府核发之进口许可证、註册号、或CFS。
市场授权 (MA) 许可证持有人应当负责组织管理医疗器材投放市场纪录及不良事件处理，并完整保留下列文件：
1.医疗器材註册号核发申请书
．产品所有者向申请註册的组织发出的授权书
．产品所有人授予的保修资格证明，但产品所有人规定的一次性医疗器材或有文件证明该医疗器材不在保修期内的除外
．CFS 或上市许可
2.流通记录（註册号持有人为代表机构的，不要求保留该记录，但必须要求其授权的医疗器材进口单位履行该职责）。
3.不良事件、投诉和纠正措施的记录，表明医疗器材的名称、类别、数量和批号，特别是那些有缺陷或对用户不安全的。
4.医疗器材质量管理文件
．依照货物原产地法律规定製作的原产地证书
．医疗器材註册申请中载明名称的产品所有人或製造商出具的每批医疗器材的质量证明书
．医疗器材检查记录
．医疗器材维修、保养服务的技术文件，但产品所有者规定的一次性医疗器材或有文件证明该医疗器材不在保修期内的除外
．医疗器材的使用说明以越南语提供
．保修中心、条件、时间等信息，产品所有者规定的一次性医疗器材或有文件证明该医疗器材不在保修期内的除外
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)
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
【参考连结】
https://dmec.moh.gov.vn/web/guest/thong-bao
HLF-VN-35
假如需要办理指派越南公司担任营业代理人，请问越南有专业服务公司可以协助？
HLF-VN-40
外国公司销售到越南医疗器材本身，进口前需要办理产品许可吗？如需要，哪个单位在管理？需要什麽文件？申请程序为何？
医疗器材包装内容及各种标示，需要事先核准吗？可允许的语文有哪些？网页？
Do foreign companies need to apply for an approval before importing medical devices sold to 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，需以越南当地公司名义取得市场授权 (MA) 许可证。
医疗器材的市场授权 (MA) 许可证只有在越南当地註册的有效公司才能註册医疗器材，并且必须声明医疗器材符合标准。
1. 于医疗器材管理在线公共服务系统网站(DMEC)完成企业註册
2. 企业资料
．公司/企业名称
．代表号或税号
．地址、区域
．电话、传真号码、网页(如果有)、电子邮件
3. 企业法定代表人资料
．姓名
．身分证字号
．电话
4. 保修地址、电话
5. 签署承诺书
6. 医疗器材详细资料
．医疗器材名称
．商品名称、全球医疗器材命名法
．产品代码、分类、组别
．产品内容、使用目的
．製造商名称、地址、国家
．产品质量标准
．有含药物的医疗器材：浓度、含量、最小包装、企业名称、地址、国家、详细资料(附加文件)
．ISO 13485品质管理认证书
．医疗器材拥有者的授权书
．资格保证证明书
．技术文件(包含：原材料、产品安全、生产规则、临床和临床前研究报告、稳定度报告、技术简介、越南文使用说明、标籤、目录等)
．自由销售证书
．样本
7. C类和D类侵入人体的医疗器材需要汇总临床试验数据。
8. 作为测量仪器的医疗器材需要额外的文件，例如由科技部负责的样品批准、检验和校准。
9. 缴费、提交资料
10. A、B类由所在省的卫生部门进行快速行政审查，经批准后具有终身有效性。C、D类由医疗设备和卫生工程部（DMEHW）批准，A、B、C、D类註册号终生有效。。
C、D 类医疗器材符合下列一种情况，可採快速註册通道
1. 已获得获下列任意一个机构核发之自由销售证明(CFS)或市场授权书（Market Authorization）：
．美国Food and Drug Administration (FDA)
．澳洲Therapeutic Goods Administration (TGA)
．加拿大卫生部
．日本厚生劳动省或Pharmaceuticals and Medical Devices Agency
．欧盟成员国、英国及瑞士
．中国National Medical Products Administration
．韩国Ministry of Food & Drug Safety
．其他越南政府认可的机构
2. 已获得由越南政府核发之进口许可证、註册号、或CFS。
标籤
进口越南的医疗器材商品标籤的强制性内容必须用越南文书写，标註以下内容：
1. 企业名称和地址
2. 商品名称
3. 原产国、製造商名称和地址(生产货物的国家或地区的名称不得缩写)
4 进口商名称、地址
5. 型号名称
6. 流通编号或进口许可证编号
7. 批号或序列号
8. 生产日期、有效期（灭菌或一次性医疗设备、试剂、校准物质、控製材料、化学品需要有效期）
．按日曆年的日、月、年的顺序记录，如果以不同的顺序书写，则必须用越南语对该顺序进行说明。
．每个表示日、月、年的数字以两位数记录，年指示符允许以四位数字书写，表示日期的日、月和年的数字必须在同一行。
9. 技术规范、警告信息
10. 使用说明
11. 存放说明
12. 保修条件
13. 某些低风险设备的使用说明 (IFU) 和软件标籤可以线上提供。
14. 成分、定量成分
15. 其他内容
注意
1. 商品标籤上书写的字母、数字、图画、图像、标誌和符号的颜色必须清晰。对于规定的强制性内容，字母和数字的颜色必须与商品标籤的背景颜色形成对比。
2. 以下内容允许用拉丁字根的其他语言书写：
．人类使用药物的国际名称或学名(如果没有越南名称) 。
．国际名称或学名连同该药物的化学式、结构式、活性成分、赋形剂和成分。
．成分的国际名称或学名、货物的定量成分，以防无法翻译成越南语或翻译成越南语但没有意义。
．参与货物生产的外国企业的名称和地址。
3. 辅助标籤必须贴在商品或商品的商业包装上，不得遮挡原标籤的强制性内容。
4. 商品标籤责任
．负责对商品进行标註（包括辅助标籤）的组织和个人，必须确保标註真实、清晰、准确，反映商品的真实性质。
．进口商投入流通时必须保留原标籤。
．商品标籤不得显示与主权争端有关的图像和内容以及其他可能影响越南安全、政治、经济、社会、外交关係习俗和传统的敏感内容。
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)
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.
【参考连结】
https://dmec.moh.gov.vn/tai-lieu-huong-dan-su-dung
HLF-VN-45
请问在越南有哪些专业服务机构，可以协助办理医疗器材产品许可证？
HLF-VN-50
外国公司可以用自己名义申请办理产品许可吗？如需要，哪个单位在管理？需要什麽文件？申请程序为何？医疗器材包装内容及各种标示，需要事先核准吗？可允许的语文有哪些？？网页？
Can a foreign company apply for a product license by its own name? If yes, which authority is in charge? What documents are required? What is the application process? Do medical devices packaging and labeling require prior approval? Which languages are allowed?? Website?
需以越南当地公司名义取得市场授权 (MA) 许可证。
医疗器材的市场授权 (MA) 许可证只有在越南当地註册的有效公司才能註册医疗器材，并且必须声明医疗器材符合标准。
1. 于医疗器材管理在线公共服务系统网站(DMEC)完成企业註册
2. 企业资料
．公司/企业名称
．代表号或税号
．地址、区域
．电话、传真号码、网页(如果有)、电子邮件
3. 企业法定代表人资料
．姓名
．身分证字号
．电话
4. 保修地址、电话
5. 签署承诺书
6. 医疗器材详细资料
．医疗器材名称
．商品名称、全球医疗器材命名法
．产品代码、分类、组别
．产品内容、使用目的
．製造商名称、地址、国家
．产品质量标准
．有含药物的医疗器材：浓度、含量、最小包装、企业名称、地址、国家、详细资料(附加文件)
．ISO 13485品质管理认证书
．医疗器材拥有者的授权书
．资格保证证明书
．技术文件(包含：原材料、产品安全、生产规则、临床和临床前研究报告、稳定度报告、技术简介、越南文使用说明、标籤、目录等)
．自由销售证书
．样本
7. C类和D类侵入人体的医疗器材需要汇总临床试验数据。
8. 作为测量仪器的医疗器材需要额外的文件，例如由科技部负责的样品批准、检验和校准。
9. 缴费、提交资料
10. A、B类由所在省的卫生部门进行快速行政审查，经批准后具有终身有效性。C、D类由医疗设备和卫生工程部（DMEHW）批准，A、B、C、D类註册号终生有效。。
C、D 类医疗器材符合下列一种情况，可採快速註册通道
1. 已获得获下列任意一个机构核发之自由销售证明(CFS)或市场授权书（Market Authorization）：
．美国Food and Drug Administration (FDA)
．澳洲Therapeutic Goods Administration (TGA)
．加拿大卫生部
．日本厚生劳动省或Pharmaceuticals and Medical Devices Agency
．欧盟成员国、英国及瑞士
．中国National Medical Products Administration
．韩国Ministry of Food & Drug Safety
．其他越南政府认可的机构
2. 已获得由越南政府核发之进口许可证、註册号、或CFS。
标籤
进口越南的医疗器材商品标籤的强制性内容必须用越南文书写，标註以下内容：
1. 企业名称和地址
2. 商品名称
3. 原产国、製造商名称和地址(生产货物的国家或地区的名称不得缩写)
4 进口商名称、地址
5. 型号名称
6. 流通编号或进口许可证编号
7. 批号或序列号
8. 生产日期、有效期（灭菌或一次性医疗设备、试剂、校准物质、控製材料、化学品需要有效期）
．按日曆年的日、月、年的顺序记录，如果以不同的顺序书写，则必须用越南语对该顺序进行说明。
．每个表示日、月、年的数字以两位数记录，年指示符允许以四位数字书写，表示日期的日、月和年的数字必须在同一行。
9. 技术规范、警告信息
10. 使用说明
11. 存放说明
12. 保修条件
13. 某些低风险设备的使用说明 (IFU) 和软件标籤可以线上提供。
14. 成分、定量成分
15. 其他内容
注意
1. 商品标籤上书写的字母、数字、图画、图像、标誌和符号的颜色必须清晰。对于规定的强制性内容，字母和数字的颜色必须与商品标籤的背景颜色形成对比。
2. 以下内容允许用拉丁字根的其他语言书写：
．人类使用药物的国际名称或学名(如果没有越南名称) 。
．国际名称或学名连同该药物的化学式、结构式、活性成分、赋形剂和成分。
．成分的国际名称或学名、货物的定量成分，以防无法翻译成越南语或翻译成越南语但没有意义。
．参与货物生产的外国企业的名称和地址。
3. 辅助标籤必须贴在商品或商品的商业包装上，不得遮挡原标籤的强制性内容。
4. 商品标籤责任
．负责对商品进行标註（包括辅助标籤）的组织和个人，必须确保标註真实、清晰、准确，反映商品的真实性质。
．进口商投入流通时必须保留原标籤。
．商品标籤不得显示与主权争端有关的图像和内容以及其他可能影响越南安全、政治、经济、社会、外交关係习俗和传统的敏感内容。
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)
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.
【参考连结】
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
请问在越南有哪些专业服务机构，可以协助以外国公司名义办理医疗器材产品许可证？
>HLF-VN-60
经过核准登记的医疗器材，进口到越南要检附什麽文件？经过什麽手续？在销售时要向各地的卫生福利部相关机构事先或事后准备吗？网页？
What documents are required when importing approved medical devices into Vietnam? What is the procedure? Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?
Evershine RD：
需要以越南当地公司名义申请进口许可证。
进口商必须满足以下条件：
1. 拥有越南企业法、合作法或投资法规定的充分法律文件。
2. 具有满足下列条件的技术人员和物质基础
．首席技术员必须具备以下学历之一： 医学生物电子学大学学历；大学技术文凭；医学或药学大学文凭和合法医疗器材培训机构颁发的医疗器材专业培训证书或国外颁发的同等证书，培训时间不少于1个月。
．具有上述学历，并经所在单位负责人认证直接在医疗机构工作或管理医疗设备3年以上的人员，可免取得医疗设备专业培训证书。
．有能够指导贸易商经营的医疗器材安装、维修的技术干部和人员（每年接受器材生产企业培训）。
．有总部、适当的仓库，满足良好保存医疗设备的条件，有足够的工具、技术设备和设施进行医疗设备的安装、维护；有足够的防火、防爆和灭火设备，必须按照法律规定确保环境安全和卫生。
3. 越南境外的公司都不能以自己的名义持有进口许可证或产品註册。申请和持有许可证者必须是在越南註册和经营的公司实体。
进口许可证申请
1. 医疗器材进口许可申请书。
2. 证明符合资格的相关文件。
3. 随附的文件，包括
．各类设备的目录（原件）
．生产商 ISO-9001、ISO 14000 或同等质量控制证书
．产品在生产国流通的许可证
4. 资料必须完整送至卫生部 医疗设备和卫生工程部 ( DMEHW )并提交卫生部科学技术委员会审议和授予进口许可证。
5. 获得许可的进口商必须按照财政部的规定支付费用。
6. DMEHW 通常会在收到申请文件后的 15 个工作日内授予进口许可证，除非需要进行临床试验。
7. 可以接受外国临床试验结果，但必须已被外国医疗监管机构接受并在原产国註册医疗器材。此外，卫生部科学技术委员会必须审查和批准外国临床试验结果，如果卫生部决定还必须在越南进行临床试验才能获得批准的产品，卫生部将自行组织和进行试验，通常需要在三个或更多医院进行，试验可能需要 3 到 12 个月才能完成，在某些情况下甚至更长时间。如果需要进行临床试验，但在越南境内外未进行过试验，DMEHW 将安排由申请人负责准备临床试验方案。在试验结束时，医院会将结果传回给 DMEHW 和申请人。然后申请人应重新提交申请并附上试验结果，DMEHW 将在另外 15 个工作日内发布。
海关
1. 所有进口到越南的货物都必须申报并徵税，除非货物符合免税或税收保护的条件。贸易商可通过国家单一窗口或越南自动清关系统 (VNACCS) 提交所需信息、电子报关单。进口税医疗器材通常为 0%，增值税医疗器材为 5%。
2. 进口商需自到货之日起30日内通过VNACCS系统提交完整无误的电子报关单、运输单证信息（如提单等）。
3. 申报报关提交文件
．已签署的报关单（原件）
．商业登记证複印件
．授权书原件或公证副本
．原产国的自由销售证明
．商业发票（複印件）
．销售合同（複印件）
．定期提单或空运提单
．货物清单（如有）
．原产地证书（C/O）
．装箱单
．价值声明（如有）
．收据（如有）
．原产地证书（如有）
．卫生和安全性之文件
．医疗器材进口许可证
4. 按规定缴纳税费，接收清关信息。
5.报关单内容
．报关登记海关分部
．提交日期和时间
．註册日期和时间
．进口口岸海关分局
．申报附件数量
．出口商、类型
．商业发票
．许可证号
．合同
．进口商
．提单（编号/日期）
．装货港、卸货港
．受託人/委託人
．运输工具
．出口国
．报关员
．到货日期
．交货条件
．付款方式、支付货币、税率
．商品说明、产品代码、项目、数量、价值等
5.仓储
．如果进口商不打算立即将货物投入越南流通，可以根据海关仓库储存制度进口到越南。商品入库时实行税收保护，商品投入流通时才徵收税款。
．贸易商在入库时需要提交保税仓储制度下的进口报关单，在货物进入流通时需要提交正规的进口报关单。
．仓库有多种类型（保税仓库、暂缓税仓库），带入仓库的货物必须得到越南海关总署或财政部的批准。
无销售许可证，但于产品许可证持有人在销售医疗器材前需要在DMEC价格申报门户网站上申报医疗器材价格。
1. 申请网页：https://kekhaigiattbyt.moh.gov.vn/
2. 必备资料/文件
．设备名称
．商品名称
．分类
．产品持有公司、代码
．製造商国家、公司
．单位
．包装
．配置、技术特性、附加服务
．进口成本或生产成本
．预期利润
．最高售价
．价格生效日期、价格有效日期
3.其他资料(非必须)
．获批流通编号/进口许可证资料
．代码全球医疗器材命名法(GMDN)
．设备图像
．设备类型：国产设备或进口设备
．附在成本价上的文件
．资本成本
．附在利润上的文件
．利润说明
．附在最高售价上的文件
．最高售价
．组件和配件的价格
．保修、维护、保养费用
．培训费用
．其他费用
4.可以逐笔输入，抑或下载excel档案批次上传(一次最多100笔)。
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).
【参考连结】
https://dmec.moh.gov.vn/dich-vu-cong/-/dvc/thutuchanhchinh/1117.html
>HLF-VN-70
越南医疗器材审核机构，需要附上的实验室检验资料有哪些? 网页？
What are the laboratory inspection materials that need to be attached for verification? Website?
Evershine RD：
1.製造商具备ISO 13485认证
．一般要求(商业执照、许可证、相关证明文件等)
． 文件要求(ISO流程纪录、医疗器材纪录、质量控制程序、文件控制程序、质量目标、质量方针、质量手册、部门应用流程/表格、内部门审计纪录等)
．管理责任(部门、负责人及职责)
．资源
．产品实现
．基础设施
．风险管理
2.技术文件
．医疗器材产品说明
医疗设备说明(原材料、产品安全、生产规则、临床和临床前研究报告、稳定度报告、技术简介)、组件和附件清单（包括随附的化学品）、标籤上所述的用途/指示、用户手册（越南文）、禁忌症、警告和注意、发生特定的不良反应
．已在其他国家流通的产品信息（如有）
．在其他国家註册的名称（如有）
．医疗器材产品的安全/显着操作信息
3. 进口医疗器材产品在製造国的自由销售证明（CFS）
由进口国官方机构签发的自由销售证明，如果CFS使用的语言不是英语或越南语，则必须翻译成越南语。须以英文 A4 尺寸白皮书製作，并包含以下基本信息：
．签发 CFS 的机构名称
．委员、参考编号
．委签发日期
．授予 CFS 的产品和货物名称
．授予 CFS 的产品和货物的类型或组别
．製造商的名称和地址
．必须明确说明产品和货物是在生产国市场上自由生产和销售的。
． CFS 发行人的全名、签名、职务和 CFS 发行人的印章
4. 授权书
製造商授权进口商之委託书，如果委託书使用的语言不是英语或越南语，则必须翻译成越南语。
5. C类和D类侵入人体的医疗器材需要汇总临床试验数据、作为测量仪器的医疗器材需要额外的文件，例如由科技部负责的样品批准、检验和校准。
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.
【参考连结】
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
越南医疗器材审核机构，能够接受海外检验机构的检验资料吗？假如是的话，有些被认可的机构？网页？
HLF-VN-77
请问在越南有哪些医疗器材检验机构可以提供医疗器材检验服务？网页？
HLF-VN-80
外国子公司进口医疗器材后，如果委託越南的经销商销售，经销商需要医疗器材营业许可证吗？
假如医疗器材有品质瑕疵的话，外国子公司和经销商各自的责任为何？是连带责任吗？还是可以规范由外国子公司负责？
After a foreign subsidiary imports medical devices and entrusts a distributor in 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：
医疗器材的市场授权 (MA) 许可证只有在越南当地註册的有效公司才能註册医疗器材，并且必须声明医疗器材符合标准。
市场授权 (MA) 许可证持有人应当负责组织管理医疗器材投放市场纪录及不良事件处理，并完整保留下列文件：
1.医疗器材註册号核发申请书
．产品所有者向申请註册的组织发出的授权书
．产品所有人授予的保修资格证明，但产品所有人规定的一次性医疗器材或有文件证明该医疗器材不在保修期内的除外
．CFS 或上市许可
2.流通记录（註册号持有人为代表机构的，不要求保留该记录，但必须要求其授权的医疗器材进口单位履行该职责）。
3.不良事件、投诉和纠正措施的记录，表明医疗器材的名称、类别、数量和批号，特别是那些有缺陷或对用户不安全的。
4.医疗器材质量管理文件
．依照货物原产地法律规定製作的原产地证书
．医疗器材註册申请中载明名称的产品所有人或製造商出具的每批医疗器材的质量证明书
．医疗器材检查记录
．医疗器材维修、保养服务的技术文件，但产品所有者规定的一次性医疗器材或有文件证明该医疗器材不在保修期内的除外
．医疗器材的使用说明以越南语提供
．保修中心、条件、时间等信息，产品所有者规定的一次性医疗器材或有文件证明该医疗器材不在保修期内的除外
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
【参考连结】
https://dmec.moh.gov.vn/web/guest/thong-bao
HLF-VN-85
请问在越南有哪些专精于医疗器材销售与消费权益相关法律服务的业者？
Email：han4ww@evershinecpa.com
或
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