Vietnam Medical Device Regulation QA
Email: sgn4ww@evershinecpa.com
or
Contact us by WeChat or Skype or Whatsapp in the day-work-time of Vietnam (GMT+8)
The Engaging Manager from Headquarter
Ms. Judy Wang, CPA(Taiwan) Speaks in both English and Chinese.
WeChat: Judy_Evershine
skype: Judy Wang
HLF-TW-10
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：
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】
HLF-TW-20
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：
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.
【參考連結】
https://dmec.moh.gov.vn/tai-lieu-huong-dan-su-dung
HLF-TW-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-TW-30
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：
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
【參考連結】
https://dmec.moh.gov.vn/web/guest/thong-bao
HLF-TW-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？
Evershine RD：
Getz Healthcare
https://www.getzhealthcare.com/
TNT Medical
https://tntmedical.com.vn/en/home/
HLF-TW-40
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：
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.
【參考連結】
https://dmec.moh.gov.vn/tai-lieu-huong-dan-su-dung
HLF-TW-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？
Evershine RD：
Qualtech
https://www.qualtechs.com/zh-tw/
Cekindo
HLF-TW-50
Can a foreign company apply for a product license by its own name? If yes, which authority is in charge? What documents are required? What is the application process? Do medical devices packaging and labeling require prior approval? Which languages are allowed?? Website?
Evershine RD：
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.
【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-TW-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？
Evershine RD：
Qualtech
https://www.qualtechs.com/zh-tw/
Cekindo
HLF-TW-60
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：
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://dmec.moh.gov.vn/dich-vu-cong/-/dvc/thutuchanhchinh/1117.html
HLF-TW-70
What are the laboratory inspection materials that need to be attached for verification? Website?
Evershine RD：
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/thong-tu-24-2011-tt-byt-huong-dan-nhap-khau-trang-thiet-bi-y-te
HLF-TW-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？
Evershine RD：
TÜV
DQS
https://www.dqsglobal.com/en-hk/
HLF-TW-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？
Evershine RD：
SGS
BV
https://www.bureauveritas.vn/en
HLF-TW-80
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：
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-TW-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？
Evershine RD：
ANT
Baker McKenzie
VINY
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