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Product Registration in Vietnam

Product registration in Vietnam is complicated, but it doesn’t have to be. Let us demystify product regulation compliance while you focus on your business’ success.
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How InCorp Vietnam Helps You Register & Import Products

Product Registration Made Easy

InCorp Vietnam provides licensing, product registration, and tax services to help you import and distribute your products to Vietnam. We also offer incorporation services so you can start the process without being in Vietnam.

Our comprehensive Product Registration experts can:
  • Act as local representatives to complete the product registration application on your behalf.
  • Offer advice and complete procedures for quality specification of products.
  • Translate documents and get them notarized.
  • Obtain safety licenses for qualified products for you, and file certificate extensions at relevant state agencies.
  • Conduct monthly and yearly tax reporting.

How to Register Medical Devices in Vietnam:
Rules & Regulations

In Vietnam, medical devices and their related products have a profit margin of between 35 and 40 percent.

All medical devices that enter the Vietnamese market must be registered prior to distribution. 

Importantly, both domestic and imported medical equipment must obtain a Marketing Authorization (MA) license and other administrative documents such as Good Manufacturing Practice (GMP) or a Certificate of Pharmaceutical Products (CPP). All classes of medical devices require a free sale registration dossier (CFS). 

Clinical trials are required for medical devices that have never been imported into Vietnam and provide a new feature or therapy. Foreign clinical studies are normally permitted; however, local clinical trials by the Ministry of Health may be requested in exceptional circumstances.

How to Register Food &
Beverage in Vietnam:
Rules & Regulations

Currently, 35% of Vietnamese food and beverage consumption is based on Western food, mainly because of the growing number of foreign food and beverage brands in the country and the expanding middle class. 

To import food and beverages into Vietnam, importers must strictly adhere to the regulations of food safety, stated by the local law. In case of minor changes, such as the size of the package and the information on the label, it is required to obtain approval from the VFA (Vietnam Food Safety Authority). Other changes may require a new Certificate of Conformity Declaration. A consultation with a specialist is necessary to avoid non-compliance that may lead to penalties and sanctions.

Import
Requirements

All importers must satisfy the following food and beverage import requirements:

  • Customs declaration by preparing a set of required documents
  • E-customs registration is available but importers must register through the Vietnam Automated Cargo and Post-consolidated System first
  • Declaration forms must be submitted in advance or within 30 days of product arrival. There are three types of inspection: simplified, ordinary, and strict, depending on the type of food and beverage
  • Get a delivery order by preparing documents such as a signed bill of lading, importing operator details, and seal, among others
  • Provide the customs declaration result and pay for the value-added tax (VAT) and import tax

Required Documents
for F&B Registration

Depending on the type of food and beverage that will be imported into Vietnam, the most common and important documents are:

  • Certificate of Food Safety and Hygiene Standards: to certify that high-risk products comply with the hygiene and safety standards
  • Certificate of Good Manufacturing Practice: to certify that a manufacturing site and the manufacturing methods fulfill the requirements of good manufacturing practice
  • Certificate of Analysis: to certify that proper physical, chemical, and microbiological tests have been performed in the country of origin
  • Declaration of Conformity: to confirm that products that have potential risks that can be harmful conform to the standards implemented in Vietnam

Additionally, to distribute their products in Vietnam, producers must self-announce food safety quality and compliance to the Ministry of Health. The application dossier should have:

  • The food safety data sheet is issued within 12 months before the self-declaration is made by a designated laboratory or a laboratory complying with ISO 17025; the datasheet must specify safety indicators prescribed by the Ministry of Health
  • Product samples
  • Product labels
  • Enterprise registration certificate (ERC)
  • Certificate of Free Sale or Health Certificate
  • Product profile
  • Certificate of Good Manufacturing Practice (GMP) (depending on the product)

How to Register Health Supplements in Vietnam:
Rules & Regulations

Vietnam’s healthcare spending in 2019 was estimated to be over $17 billion, accounting for 6.6 percent of the country’s GDP, according to FitchSolutions. Healthcare expenditure will climb to $23 billion in 2022 and can grow over 10% annually from 2019 to 2024. Having a trusted local consultant with extensive experience in product registration can simplify the process so you can maximize efficiency.
To register health supplements in Vietnam, investors must comply with several regulations and strict food safety and hygiene standards.

Required Documents for Health Supplement Registration

Producers and distributors entering the Vietnamese market must submit product self-declaration or product declaration registration to the Ministry of Health. The application dossier includes:

  • Certificate of Free Sale or Health Certificate.
  • Licenses of a Vietnamese importer consisting of the Investment Registration Certificate (IRC) and Enterprise Registration Certificate (ERC)
  • Product samples
  • Product label
  • Certificate of Good Manufacturing Practice (GMP)

Claims of
Vietnam health supplements

In addition to labeling, claims are also part of the requirements for health supplement product registration in Vietnam. There are two types of claims for health supplements, namely nutrient content claims and health claims, detailed below:

  • Nutrient content claims: Not every health supplement can have nutrient content claims. Only products that provide 10% or more of the Vietnamese RNI, either per 100g or per portion, can have the claims. Another factor is the main active ingredients. To be eligible for claims, a product must contain at least 15% of the concerned nutrient reference intake.
  • Health claims: Only health supplements whose added substances contain 10% or more of the RNI can have health claims. Scientific evidence is required to make such claims.

How to Register Cosmetics in Vietnam:
Rules & Regulations

With the growth of the Vietnamese middle-income population and higher purchasing power, high-quality, well-known cosmetics are booming in Vietnam. Even though Vietnam possesses abundant natural cosmetic raw materials, the Vietnamese cosmetic industry relies heavily on imported products. In fact, local brands account for 10% of the market. High-quality international brands are the most demanded products among young consumers and have a natural advantage in the market.

Required Documents for Health Supplement Registration

To register cosmetics in Vietnam, importers are required to proclaim their products. The proclamation dossier includes:

  • Proclamation report of cosmetics
  • Enterprise registration certificate
  • Power of Attorney from the producer/owner of the product
  • Product information file
  • Certificate of Free Sale

Entity Establishment
for Foreign Cosmetics Firms

Furthermore, foreign investors must establish a company responsible for registering and putting the products on the market. A certificate of free sale, product information file, product safety certificate, and several other licenses/documents should be presented to obtain a registration number.

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Frequently Asked Questions on Product Registration in Vietnam

The classification of medical devices in Vietnam is now based on a risk classification as opposed to the former division based on function classes.

  • Class A – lowest risk (e.g. bandages, surgical gloves)
  • Class B – low risk
  • Class C – high risk
  • Class D – highest risk (e.g, artificial organs, contact lenses)

The MOH’s Department of Medical Equipment and Health Works (DMEHW) is the regulatory organization that oversees the registration and licensing of all medical devices in Vietnam, as stated in Decree 36 and 39 (2019).
The registration is governed and approved by the Health Service Department for class A devices and the Ministry of Health (MOH) for class B, C, and D devices.

Every food that is distributed and sold in Vietnam must have a label on the outside, except for unpacked raw food, unpacked fresh food, and processed food. A food label should contain:

  • Food name
  • Name and address of the producer, importer, assembler
  • Weight & volume
  • Ingredients
  • Country of origin
  • Storage instructions
  • Use instructions
  • Production date & expiration

Food that is categorized as either functional, irradiated, genetically modified or contains additives must have this additional information on the label.

The labeling of health supplements is basically the same as labeling of other food types. In general, a label should be put on the package of the health supplement and contain the following mandatory information.

  • Name of product
  • Composition
  • Quantity of product
  • Manufacturing date
  • Usage and preservation instructions
  • Shelf life
  • Country of origin
  • Name and address of manufacture/responsible party
  • Nutritional information
  • Recommendation and warnings

For supplements, it is required to put the title “supplemental foods” on the label.

Health supplements, also known as dietary supplements or food supplements, are products used to improve the health and boost the immunity of their users.
Health supplements may come in various forms such as pills, tablets, capsules, powder, liquids, and granules. In line with its purpose, a health supplement contain the following substances (can be a single substance or a mixture of many):

  • Vitamins, minerals, amino acids, fatty acids, enzymes, probiotics, and other biologically active substances.
  • Substances derived from animals, minerals, plants in the form of extracts, isolates, concentrate or metabolites.

International cosmetics imported to Vietnam must be registered before entering the market. The whole process is managed by the Drug Administration of Vietnam (DAV) under the MOH through its safety regulations and certificates. Unfortunately, the process remains unclear as to the regulations change, which is expected from a developing country like Vietnam.

Clients are the Focus of Our Actions

  • barber mullan incorp vietnam
    Besides being understanding, patient and kind, InCorp Vietnam was extremely efficient and practical as well and guided me every step along the way.
    George
    Barber Mullan & Associates
  • hex trust incorp vietnam
    I’ve been working with InCorp Vietnam in Vietnam for over 1 year now, and I find them to be very "user friendly" to partner with, being quite tuned into the local market, thus offering us effective options for execution through efficient means of communication. If you’re in the market for setting up your new company in Vietnam with relatively smooth passage, then consider InCorp Vietnam.
    Marty Jetton
    COO, Hex Trust
  • family import export company incorp vietnam
    It was our pleasure to deal with InCorp Vietnam. Indeed, the company with its specialised team was at the highest level of professionalism in dealing with customers and was serious in providing assistance and advice. Many thanks to InCorp Vietnam and all the team members. I wish you lasting success in the years to come.
    Amer
    CEO, Vietnam Family Import Export Company Limited
  • belive incorp vietnam
    We had a great experience entering a new market with InCorp Vietnam. Professional and always there to help! 11 thumbs up!
    Latif Sim
    Founder, BeLive Technology
  • ryker company limited incorp vietnam
    InCorp Vietnam has been a great help in the incorporation of our company in Vietnam by providing useful information and clear explanation on complicated regulatory procedures. The team went the extra mile by helping us to clarify on other matters pertaining to Vietnam, and proactively helped us to liaise with the respective internal functions on our queries and responded promptly.
    Louis Koh Kay Boon
    CEO, Ryker Company Limited

Guides & Insights
for Your Vietnam Business Journey

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Vietnam Investment Law: What Foreign Investors Need to Know

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Comprehensive Immigration Guide for Foreign Investors in Vietnam

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Chief Executive Officer
Group Head of HR and Payroll Services

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Ian Comandao

Business Consultant Manager

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