Product registration is a crucial step for businesses looking to introduce their goods to this vibrant market. Our comprehensive article offers a deep dive into the essentials of product registration in Vietnam, from understanding the necessary procedures and documentation to ensuring compliance with local standards.
Whether you’re launching a new product line or expanding your existing offerings, this article is your starting point for navigating the complexities of the Vietnamese regulatory landscape. Discover the key steps and expert tips to successfully register your products in Vietnam and set the stage for business success in one of Asia’s most dynamic economies.
Investing in Vietnam? Check out InCorp Vietnam’s Product Registration Services
Medical Devices Registration in Vietnam
In line with Clause 1, Article 2 of Decree 98/2021/ND-CP, a medical device in Vietnam refers to any tool, apparatus, implant, material, in-vitro reagent software, or calibrator that meets certain specified conditions.
These devices, as defined, are designed for use by individuals, either alone or in combination, to achieve various medical objectives. These include diagnosing, monitoring, preventing, alleviating, or treating diseases. Additionally, medical devices can contribute to the investigation, modification, replacement, or support of anatomical structures or physiological processes. They are also employed in supporting or sustaining life, controlling conception, disinfecting other medical devices, and providing crucial information for monitoring, diagnosis, or treatment through the examination of specimens from the human body.
It’s crucial to understand that, as outlined in the decree, a medical device doesn’t achieve its primary intended action within or on the human body through immunological, pharmacological, or metabolic means. However, it may receive assistance from such means to enhance its functionality, aligning with the diverse purposes specified in Point a of the aforementioned clause.
This definition establishes the basis for the regulatory framework overseeing the registration process for medical devices in Vietnam, ensuring clarity and specificity in categorizing products within this critical sector.
With a population exceeding 95 million and sustained economic growth, the expectations and standards of the Vietnamese people are in a constant state of evolution. This dynamic environment has given rise to an escalating demand for healthcare services and medical products, which, unfortunately, often outpaces the current supply. Notably, local companies face challenges in manufacturing sophisticated medical equipment, resulting in a significant dependence on foreign-imported medical products.
In the Vietnamese market, characterized by profit margins ranging between 35 and 40 percent for medical devices and related products, there exists a lucrative landscape for foreign medical companies.
The responsibility for overseeing the product registration of medical devices in Vietnam falls under the purview of the Department of Medical Equipment and Construction (DMEC), operating within the Ministry of Health (MOH). The DMEC plays a pivotal role in ensuring that medical devices meet the necessary standards and comply with regulatory frameworks. It is also important to note that the registration requirements for medical devices in Vietnam are currently undergoing a state of transition.
Medical Devices ClassificationMedical Devices Classification
Following Article 4 of Decree 98/2021/ND-CP, the classification of medical devices in Vietnam is a crucial aspect of the regulatory framework. This classification is based on the perceived levels of potential risks associated with the design and manufacture of medical devices. There are distinct classes:
In the past, the determination of medical device risk classification in Vietnam was reliant on the assessment of a locally certified organization or individual. However, with the advent of new regulations, a significant shift has occurred in the classification process. Under the updated framework, the responsibility for classifying the risk level of a medical device now lies with the Registration Holder, who can include this classification as part of the overall application.
| DMEC FeeS / MA Licenses | Review Time | |
| Class A | VND 1 million (~US$43) | Immediate |
| Class B | VND 3 million (~US$130) | Immediate |
| Class C | VND 5 million (~US$216) | Target: 10 to 90 days Actual: 1 or more years |
| Class D | VND 5 million (~US$216) | Target: 10 to 90 days Actual: 1 or more years |
Medical Device Registration Process in Vietnam
The process for registering medical devices in Vietnam involves a sequential series of steps. Initially, the applicant or license holder determines the risk classification, with the issued result serving as a foundation for subsequent actions. Class A and B medical device registration applications are then submitted online to the local health department via the portal https://dmec.moh.gov.vn/. Post approval, a Notification of Applicable Standard is issued, which is valid for a lifetime. Conversely, Class C and D medical device applications follow a similar online submission process directed to the Department of Medical Equipment and Construction (DMEC).
Approval results in the issuance of a Circulation Registration Certificate which is also called a Product License. The same has no expiration date and has been effective for Classes C and D devices since January 1, 2023. Adherence to the guidelines outlined in Decree 98/2021/ND-CP is crucial, with registrants concurrently processing payments while uploading necessary documentation under the product’s classification and group. This structured approach ensures a systematic and transparent registration process in alignment with Vietnamese regulatory standards.
Read More: Mastering Medical Device Registration: Your Key to Success in Vietnam
Required Documents to Register Medical Devices
Registering a medical device in Vietnam necessitates a comprehensive set of legal and technical documents. Among the legal documents required are the Free Sale Certificate, SO 13485 certificate, and the Letter of Authorization. Each of these plays a crucial role in establishing the device’s regulatory compliance with legal standards.
On the technical front, essential documents include the Classification Result, offering insights into the risk level, a Technical Brief outlining device specifications, Instruction for Use in Vietnamese, ensuring accessibility to end-users, and thorough labeling to convey important information. For medical devices falling under Classes C and D, which are invasive in the human body, an additional requirement is the submission of a summary of clinical trial data.
Specifically for measurement instruments categorized as medical devices, there are supplementary requirements. These instruments must undergo sample approval, inspection, and calibration under the purview of the Ministry of Science and Technology, underscoring the need for precision and accuracy in these devices.
Collectively, this array of legal and technical documentation forms the foundation for a thorough and compliant medical device registration process in Vietnam, providing regulatory authorities with the necessary information to ensure the safety and efficacy of medical devices within the country.
Fees and Timelines of Vietnam Medical Devices Registration
For every submission related to medical device registrations and import licenses in Vietnam, non-tax fees are applicable, as regulated by Circular 278/2016/TT-BTC. In the case of class A and B devices, the registration application undergoes approval and signing by the local Department of Health where the registrant is based. Typically, this process takes approximately 7-10 working days for approval, reflecting a relatively swift timeline.
Conversely, class C and D products follow a distinct trajectory. The registration application for these categories is approved and issued by the Department of Medical Equipment and Construction (DMEC). The estimated timeframe for completion ranges from 6 to 12 months, initiated once the DMEC initiates evaluations, as outlined in the earlier stages of the registration process. This longer timeframe for higher-risk categories underscores the meticulous scrutiny and comprehensive assessments conducted by regulatory authorities to ensure the safety and efficacy of medical devices within the Vietnamese market.
Food & Beverage Registration in Vietnam
Vietnam stands as a highly appealing investment destination globally, offering stability in politics, strategic infrastructure development, continuous improvements in education, and dedicated efforts to bolster foreign investment. In this promising landscape, the Food & Beverage sector emerges as one of the most lucrative. The Vietnamese populace demonstrates a strong willingness to invest in food and drinks, not just for daily consumption but also for special occasions.
The dynamism of Vietnam’s F&B market positions it among the most attractive globally. Influenced by shifting consumer behaviors, increased mobility, growing affluence, and urbanization trends, Vietnam is anticipated to rank among the top three nations in Asia for food and beverage development.
Despite a profound love for locally produced goods, Vietnamese consumers exhibit an open-minded approach, readily embracing new and imported products. In the realm of Food Product Registration, Vietnam has instituted specific customs regulations to govern this aspect of the market.
Read More: Food & Beverage Industry in Vietnam: Market Overview and Investment Opportunities
Vietnam Food Labeling
In Vietnam, the labeling of food products is a mandatory aspect of distribution and sale, with certain exceptions for specific types of items. Notably, unpacked raw food, unpacked fresh food, and certain processed foods may be exempt from this requirement. For all other food items, a comprehensive label is essential, incorporating at least the following key information:
- Name of the food
- Name and Address of the Producer, Importer and Assembler
- Weight and volume
- Ingredients
- The country of origin
- Instructions on storage
- Instructions on usage
- Production date & expiration date
Food Product Registration: Self-declared or Declared
In Vietnam, enterprises and individuals engaged in the production and sale of food possess the option to either self-declare the quality and origin of their products or undergo a formal registration process. Self-declaration signifies a commitment by companies to take full responsibility for the safety and hygiene of their food products. This involves making public announcements on their websites, multimedia platforms, or at their corporate offices, assuring consumers of the safety standards adhered to.
However, certain food items, by their nature, require a more formal declaration process. Companies intending to sell these specific food products must register for Product Declaration with the Ministry of Health before introducing them to the market. Article 6 of Decree 15/2018/ND-CP outlines the distinction between self-declaration and registration for declaration, providing clarity on which food products fall into each category.
| Self-declaration | Registration for declaration |
| * Processed and Prepackaged Food * Food Additives * Food Processing Aids *Food Containers * Packaging Materials in Direct Contact with Food | * Health Supplement or Dietary Supplement * Food for Special Medical Purposes or Medical Food * Food for Special Dietary Uses * Dietary products for children up to 36 months * Mixed food additives with new uses, food additives that are not on the list of allowed additives or are not for the right users, regulated by MOH. |
Food & Beverage Products: Rules & Regulations
The Vietnamese food and beverage landscape currently witnesses 35% consumption of Western food, a trend propelled by the increasing presence of foreign brands and the expanding middle class. Importing food and beverages into Vietnam necessitates strict adherence to local food safety regulations.
For minor changes, like alterations in packaging size or label information, approval from the Vietnam Food Safety Authority (VFA) is mandatory. More significant changes may require a new Certificate of Conformity Declaration, emphasizing the importance of seeking specialist consultation to ensure regulatory compliance and avoid penalties or sanctions.
Importers are subject to specific requirements, including:
- Importers must compile the necessary documents for customs regulations and declaration.
- While E-customs registration is available, importers must first register through the Vietnam Automated Cargo and Post-consolidated System.
- Submission of declaration forms in advance or within 30 days of product arrival, with inspections categorized as simplified, ordinary, or strict based on the type of food and beverage.
- Obtaining a delivery order involves preparing documents such as a signed bill of lading, importer details, and seals, among others.
- Providing customs declaration results and settling value-added tax (VAT) and import tax payments.
The registration of food and beverages for import into Vietnam necessitates a thorough documentation process, tailored to the specific type of product. Key documents include:
- Certificate of Food Safety and Hygiene Standards: This certifies that high-risk products adhere to hygiene and safety standards, ensuring consumer well-being.
- Certificate of Good Manufacturing Practice: This certification confirms that the manufacturing site and methods comply with the requirements of good manufacturing practice, emphasizing quality control.
- Certificate of Analysis: This document certifies that comprehensive physical, chemical, and microbiological tests have been conducted in the country of origin, affirming product safety.
- Declaration of Conformity: This declaration confirms that products with potential risks align with the standards implemented in Vietnam, emphasizing regulatory compliance with local customs regulations.
For the distribution of products within Vietnam, producers are required to self-announce food safety quality and regulatory compliance to the Ministry of Health. The application dossier should include:
- Food Safety Data Sheet: Issued within the 12 months preceding self-declaration, specifying safety indicators prescribed by the Ministry of Health and conducted by a designated or ISO 17025-compliant laboratory.
- Product Samples
- Product Labels
- Enterprise Registration Certificate (ERC)
- Certificate of Free Sale or Health Certificate
- Product Profile
- Certificate of Good Manufacturing Practice (GMP)
Health Supplements Registration in Vietnam
Foreign investors find a lucrative opportunity in Vietnam’s expanding healthcare and medical equipment market. The country’s substantial healthcare spending, exceeding US$17 billion in 2019 and constituting 6.6 percent of the GDP, underscores its commitment to the sector. Projections from FitchSolutions estimate healthcare expenditure to reach US$23 billion in 2022, with an anticipated annual growth rate of approximately 10.7% from 2019 to 2024. Given the complexity of the process, having a trusted local guide with extensive experience in product registration becomes invaluable.
Classification of Health Supplements in Vietnam
Health supplements, also known as dietary or food supplements, play a vital role in enhancing health and boosting immunity. These products, designed to improve well-being, can take various forms, including pills, tablets, capsules, powders, liquids, and granules.
Aligned with their purpose, health supplements typically contain a range of substances, which can be singular or a combination of vitamins, amino acids, minerals, enzymes, fatty acids, probiotics, and other biologically active substances. Moreover, health supplements may include substances derived from minerals, plants, and animals in the form of extracts, concentrates, isolates, or metabolites.
Labeling of Vietnam Health Supplements
The labeling of health supplements in Vietnam follows a standard format akin to other food products. A comprehensive label affixed to the package of the health supplement should include the following mandatory information:
- Name of the product
- Name and address of manufacturer/responsible party
- Certificate of origin
- Composition of the product
- Quantity of the product
- Manufacturing date
- Shelf life
- Usage and preservation instructions
- Nutritional information
- Recommendation and warnings
Additionally, for health supplements, it is mandatory to include the title “supplemental foods” on the label.
Vietnam Health Supplement Registration Process
For producers and distributors aiming to enter the Vietnamese market with health supplements, the registration process involves the submission of either product self-declaration or product declaration registration to the Ministry of Health (MOH). The application dossier should encompass several key documents, ensuring regulatory compliance with legal standards. These documents include:
- Certificate of Free Sale or Health Certificate
- Licenses of a Vietnamese importer consisting of:
- Investment registration certificate (IRC)
- Enterprise registration certificate (ERC)
- Product samples
- Product label
- Certificate of Good Manufacturing Practices (GMP)
Claims of Vietnam Health Supplements
In the realm of health supplement product registration in Vietnam, claims play a pivotal role in addition to labeling, encompassing two distinct types: nutrient content claims and health claims.
Nutrient Content Claims: Nutrient content claims are reserved for health supplements that meet specific criteria. To be eligible for these claims, a product must fulfill the following conditions:
- Provide 10% or more of the Vietnamese Recommended Nutrient Intake (RNI), either per 100g or per portion.
- Include at least 15% of the concerned nutrient reference intake as part of the product’s composition.
Health Claims: Health claims apply to health supplements whose added substances comprise 10% or more of the Recommended Nutrient Intake (RNI). Importantly, making health claims necessitates supporting scientific evidence.
Conclusion
In the complex realm of product registration in Vietnam, foreign investors face both challenges and opportunities. Understanding and adhering to the regulatory framework is paramount for successful market entry.
As Vietnam’s market continues to evolve, investors can capitalize on the country’s economic growth and burgeoning consumer demands. A strategic and informed approach to product registration ensures not only compliance with regulations but also positions investors to contribute to and benefit from Vietnam’s dynamic marketplace.
In essence, by embracing the intricacies of the application process, foreign investors can pave the way for successful ventures and meaningful contributions to Vietnam’s growing and diverse economy.
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