You are using an outdated browser and your browsing experience will not be optimal. Please update to the latest version of Microsoft Edge, Google Chrome or Mozilla Firefox. Install Microsoft Edge

October 25, 2016

Medical Device Regulations Updated in Vietnam

Subscribe to Updates
Vietnam Pharma Update

On May 15, 2016, shortly before the new Law on Pharmacy was adopted, the Vietnamese government issued Decree No. 36/2016/ND-CP on the management of medical devices (Decree 36). This decree took effect on July 1, bringing medical devices under uniform management. Previously, there were two separate systems of legislation—one for medical devices manufactured domestically and the other for imported medical devices. All domestically manufactured medical devices had to be registered and granted marketing authorization licenses (MA licenses) from the Department of Medical Equipment and Health Works (DMEHW) under the Ministry of Health before being circulated. Foreign medical devices, on the other hand, did not require registration but had to obtain import licenses from the DMEHW to be imported and circulated in Vietnam.

In practice, management via import license created difficulties for foreign medical device companies, because each shipment required a new license. In addition, only 49 types of foreign medical devices were included in the list of medical devices requiring an import license—other types were, by default, exempt. This led to difficulties for the competent authorities because they needed to continually update the list or risk omitting new medical devices which, by their nature, should be strictly managed.

Decree 36 appears to provide some improvements in management. Some of the changes brought about by the new decree include:

1. Medical devices will be managed based on the risks that they pose to patients, and other risks related to design and manufacturing, and will be classified into four types based on risk level, from type-A (lowest risk) to type-D (highest risk). This classification is harmonized with ASEAN regulations.

2. All medical devices will be managed through MA licenses. If a foreign medical device has been granted an MA license, such medical device can be freely imported into Vietnam without any import license or import quota, provided that the MA license is still valid. There are two different types of MA license:

  1. MA licenses for type-A medical devices use the receipt number of their quality declaration dossiers, and are valid indefinitely.
  2. MA licenses for type-B, -C, and -D medical devices use the numbers from their circulation registration certificates, and are valid for five years.

3. Representative offices of foreign medical device owners can be applicants for MA licenses of medical devices.

4. Type-C and -D medical devices, which invade the human body, must undergo clinical trials in Vietnam.

In addition, the decree sets out conditions for companies and individuals who provide technical advisory services in medical devices. This area was not previously mentioned in legislation.

Under the new decree, management of medical devices will be tightened, but the legislation system will be clearer and more systematic. Overall, companies operating in the medical devices industry should find it easier to conduct business in Vietnam.

Download Full Article
Related Professionals

Industries

Life Sciences

Practices

Regulatory Affairs

Location

RELATED INSIGHTS​ 

August 10, 2026
On June 17, 2026, Indonesia’s National Agency of Drug and Food Control (BPOM) issued BPOM Regulation No. 10 of 2026 on Nutritional Information on Processed Food Labels. The new regulation, which revokes three previous nutrition labeling regulations, introduces several notable changes affecting food and beverage manufacturers, importers, and distributors. These changes range from updated nutrient reference values and serving-size requirements to the introduction of the Nutri-Level front-of-pack labeling system for certain beverage products. Businesses operating in Indonesia should carefully review these developments and assess their products’ compliance with the new requirements during the transition period. Implementation of the Nutri-Level Labeling System To implement the recently issued decree on Nutri-Level labeling, BPOM Regulation No. 10 of 2026 stipulates the requirements to implement the Nutri-Level labeling system on the front-of-pack. Under the new framework, ready-to-drink beverages, powdered beverages, and liquid or solid concentrates are required to display Nutri-Level labeling on the front label of their packaging. The Nutri-Level labeling system classifies products into color-coded levels A through D based on their sugar, sodium, and total fat content. The applicable Nutri-Level is determined based on the lowest level measured in the assessment of sugar, sodium, and total fat content. For products classified as level C or D, the Nutri-Level label must be accompanied by information on the relevant sugar, sodium, and total fat content per 100 ml of the ready-to-consume product. Products classified as level A or B may either display only the Nutri-Level designation or display the Nutri-Level together with the relevant nutritional information per 100 ml. Minimum Vitamin and Mineral Content Required for Declaration BPOM Regulation No. 10 of 2026 introduces a stricter threshold for the declaration of vitamins and minerals in the nutritional value information section (ING). Vitamins or minerals may only be declared if they are present at a
Read More
August 10, 2026
The drug registration process in Vietnam will be simplified, particularly for foreign applicants, following the recent issuance by Vietnam’s Ministry of Health (MOH) of a new circular that is expected to reduce administrative hurdles. Circular No. 32/2026/TT-BYT on the registration of drugs and medicinal ingredients (Circular 32) was issued on July 29, 2026, and will take effect on October 1, 2026, replacing Circular No. 12/2025/TT-BYT. Key provisions of the new circular are discussed below. Five-Year Data Exclusivity and Five-Month Public Disclosure Framework Circular 32 updates data protection guidelines by explicitly referencing Article 128 of the amended Intellectual Property Law, which sets out that new drugs supported by clinical trial data submitted for the first time will be granted a five-year data exclusivity period from the date of the initial marketing authorization (MA) approval. Subsequent applications that rely on the originator’s protected data will not be eligible for approval from the date of submission of the originator’s registration dossier until five years after the first MA is granted. Furthermore, in accordance with the new regulations, the regulatory authority must publicly disclose information on subsequent applications five months before the granting of MA, providing originator companies with an opportunity to exercise and enforce their intellectual property rights. Simplified Requirements for Foreign Legal Documents Circular 32 expands the circumstances under which legal documents issued by foreign authorities are exempt from consular legalization and authenticity verification requirements. Specifically, such documents may be exempt if the Drug Administration of Vietnam (DAV) is able to verify their authenticity directly through official electronic means, including written confirmation or email correspondence sent directly to the MOH by the competent foreign authority, or publicly accessible English-language databases maintained by recognized foreign regulatory authorities. In addition, the new circular permits the submission of electronic notarized copies of legal documents
Read More
July 24, 2026
As food innovation continues to accelerate, manufacturers are increasingly introducing ingredients derived from new sources, produced using novel technologies, or lacking a significant history of human consumption. While these innovations create new opportunities for the food industry, they also raise important questions regarding consumer safety. For this reason, many jurisdictions, including Thailand, the European Union, Australia and New Zealand, Canada, and Singapore, require a premarket safety assessment for novel food ingredients before they can be placed on the market. The objective of this assessment is to ensure that each ingredient is safe for its intended use and level of consumption, does not present toxicological, allergenic, microbiological, or nutritional concerns, and will not mislead consumers. Scientific authorities typically evaluate the ingredient’s identity, manufacturing process, composition, specifications, anticipated dietary exposure, toxicological information, nutritional impact, and history of use before determining whether it can be marketed. Against this background, the Thai Food and Drug Administration (FDA) recently took an important step toward improving regulatory transparency by publishing, for the first time, a consolidated public list of substances that have successfully completed the Thai FDA’s safety assessment process, including substances determined to be novel foods and those determined not to fall within the novel food category. The list identifies the approved substances, the corresponding manufacturers or importers, approval dates, and the approved conditions of use. Although the publication does not change the existing legal framework governing novel food approvals, it provides businesses with greater visibility into the Thai FDA’s regulatory precedents and the types of substances that have previously been accepted through the safety assessment process. The full announcement is available on the Thai FDA’s website. As the list is now publicly available, it also provides useful insight into the types of substances that have successfully completed the Thai FDA’s safety assessment process.
Read More
July 24, 2026
For businesses in Thailand’s regulated industries, the problem of “too many licenses” is one of the most familiar hurdles to getting a product to market. Take a simple example: importing the materials necessary to sell teriyaki chicken skewers. To legally do this, a business may need approvals from several different agencies—separate permits for the chicken (Department of Livestock Development), the dipping sauce (Thai FDA), the wooden skewers (Department of Forestry), and other ingredients, each under a different authority. This kind of overlap is often cited to argue for a “regulatory guillotine”—a systematic review to cut outdated or duplicative rules that slow investment and business activity. The Facilitation of Licensing and Public Service Consideration Act B.E. 2569 (2026) (Licensing Facilitation Act 2026) is Thailand’s most significant response yet to that concern. This article looks at the Facilitation Act 2026 through a life sciences and regulatory affairs lens—what it may mean for the manufacturers, importers, and distributors of food, drugs, medical devices, cosmetics, and similar products who routinely deal with several regulators to bring a single product to market. The Super License: One Approval Standing in for Many The reform with the clearest potential for regulated-product businesses is the law’s “super license” mechanism, referred to as a “main license” in the statute. Once a business obtains the main license for a regulated activity, it is automatically deemed to hold all related sublicenses issued by other agencies for that same activity, provided the activity has been designated as eligible in the Government Gazette. The Licensing Facilitation Act 2026 also creates a central application center, allowing applicants to submit a single application and pay all relevant fees at one point of contact, with the center routing the application to each agency through a shared information system. The potential benefits of this for businesses
Read More