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

December 22, 2017

New Guidance Released on Class B, C, and D Medical Devices in Vietnam

Subscribe to Updates

Vietnam’s Ministry of Health (MOH) has recently issued a very important notification and new regulations relating to the implementation of Decree No. 36/2017/ND-CP (Decree 36) on medical device management. The key notification was issued under Official Dispatch No. 7165/BYT-TB-CT dated December 14, 2017 (Dispatch 7165). The new implementing guidelines for Decree 36 were issued under Circular No. 46/2017/TT-BYT dated December 15, 2017 (Circular 46). These developments are crucial to the registration regime for medical devices in Vietnam.

Dispatch 7165

While not relating to Class A medical devices (which include, for example bandages, wheelchairs, reusable surgical instruments, medical gloves, etc.), Dispatch 7165 provides specific guidance on Class B, C, and D devices, as well as in vitro diagnostic (IVD) biologicals. Class B medical devices include items such as blood centrifuges, diagnostic ultrasound scanners, and infusion cannulas, while Class C medical devices include items such as diagnostic X-ray equipment, electrosurgical units, and urethral stents. Class D medical devices include items such as absorbable sutures, arterioscopes, implantable infusion pumps, dental implants, etc.

A marketing authorization (MA) license for Class B, C, and D medical devices will only be required from January 1, 2019 onwards. This means that the MA regime for Class B, C, and D medical devices will be delayed for one year from the original date set forth under Decree 36. This delay is likely spurred on due to the imminent delays in registering massive amounts of medical devices that have never been registered before, especially when infrastructure and proper resources need to be bolstered among the registration teams/office of the MOH to handle the huge workload. The early deadlines to register all devices were not practicable and were over-ambitious goals.

From now until January 1, 2019, some specific interim regulations set forth under the new Official Dispatch are as follows:

  • Class B, C, and D medical devices which were included in the enclosed annex of Circular 30/2015/TT-BYT dated October 12, 2015 on promulgating the importation of medical devices (Circular 30) will continue to be governed by the regulations of Circular 30. This means the MOH is allowing these devices to be imported and circulated in Vietnam, provided that these devices have import licenses as stipulated in Circular 30, and have been properly classified as Class B, C, or D medical devices by the authorized organizations.
  • For Class B, C, and D medical devices which are not included in the enclosed annex of Circular 30, the MOH will allow these devices to be imported and circulated in Vietnam, provided that they have been properly classified as Class B, C, or D medical devices by the authorized organizations. For smooth customs clearance, in practice, these devices may also need a letter from the Department of Medical Equipment and Construction (DMEC) under the MOH to confirm that the imported medical devices are not included in the enclosed annex of Circular 30.
  • The importation and circulation of IVD biologicals (e.g., microbiology reagents, histology reagents, etc.) require an MA license (as stipulated in Circular 44/2014/TT-BYT on drug registration) or an import license (as stipulated in Circular No. 47/2010/TT-BYT). IVD biologicals with MA licenses can be imported until the expiry date of their MA licenses. For IVD biologicals with import licenses that expire on December 31, 2017, their import licenses can be extended if the expiry date on their Letter of Authorization (LOA) remains valid after December 31, 2017 and the importer submits a written extension request for the import license to the DMEC, which will then review the request and approve the extension at its discretion.  

Circular 46

Circular 46, which was just released, provides long-awaited implementing guidelines to Decree 36 and will enter into effect on February 1, 2018.

The Circular specifically states that Class C and D medical devices that are put into the human body are exempt from the requirement to submit summaries of clinical testing data and clinical testing research results. These medical devices include (1) medical devices in Annex I of the Circular (e.g., peritoneal dialysis catheters, cannulae, introducers, etc.), and (2) medical devices which are freely sold and have obtained certificates of free sale from a competent body of any of the countries and organizations which are set forth in Annex II of the Circular.

Class C or D IVD medical devices (e.g., HIV blood donor screening equipment, HIV blood diagnostic equipment, plasma bags, etc.) are also exempt from the requirement to submit test results if such medical devices have been freely sold and have obtained certificates of free sale from a competent body of any of the countries and organizations which are included in Annex II of the Circular. Annex II countries include Japan, Canada, the United States, and various European countries.

The Circular also includes a list (i.e., Annex III) of Class B, C, and D medical devices which may be traded like other normal goods, and imposes no requirements on the establishments trading them to declare their eligibility to trade in medical devices.

Additionally, the MOH issued guidance on presenting technical summaries, and requirements and terminology for Vietnamese to English translations for the LOA. A sample LOA is also promulgated under the Circular.

Technical summaries and English LOAs which were signed before the effective date of the Circular (February 1, 2018) will continue to be used; companies are not required to re-prepare these documents.

Download Full Article
Related Professionals

Industries

Life Sciences

Practices

Regulatory Affairs

Location

RELATED INSIGHTS​ 

September 4, 2026
Blind boxes and collectibles have become increasingly popular, driven by the excitement of not knowing which character or design will be revealed until the package is opened. While most visible in the art toy market, the same concept is also used in the food industry. Confectionery, snacks, and other food products are sometimes sold with toys, character figures, cards, or other collectibles. A package might, for example, contain one of ten possible characters, with consumers knowing that an item is included but not which one they will receive. Some collections may also feature rare or “secret” items. For food businesses, however, adding a randomized toy or collectible involves more than a marketing decision. The food, the nonfood item, and the randomized mechanism may each raise different regulatory considerations in Thailand. Thai FDA Requirements for Nonfood Objects Packaged with Food The main food regulatory consideration is Ministry of Public Health Notification No. 310 B.E. 2551 (2008), which regulates food packaged together with things or objects that are not food. Under Notification No. 310, certain nonfood objects may be packaged together with food where they fall within specified exceptions, including objects that serve the following purposes: Maintaining the quality or standard of the food, such as a desiccant or oxygen absorber; Serving as a seasoning or as part of food preparation, such as chili powder sachets or seasoning sachets contained in instant noodle packages; or Functioning as an eating or food-preparation utensil, such as a spoon or fork included with instant noodles. Other nonfood objects that do not fall within these categories generally should not be placed inside the food container together with the food. Where a toy, collectible, or other nonfood object is intended to be sold together with a food product, businesses should therefore carefully consider the nature of
Read More
August 20, 2026
As part of its membership in Lex Mundi, Tilleke & Gibbins has released the latest edition of its Guide to Doing Business in Thailand, providing an overview of the legal, regulatory, and commercial considerations for companies establishing or expanding operations in Thailand. The 2026 edition offers practical insight into the country’s business environment, investment framework, and operational requirements. The guide covers a wide range of topics relevant to foreign and domestic investors, including: Investment incentives and promotion schemes Financial facilities and banking regulations Exchange controls and money transfers Import and export regulations Business structures and incorporation options Requirements for establishing a business Operational and compliance considerations Business cessation and insolvency procedures Employment and labor laws Taxation Immigration and visa requirements Prepared by Tilleke & Gibbins lawyers across multiple practice areas, the publication outlines key aspects of doing business in Thailand, including foreign investment restrictions, regulatory compliance obligations, corporate structures, employment requirements, and recent legal and economic developments affecting investors. The publication forms part of Lex Mundi’s Country Guides series, a global collection of jurisdiction-specific reference materials prepared by member firms around the world. Together, these guides help companies evaluate opportunities, compare regulatory environments, and plan international business activities across multiple markets. The full Guide to Doing Business in Thailand 2026 is available through the button below.
Read More
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