On December 31, 2025, Vietnam’s Ministry of Health (MOH) issued Circular No. 57/2025/TT-BYT providing guidance on the classification of medical devices according to technical standards and quality requirements (Circular 57), applicable to procurement activities for medical devices in Vietnam. According to the MOH, the purpose of the classification is to establish a principle-based legal framework and regulations that enable purchasers to easily identify groups of medical devices aligned with their professional requirements and financial capacity. Some of the key stipulations of Circular 57 are outlined below. Basis for Determining Technical Standards and Quality Under Circular 57, the technical standards of medical devices are determined in accordance with Vietnamese laws on standards and technical regulations, through the following means: Certification of conformity with standards in accordance with Vietnamese laws on standards and technical regulations; Results of conformity assessment conducted by an internationally recognized conformity assessment organization or a legally established domestic or foreign conformity assessment organization operating in Vietnam; and Documentation evidencing compliance provided by the medical device owner. The quality of medical devices is determined based on whether the device has been approved for circulation by the relevant marketing authority of one or more jurisdictions. Classification of Medical Devices Circular 57 classifies medical devices into six groups (from Group 1 to Group 6) based on technical standards and quality. Medical devices subject to classification must simultaneously meet technical standards and quality requirements in accordance with professional specifications and user needs, and must be lawfully marketed in Vietnam. Medical devices manufactured in Vietnam may participate in all corresponding groups, provided they meet the technical standards required by the user and are lawfully marketed in Vietnam. Outlook Circular No. 57 will take effect on February 15, 2026, while the classification requirements will become effective on January 1, 2027. Holders of medical

The Intellectual Property Office of Vietnam (IP Office), with support from the Japan International Cooperation Agency (JICA), is drafting additional annexes to its Guidelines for Patent Examination, focusing on the examination of patent applications in the pharmaceutical and biotechnology sectors. The new annexes are expected to be officially issued in early 2026 as Annexes III and IV, following the successful issuance in 2023 of Annexes I and II addressing computer program-related inventions. The IP Office recently organized a seminar to gather feedback on the draft annexes from intellectual property representatives, academic institutions, research institutes, and other interested parties, emphasizing its intention to receive further constructive opinions to refine the guidelines for pharmaceuticals and biotechnology. Why These Guidelines Matter Patent examination in Vietnam has traditionally relied on the Guidelines for Patent Examination issued under Decision No. 487/QD-SHTT (2010), recently supplemented by Annexes I and II. While these documents provide a solid foundation, they do not fully address practical challenges in examining pharmaceutical and biotech inventions, particularly issues related to clarity, sufficiency of disclosure, enablement, features of function and utility, combination therapies, and inventions involving artificial intelligence (AI) applications in these fields. Annexes III and IV aim to close these gaps by introducing structured principles and illustrative examples. Guidance on Patent Specification Requirements Annex III provides detailed guidance on the requirements for patent specifications in pharmaceuticals and biotechnology, covering two main parts: Part A addresses sufficiency of disclosure, clarity of specifications, and consistency between claims and descriptions. Part B covers inventions related to Markush-type compounds, claims containing exclusion statements (disclaimers), and additional experimental data submitted during examination. The Guidelines outline specific disclosure requirements for subject matters such as compounds, formulations, pharmaceutical compositions, genes, polypeptides, proteins, vectors, transgenic organisms, modified organisms, and hybrid cells. Annex III emphasizes that disclaimers are not accepted

Food safety incidents can emerge without warning, requiring businesses to act swiftly to protect consumers and comply with regulatory obligations. Across Southeast Asia, Thailand, Vietnam, and Indonesia have each developed comprehensive food recall frameworks designed to ensure rapid removal of unsafe products from the market while holding businesses accountable for compliance failures. While these three jurisdictions share common objectives—protecting public health and ensuring food safety—each has crafted distinct regulatory approaches reflecting their unique administrative structures, enforcement priorities, and legal traditions. Understanding these differences is essential for food businesses operating in the region, as recall procedures, timelines, reporting requirements, and penalties vary significantly across borders. This guide, available through the button below, examines the food recall regulations in Indonesia, Thailand, and Vietnam, providing practical guidance on legal requirements, procedural steps, and compliance obligations in each market.

Attorneys in Tilleke & Gibbins’ regulatory affairs team have produced the Cannabis and Hemp Business Guide – Thailand, a primer on the rapidly developing cannabis industry in Thailand.