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

On December 31, 2025, the government of Vietnam promulgated Decree No. 356/2025/ND-CP detailing and guiding the implementation of the new Personal Data Protection Law (PDPL) that was issued in June 2025. The new decree, like the PDPL, entered into force on January 1, 2026, with the previous Decree No. 13/2023/ND-CP on personal data protection ceasing effect on the same day. Some key points of the new decree include the following: Comprehensive lists of basic and sensitive personal data are provided, which will require companies to review again their existing documents and data type classification to ensure compliance. New timelines are established for responding to specific data subject requests. These timelines are more reasonable and longer than the previous 72-hour requirements. Additional consent guidelines are provided, prohibiting default consent or ambiguous instructions that confuse data subjects about giving or withholding consent. Mandatory content for data transfer agreements/clauses in particular cases is provided. This covers, among other things, (i) the legal basis for the transfer of personal data; (ii) responsibilities for personal data protection during the transfer and processing of personal data; (iii) responsibilities for ensuring the exercise of the rights of personal data subjects; and (iv) responsibilities for coordination and compliance of the parties in cases where violations of personal data protection regulations are detected. The qualifications and responsibilities of data protection officers (DPOs) and data protection departments include, among others, having been trained and fostered in legal knowledge and professional skills regarding personal data protection. There are no specific provisions governing the qualifications or requirements for organizations that provide data protection training or education. New mandatory templates and requirements are provided in relation to data processing impact assessment and data transfer impact assessment, and for cases in which companies need to re-submit assessments to the regulator. Stricter requirements are

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

On December 17, 2025, Laos’ Ministry of Industry and Commerce (MOIC) issued a notice introducing a new digital system that allows e-commerce businesses to obtain required certificates and licenses through an online, application-based platform. Notice No. 3988, which will take effect on February 1, 2026, introduces the E-Trust platform, a downloadable application that allows e-commerce businesses to remotely obtain acknowledgement certificates and business operating licenses. New Digital Registration Options Under the previous framework established by the Decree on E-commerce (2021), businesses were required to complete registration exclusively through paper-based submissions. The new system now offers businesses two registration options: Traditional paper-based process at the Division of E-commerce Management within the MOIC; or Electronic registration and renewal through the E-Trust platform. This change is expected to streamline procedures, reduce administrative burdens, and enhance accessibility for businesses operating outside Vientiane. The E-Trust platform facilitates compliance for both individuals and legal entities required to submit applications and renewals for required certificates and licenses. The development is particularly beneficial for businesses located in remote provinces, as it eliminates the need for physical travel and significantly accelerates processing times. Compliance Requirements and Penalties Businesses must obtain or renew the required certificates and licenses to avoid sanctions under the Decision on Fines and Other Measures for Violation of the Decree and Regulations on E-commerce (No. 2828/MOIC, dated November 11, 2025). Penalties for noncompliance may include monetary fines and other enforcement measures.