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 device registration numbers are advised to proactively prepare documentation demonstrating compliance with technical standards and

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 applied to enterprises providing data processing services, including

Resolution No. 222/2025/QH15 dated June 27, 2025, of the National Assembly of Vietnam (the “IFC Resolution” – see our previous article) set out the foundational legal framework for the establishment and development of Vietnam’s first-ever International Financial Centers (IFC). In furtherance of this framework, on December 18, 2025, the government of Vietnam issued eight implementing decrees to provide detailed regulatory guidance and to operationalize the IFC Resolution in practice. The Eight Implementing Decrees: An Integrated Regulatory Ecosystem The new decrees governing the IFC include the following: Decree No. 323/2025/ND-CP on the establishment of the IFC. Decree No. 324/2025/ND-CP on financial policies applicable within the IFC. Decree No. 325/2025/ND-CP on labor, employment, and social security within the IFC. Decree No. 326/2025/ND-CP on land and environmental matters within the IFC. Decree No. 327/2025/ND-CP on entry, exit, and residence of foreign nationals in the IFC. Decree No. 328/2025/ND-CP on the International Arbitration Center of the IFC. Decree No. 329/2025/ND-CP on banking licensing, foreign exchange management, and anti-money laundering and combating the financing of terrorism (AML/CFT) within the IFC. Decree No. 330/2025/ND-CP on the establishment and operation of commodity exchanges within the IFC. Taken as a whole, these eight decrees translate the IFC Resolution into a coherent and fully operational legal regime governing the establishment, organization, and functioning of Vietnam’s IFC. Collectively, they demonstrate that Vietnam’s IFC framework is best understood not as a collection of isolated incentives, but as a deliberately designed and integrated regulatory system. The Legal Architecture of the IFC: Four Interlocking Pillars Read together, the decrees seem to be designed to address four core regulatory questions from the outset: (i) what the IFC is, from a legal and institutional perspective; (ii) who may participate in the IFC and what activities are permitted; (iii) how people, capital, and projects operate on a day-to-day basis within the IFC; and (iv) how disputes are resolved,

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 if they introduce new technical features, alter the nature of

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.

Thailand has granted ride-sharing platforms additional time to comply with new regulatory requirements, extending the compliance deadline to March 31, 2026 (replacing the previous deadline of October 2, 2025). The postponement was made official on December 18, 2025, when Thailand’s Electronic Transactions Development Agency (ETDA) published the second Notification Regarding Supervision of Ride-Hailing Platforms Classified as High-Impact Digital Platform Services under the Royal Decree on Digital Platform Service Businesses. The notification provides additional time for ride-sharing platforms and drivers to transition to full regulatory compliance. The extension replaces the effective date provision of the earlier notification and applies specifically to ride-hailing activities. Background The postponement responds to feedback from operators and driver groups regarding challenges converting private vehicles into legally registered public vehicles, including complex registration procedures, high compliance costs, and operational delays. The Department of Land Transport (DLT) is concurrently reforming its vehicle registration and driver verification processes to streamline operations. Given these issues, the Electronic Transactions Committee has deferred enforcement to provide an adjustment period for operators and drivers to meet compliance requirements. Ongoing Obligations While the effective date has been deferred, the substantive obligations imposed on ride-sharing platforms remain fully intact. Operators must continue preparing to comply with the additional duties applicable to high-impact digital platform services, beyond the general requirements under the digital platform services framework. Operators are expected to use the extended transition period to finalize operational and compliance readiness ahead of enforcement on March 31, 2026. Key focus areas include: Integration with DLT vehicle-registration systems Deployment of robust driver and passenger identity verification mechanisms Updates to platform terms of service, driver-onboarding standards, and internal operational policies Preparation for ETDA reporting obligations and future audit and review processes Next Steps While the postponement replaces the previous effective date with the new March 31, 2026, deadline, operators should anticipate increased regulatory scrutiny as the revised effective date

The Bank of Thailand (BOT) has released the Guidelines for Digital Fraud Management, which took effect on December 17, 2025, incorporating certain amendments to the draft guidelines issued in March 2025. These official guidelines aim for end-to-end digital fraud prevention, with a particular focus on mule accounts, to enhance trust and security in Thailand’s financial system. The guidelines apply to “financial service providers,” including: Financial institutions and special financial institutions under the Financial Institution Business Act; and Operators of Inter-institutional Fund Transfer System e-money services and e-fund transfer services under the Payment Systems Act. Besides commercial banks and e-money operators that offer fund-transfer services, other providers may adopt requirements based on risk proportionality and baseline standards set out in the guidelines (for instance, an e-money operator that does not offer e-fund transfer services could consider implementing a fraud monitoring and detection system according to the risk level of its service). The guidelines establish the following key requirements: Policy and oversight. Directors and senior executives of financial service providers must adopt appropriate “end-to-end” fraud management policies and KPIs to manage digital fraud, covering prevention, monitoring, detection, management, resolution, and support for affected customers. The fraud management policy must be regularly reviewed, and whenever there is a situation or change that significantly affects the efficiency of the fraud management. Any significant update to the policy must first be approved by the board of the financial service provider. The BOT also encourages providers to collaborate in establishing industry standards aligned with applicable laws and regulations to ensure consistency and best practices across the sector. Fraud management processes. Financial service providers must establish a clear framework for managing digital fraud throughout the customer lifecycle—from customer onboarding to service termination—covering at least the following processes: Know your customer (KYC) and customer due diligence (CDD): The KYC procedure must also include identification of

On December 11, 2025, Vietnam’s National Assembly issued Resolution No. 254/2025/QH15 (Resolution No. 254) to address practical difficulties encountered in implementing the Law on Land 2024. The resolution provides specific mechanisms and policies to resolve issues related to land allocation, land leasing, and conversion of land-use purposes, while also addressing land valuation principles, timing of information collection, and land valuation methods. The resolution takes effect on January 1, 2026. Key provisions affecting investors are discussed below. Land Use Terms for Transferred Investment Projects The National Assembly has addressed situations where the remaining term of a transferred investment project is insufficient for the transferee’s business or financial plans. Resolution No. 254, along with the Law on Investment 2025, introduces aligned regulatory solutions. Under the Law on Investment 2025 (4th version submitted to the National Assembly for promulgation), if an investment project implemented prior to March 1, 2026, has been transferred and the transferor holds a Land Use Rights Certificate, has fulfilled all land-related financial obligations, and is not subject to termination, the competent authority may determine a new operating term if the remaining operating term does not meet the transferee investor’s financial or business plan. This adjustment occurs when approving or adjusting the investment policy or issuing or amending the investment registration certificate. The revised operating term is calculated from the date of the approval or issuance and must not exceed the statutory maximum of 70 years for projects in economic zones and 50 years for projects outside economic zones. Resolution No. 254 also permits adjustment of the land use term for transferred investment projects involving land, provided that the transferee investor pays additional land rent in accordance with applicable law, thereby ensuring consistency with the Law on Investment 2025. Land Rent Payment Options Resolution No. 254 generally expands the right to choose the form of land