Laos’ Ministry of Health (MOH) has promulgated a regulation detailing registration and notification protocols for medical devices. Decision on the Registration and Notification of Medical Devices No. 1470/MOH will come into force 60 days after both the signing of the regulation (which already occurred in July) and publication in the Official Gazette, which has not yet been specified by the government. Registration of medical devices in Laos is mentioned in the country’s Law on Drugs and Medical Products No. 07/NA, dated December 21, 2011, but a registration procedure has not been put in place. There was only a separate requirement to furnish certain required documents when importing medical devices. Now, the decision outlines the registration and notification process for medical devices through the Ministry of Health’s Food and Drug Department (FDD), in line with the regulatory principles in the ASEAN Medical Device Directive of 2015, which Laos has ratified. Medical Devices in Laos The decision defines medical devices as any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material, or other similar or related article intended for any of the following uses in humans: Diagnosis, prevention, monitoring, recovery from, or alleviation or treatment of a disease; Diagnosis, monitoring, recovery from, or alleviation of or compensation for an injury; Replacement, modification, or support of anatomy or a physiological process; Supporting and sustaining life; Controlling or assisting in conception; or Disinfection and sterilization of tools and medical devices. Medical devices in Laos are given one of four classifications based on their level of risk: Class A – Low risk (e.g., rubber belts, cotton for medical purposes, nonwoven swabs, adhesive bandages) Class B – Low-moderate risk (e.g., neonatal suction equipment, surgical gloves, gastro-catheters) Class C – Moderate-high risk (e.g., endoscopic surgical equipment, anesthesia equipment, peritoneal dialysis equipment) Class D – High risk (e.g., cardiological catheters, craniotomy surgical equipment) Registration and Notification Imported and locally

Since the June 9, 2022, delisting of all parts of the cannabis plant according to the Narcotics Code, there has been an explosion of cannabis dispensaries operating in Thailand. The Department of Thai Traditional and Alternative Medicine (DTTAM) has issued more than 12,000 cannabis dispensary licenses to businesses in Thailand. A license allows a dispensary to sell cannabis flowers legally. In addition, the DTTAM requests the cooperation of dispensaries in submitting monthly reports about the sourcing, selling, and inventory of cannabis flowers. The DTTAM may suspend the selling license of dispensaries that fail to submit these reports. Apart from the enforcement duties and administrative acts of the DTTAM, the enactment of the laws and regulations pertaining to cannabis seemed to be drastically winding down. One of the reasons was that Thailand had delays in the process of forming a new government following the general election of May 14, 2023. These delays dampened Thailand’s thriving cannabis industry. In particular, the industry has concerns about the uncertainty of the nascent cannabis law. On August 11, 2023, the Narcotics Control Division of the Thai Food and Drug Administration (FDA) posted the Draft Regulation Re: Application for Approval and Approval for Manufacture, Importation, Exportation, Distribution or Possession of Narcotics under Category 5 (Extracts from Cannabis or Hemp Plants Only). This may be the first regulation that the newly formed government implements with regard to cannabis extracts. Unlike the DTTAM’s enforcement activities, the Thai FDA requests that a domestic manufacturer, importer, exporter, or seller of cannabis extracts apply for a license. The Thai FDA, as the authority, will consider granting a license only in the following cases: For medical benefits; For commercial or industrial benefits; For the benefit of medical or scientific analysis or research; and For use by the government for preventing and suppressing narcotics-related offenses. Nonetheless, there is currently

Cambodia recently tightened its trademark procedures by restricting the filing of separate single-class applications for a mark covering multiple classes, and tightening the deadline for filing affidavits of use or non-use. The latter requirement is especially consequential for existing registered trademark owners, as disregarding it could result in removal of the registered mark from Cambodia’s trademark registry. Multiple-Class Applications Cambodia’s Ministry of Commerce announced on August 1, 2023, that the Department of Intellectual Property Rights will now only accept a single application for a trademark covering more than one international class. This means that multiple-class applications are mandatory for applications covering more than one class. Previously, trademark applicants were allowed to file separate single-class applications for the same mark covering multiple classes. The new rule, which took effect immediately, aims to reduce unnecessary paperwork and facilitate the trademark registration process. Period for Filing Affidavits of Use or Non-Use On August 11, 2023, the Ministry of Commerce issued a notification stating that trademark registrants who miss the deadline for filing an affidavit of use or non-use will no longer be allowed to file an affidavit after the deadline or at the time of filing the trademark renewal, as had previously been allowed. This is in line with the Sub-Decree Concerning the Filing of an Affidavit of Use or Non-Use, which requires registered trademark owners to file an affidavit of use or non-use of the trademark within one year following the fifth anniversary of the mark’s registration or renewal. Importantly, the notification announces that registered trademarks will be removed from the registry if the trademark owner fails to file an affidavit of the mark’s use or non-use within the required time period. This announcement applies to both domestic registrations and international registrations made under the Madrid Protocol. Although the notification does not explicitly state an effective date, trademark owners would

On August 23, 2023, the Vietnamese government issued Decree No. 65/2023/ND-CP detailing and guiding the implementation of some articles of the 2022 Intellectual Property Law with respect to the establishment and protection of industrial property rights (“Decree 65”). Decree 65 took immediate effect upon issuance, replacing Decree No. 103/2006/ND-CP and a part of Decree No. 105/2006/ND-CP, and provides long-awaited, necessary guidance for implementation of the IP Law, which took effect on January 1, 2023. Some of the most critical provisions of Decree 65 include the following:   Establishment of Industrial Property Rights Procedures for Establishment: The procedures for the establishment of industrial property rights are set out in Decree 65, rather than in a lower-level circular. These include the procedures related to PCT applications for inventions and Madrid applications for trademarks, and the (newly added) procedures related to Hague applications for industrial designs. Decree 65 also provides the details of the procedure for security control of inventions, including an annex listing the technical fields deemed to affect national security. The decree confirms that registration certificates can be issued in electronic form and in paper form. However, hard copy registration will only be issued under explicit request in the application. It also provides various new forms, including application forms for patents, designs, integrated circuits, and geographical indications, among others. Right Holder, Content, and Limitation of Rights: Further details are provided on the rights and responsibilities of organizations and individuals who use geographical indications. Decree 65 also details the procedure for compensation of patent owners due to the delay in granting marketing authorization of pharmaceutical products, stipulated in Article 131a of the IP Law. Secret Inventions: Decree 65 provides details for identifying and processing patent applications for secret inventions as well as procedures for decodifying inventions filed as secret inventions. Amendment: Decree 65 makes clear that for amendment

Michael Ramirez, a counsel in Tilleke & Gibbins’ dispute resolution department, has contributed an article to a series on contractual terms in Asia from the Asian Business Law Institute. Previous articles in the series have looked at administrative and tax requirements and contract breach and remedy under Thai law. The article gives an overview of how extracontractual liabilities are treated under Thai law. It addresses issues related to contract negotiations, no-reliance clauses, entire agreement clauses, and concurrent liability. ABLI, which is based in Singapore, conducts legal research and dissemination in order to provide knowledge, guidance, and recommendations surrounding development of legal systems in Asia. The full article on extracontractual liabilities is available as a PDF through the button below.

On August 23, 2023, the State Bank of Vietnam (SBV) issued Circular No. 10/2023/TT-NHNN (“Circular 10”), suspending the implementation of certain provisions of Circular No. 06/2023/TT-NHNN (“Circular 06”) concerning the offering of onshore loans to customers by credit institutions, including commercial banks and foreign bank branches. (See our previous coverage of Circular 06 here.) Both Circular 06 and Circular 10 will take effect on September 1, 2023. Circular 10 re-allows three categories of loans that credit institutions were not allowed to provide under Circular 06, including: Loans for making or acquiring capital contributions or shares in other companies which have not yet been listed on the securities market or registered for trading on the unlisted public company market (UPCoM) system. Loans for paying capital contributions under capital contribution contracts, investment cooperation contracts, or business cooperation contracts for implementation of investment projects that fail to satisfy conditions for being put into business operation. Loans for financial reimbursement. This change is a result of the working session between Deputy Prime Minister Le Minh Khai and the Governor of the State Bank of Vietnam to consider loosening restrictions for loans to borrowers after the issuance of Circular No. 06/2023/TT-NHNN.

On August 21, 2023, the Central Bank of Myanmar (CBM) issued a public notice in local newspapers reiterating the rights and obligations associated with holding and exchanging foreign currency. The notice emphasized that foreign exchange-dealing license holders can perform foreign currency exchange business in the country with both cash and travelers’ checks. The permissible foreign currencies for sale at money changers include US dollars (USD), euros, Singapore dollars (SGD), Thai baht (THB), Malaysian ringgit, Chinese yuan, and Japanese yen. The CBM has regularly warned the public that internal residents can only possess amounts of foreign currency equivalent to USD 10,000 for up to six months from the date of receipt. Under the Foreign Exchange Management Law, internal residents are: individuals who have resided in or have had their main establishment in Myanmar for a period of at least 183 days during the preceding twelve-month period, with the exception of diplomatic personnel from foreign countries and foreign civil servants who carry out similar assignments; companies, organizations, and offices formed under any domestic law and companies, organizations, offices, and branches formed legally in Myanmar under any foreign law; and diplomatic or other personnel appointed by Myanmar in foreign countries. If foreign currency is not used within six months, it must be sold to and exchanged by licensed foreign currency exchangers at the official exchange rate (currently 1 USD to 2100 MMK) or deposited in a bank account. Anyone who possesses foreign currencies without permission or without the necessary license will be subject to penalties under the Foreign Exchange Management Law. For more details on foreign currency exchange in Myanmar, or on any aspect of the country’s financial regulations, please contact Tilleke & Gibbins at [email protected].    

Self-reporting of customs violations in Thailand is normally carried out at the ports. However, in 2020, the Customs Department launched a campaign called the One Stop Service Program (OSSP) for business operators to self-report issues relating to unpaid customs duty from a central location in Bangkok. The current extension of the OSSP, which has been extended several times over the past few years, is due to expire on September 30, 2026, although a further extension seems likely. The OSSP offers a number of benefits. As noted above, settlement of unpaid duties can be done centrally in Bangkok even though the customs clearance itself is performed at Thai ports. Crucially, the fine for unpaid duty can be waived or reduced, and there is no late-payment penalty, which would normally amount to 20% of the unpaid duty if there is an official assessment and the duty is not paid within 30 days. The surcharge is reduced from 1% to 0.25%–0.75% per month on the unpaid duty. Nevertheless, any value-added tax (VAT), VAT surcharge, and VAT penalty on the unpaid duty still apply. To participate in the OSSP, the following conditions must be met: The offense must be considered a false declaration charge (Section 202 of the Customs Act), such as one involving value, price, tariff code, tariff rate, privileges, or other similar issues. The business operator must have committed the offense without intending to evade duty or restrictions. The goods must not be prohibited or infringe intellectual property. The declarations must not be under investigation by any authority in Thailand. Applications to participate in the OSSP can be submitted to the Post-Clearance Audit Division of the Customs Department, and applicants must provide the necessary documentation, such as customs declaration forms, invoices, purchase orders, sales contracts, and other payment documents. The officers will review the documentation and verify the additional duty