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

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

Enacted in 2009, Indonesia’s current Law on Health (Law No. 36/2009) is due for a refresh. The government realized that the law has not maintained its relevance when it comes to health trends such as digital health, which refers to the provision of health services online (also commonly known as telemedicine). While regulations and policy blueprints, such as Ministry of Health (MOH) Regulation No. 46/2017 concerning National E-Health Strategies, have addressed these shifting trends, Indonesia’s main health legislation has proved inadequate in this regard. For this reason, the government began making plans for an update to the law, and the first draft Omnibus Health Law was published in March 2023. The law addresses digital health and other important issues in today’s health landscape, and it seeks to promote the use of locally made health supplies. The draft Omnibus Health Law represents a notable step forward, but in its attempt to govern and regulate all aspects of health, there are also some issues in the draft that may overlap with some existing government regulations, such as provisions on Halal certification, compulsory licensing of patents, and addictive substances. This article outlines some of the draft law’s key aspects as well as some potential issues. Digital Health In addressing the growing health trend of telemedicine, the draft law confirms, reinforces, and fills gaps left by Indonesia’s three main regulations concerning telemedicine. namely, MOHR No. 20/2019 concerning Telemedicine, MOHR No. 24/2022 concerning Medical Records, and Medical Council Regulation No. 74/2020 concerning Telemedicine (MCR No. 74/2020). One of these regulations, MOH Regulation No. 20/2019, allows health service facilities to provide telemedicine services to other health service facilities. This covers telemedicine services related to radiology, electrocardiography, ultrasonography, and telemedicine consultancy services—including those that reflect developments in science and technology. This is the only regulation concerning

On June 30, 2023, the Ministry of Health of Vietnam issued Circular No. 14/2023/TT-BYT stipulating the process and procedure for building bidding package prices for procurement of goods and services in the field of medical devices at public health facilities (“Circular 14”). Circular 14 took effect on July 1, 2023, and will be valid through the end of 2023. Circular 14 applies to the procurement of medical devices/equipment and their accessories, spare parts, and supplies, as well as related services of repair, maintenance, inspection, and calibration. Under Circular 14, there are three methods of determining the price of bidding packages: Collecting quotations provided by suppliers of goods and services in the field of medical devices. Surveying the winning bid prices of similar goods and services on the national bidding network system (https://muasamcong.gov.vn). Using the results of price appraisal of a competent state agency that conducts price appraisal, or a specialized price appraisal enterprise. Method (i) must be used first; the two remaining methods can be applied only after method (i) has been unsuccessful. If the investor/procuring entity uses two or more methods to determine the price of bidding packages, it can select the highest price that is suitable to its financial capacity and professional requirements. Circular 14 further sets out the specific step-by-step process to build prices for procuring products and services in the field of medical devices/equipment. Transitional Provision For bidding packages that have already approved a contractor selection plan before July 1, 2023, the approved contractor selection plan will be followed. For bidding packages for which a contractor selection plan has been submitted by the investor/procuring entity but the plan has not yet been approved, the competent person can decide on the approval of the submitted plan or can request the investor/procuring entity to rebuild the bidding