Cambodia imports a substantial amount of food products to meet its domestic demand. Most of these imported products are from nearby ASEAN countries, with Thailand, Malaysia, and Vietnam providing the bulk of these food imports. However, food products from markets further away are becoming more popular each year, including brands from Australia, Japan, China, the EU, South-Korea, and the US. Many food product owners and distributors do not realize that all types of prepackaged food products, including imports, require product registration before they are permitted to be sold in Cambodia. This usually requires an assessment against mandatory Cambodian Standards and local technical regulations. There are general Cambodian Standards that cover all types of prepackaged food products, as well as product-specific standards and regulations that may be applicable. Furthermore, any type of prepackaged food product sold in Cambodia must bear a Khmer language label that meets the minimum consumer information standards, and the Cambodian Standards. This label requirement is often overlooked, with many products on the market bearing only a foreign language label. Product Registration & Labeling Requirements Back in 2000, a Cambodian Standard on prepackaged food labeling was adopted, clearly mandating Khmer language labeling for all types of prepackaged foods. Unfortunately, this labeling standard was not widely adopted by the industry, and even today compliance is low. Low compliance, combined with a lack of widespread enforcement efforts, led to a misguided understanding that imported food products were not subject to any standards, did not require product registration, and were not required to bear Khmer language labeling. Recent legal developments related to consumer protection and food safety clarified several of these misunderstandings. For example, the regulations clearly state that all types of food product must meet the applicable standards and technical regulations, which is assessed through registration. The new Law

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

Practitioners from Tilleke & Gibbins’ Vietnam offices contributed content for the latest edition of the Practical Law Life Sciences Global Guide. The guide provides a comparative overview, in Q&A format, of laws and regulations on pharmaceuticals, medical devices, and other life sciences products in dozens of jurisdictions around the world. The Life Sciences Global Guide is divided into two sections: Regulation (see more details here) and Commercialization, which covers the following topics: Overview of the life sciences sector Pricing, government funding, and reimbursement: National health care system, price regulation and reimbursement Distribution and sale Cross-border trade and parallel imports Advertising to the public and engagement with patient organizations Advertising to healthcare professionals and organizations: Gifts and incentives and transparency and disclosure Patents: Conditions for patentability, registration, length of protection, infringement, international treaties Trademarks: Requirements, registration Competition law issues: Authorities and legislation, commercial contracts and competition law, licensing approvals and formalities Product liability: Regulators, medicinal product liability law, liable partners, defenses, product liability claims, remedies Practical Law, produced by Thomson Reuters, is the world’s leading legal know-how resource for business lawyers, publishing a huge range of guides covering hundreds of jurisdictions and practice areas. The full “Life Sciences Commercialization in Vietnam” section can be found on the Practical Law website.