In late 2021, the government of Vietnam issued Decree 98 on the management of medical devices (Decree No. 98/2021/ND-CP dated November 8, 2021), which came into force on January 1, 2022. This is the primary legislation on medical devices in Vietnam. To provide necessary guidance and elaboration on the implementation of Decree 98, the Ministry of Health recently issued Circular No. 05/2022/TT/BYT dated August 1, 2022 (“Circular 05”), which took effect on the same day. The most notable aspect of Circular 05 is that it unifies, in a single legislative document, previous regulations on medical devices that were scattered in multiple circulars issued by the Ministry of Health (Circular No. 39/2016/TT-BYT dated October 28, 2106; Circular No. 46/2017/TT-BYT dated December 15, 2017, as amended by Circular No. 23/2021/TT-BYT dated December 9, 2021; and Circular No. 33/2020/TT-BYT dated December 31, 2020). The effectiveness of these circulars was terminated when Circular 05 took effect. Circular 05 sets out regulations and principles for the classification of medical devices, and adds or supplements the following lists: List of in vitro diagnostic medical devices (IVD) not subject to quality assessment by Vietnamese competent authorities when registering under the quick registration procedure. List of class B, C and D medical devices allowed to be traded as normal goods. List of medical devices required to be accredited for safety and technical functions before use. List of medical devices requiring import permit licenses. While Circular 05 does not introduce major changes to the previous regulations, the consolidation and up-to-date guidance on Decree 98 will simplify the task of registration and circulation for medical device companies doing business in Vietnam.

Cosmetics have become an essential feature of the modern lifestyle led by many consumers in Cambodia. Every day, a wide range of new cosmetic brands, variants, and formats enter the Cambodian market, catering to a growing consumer base. The market generally relies on the import of foreign cosmetic brands, making Cambodia an attractive market for overseas cosmetics companies, but local brands are on the rise as well. Alongside the significant growth of the cosmetics market in Cambodia, and the Royal Government’s continuing push to increase consumer protection in Cambodia, in 2022, the Ministry of Commerce (MOC) issued Prakas No. 0064 on the Requirements for Cosmetic Distribution (the Prakas). The Prakas applies to both locally manufactured and imported cosmetics, and both individual and businesses that trade in cosmetics. The Prakas aims to regulate cosmetics and cosmetic business activities, to ensure that cosmetics distributed in Cambodia are of good quality and safe for use.  The key points contained in the Prakas are summarized below. Legal Obligations for Trading Cosmetics Any person trading in cosmetics, including wholesale or retail, and those that offer cosmetics as gifts or for testing, must ensure that the products are safe and meet the legal labelling requirements. Anyone trading cosmetics must respect the Law on Consumer Protection, with the Prakas highlighting key aspects of that law and referring to the applicable penalties under that law. Online sellers of cosmetics must obtain an additional approval letter (for individuals) or a license (for legal entities) to operate an online business, issued by the MOC. In addition, they require a certificate for providing online services from the Ministry of Post and Telecommunications. Interestingly, the Prakas does not refer to the cosmetic business licensing required under regulations issued by the Ministry of Health. As the Prakas does not outright contradict these

The Ministry of Energy is preparing to open a bidding round for the right to explore and produce petroleum in three offshore exploration blocks in the Gulf of Thailand: Exploration Block Nos. G1/65, G2/65, and G3/65. Announced in April 2022 with an eye toward national energy sustainability and security, this is the first opportunity for exploration of new offshore areas in 15 years. The total area of the three exploration blocks is 35,164.01 square kilometers, and operations in the exploration blocks will be subject to the terms and conditions of the required production sharing contract (PSC). Under the PSC, the Thai government is entitled to receive royalty payments against profits, any applicable cost recovery, and profit petroleum. The government also has the authority to monitor the petroleum operations in collaboration with the successful bidder. On July 27, 2022, the Department of Mineral Fuels (DMF) held a conference for prospective investors in order to clarify general information regarding the petroleum bidding round. Currently, interested investors can request the right to enter the bidding-round data room located at the DMF by emailing [email protected] by September 2, 2022. To participate in the bidding round, interested investors must submit an application together with required documents to the DMF during the period of September 5–16, 2022. For further information on the bidding round, or on any aspect of energy law in Thailand, please contact Tilleke & Gibbins at [email protected] or +66 2056 5555.

Thailand’s Securities and Exchange Commission (SEC) has announced three new regulatory requirements, which primarily require digital asset business operators to provide investors with training or a knowledge test on cryptocurrencies and to disclose information about the quality of their service and IT usage capacity. The amended SEC notification detailing these new obligations was promulgated on July 1, 2022; however, the measures come into effect separately, as detailed below. Training or Testing on Cryptocurrency From August 30, 2022, cryptocurrency exchanges, brokers, and dealers must provide guidance and education to their clients on basic asset allocation suitable to their capacity. These types of digital asset business operators must also provide for training or a knowledge test on cryptocurrency. The content should at least cover cryptocurrency, blockchain technology, digital wallets, and an overview of the market and investments. The following types of clients are exempted from these requirements: Existing clients of the digital asset business operators before July 1, 2022; New clients of the operator who already have experience investing in cryptocurrency before using the service of the business operator; and Institutional investors, ultra-high-net-worth investors, and high-net-worth investors. If the clients are legal entities other than those mentioned above, their representatives or appointed persons are required to undergo training or testing. The training or knowledge test is a prerequisite to using a digital asset business operator’s services. Operators are not allowed to provide their services to clients who do not undergo training or testing. Disclosure of Service Quality and IT Usage Capacity From January 1, 2023, cryptocurrency/digital token exchanges, brokers, and dealers are required to disclose to the SEC information about the quality of their services (including any technological errors and complaints from clients), and their IT usage capacity. For more information about the latest SEC rules and regulations for digital assets,