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

What does “digital health” include within each jurisdiction? Thailand: For the most part, the idea of “digital health” or “telemedicine” has generally fallen within the area of medical device regulation in Thailand. The normal sort of digital health components you would think of—like software and device accessories for diagnosis, monitoring, prevention, or treatment of illnesses—would fall into medical device classification, so long as they do not achieve their intended function by immunological, metabolic, or pharmacological means. The “digital health” devices you commonly think of, like mobile medical apps, wearable technologies and software, fall mainly within this definition. After the last update to the Medical Device Act in 2008, Thailand next looked at digital health in 2019, with the Personal Data Protection Act (PDPA)—which is largely aligned with GDPR principles—and the Cybersecurity Act. These deal with important issues arising from “digital health” and “telemedicine” like personal data protection, consent to use and consent to transfer data, and privacy. Vietnam: Similarly, in Vietnam, while there’s not a clear definition of “digital health” in the law, it is understood to include various types of medical devices, software, and online services used for healthcare purposes—including diagnosis and treatment as well as medical records and telemedicine. There’s no law on digital health, per se, but many of these areas are covered by separate circulars issued by the Ministry of Health. There’s a circular (referred to as “Circular 49”) from late 2017 on telemedicine, for example, that actually uses the term “telemedicine” to identify the industry and sets out licensing and technical requirements. Indicators such as this show that Vietnam is definitely embracing the concept. Indonesia: In Indonesia, there is also no precise definition of “digital health.” Digital health is regulated under several laws and regulations, such as provisions concerning medical devices under the health

Patent is an essential piece of the amended Law on Intellectual Property (“Amended IP Law”), which was passed by the National Assembly of Vietnam on June 16, 2022, and will take effect on January 1, 2023 (except for the regulation on protection of experimental data for agrochemical products, which will take delayed effect on January 14, 2024). Among the amended and supplemented contents of the Amended IP Law, there are notable patent-related amendments to Article 60 on assessing the novelty of inventions and Article 96 on grounds for invalidating patent protection titles. We discuss these changes below. Secret Prior Art Under Article 60.1 A significant amendment to Clause 1, Article 60 of the Amended IP Law on the novelty of inventions is to broaden the scope under which an invention can be considered to have lost its novelty. For the first time in Vietnam, “secret prior art” –a patent application with an earlier filing date or priority date but published on or after the filing date or priority date of an examined patent application – is introduced as a prior art document. In the diagram above, at the time of filing of the A2 application, secret prior art A1 has been filed but not yet published, making it inaccessible to the public. At this point, only the A1 applicant and the IP Office are aware of the A1 application. Under the current provisions of the 2005 IP Law, as amended in 2009 and 2019, the A1 patent application is not eligible to be a prior art document when assessing the novelty of A2. However, based on the “first-to-file principle” and the principle of priority, the IP Office has still had other approaches to bar the patentability of an A2 patent application if there is such an A1 application. By