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.

Vietnam’s current Law on E-Transactions was passed in 2005 and has been effective since March 1, 2006. This law is considered a framework law, developed based on the Model Law on E-Commerce of the United Nations Commission on International Trade Law (UNCITRAL). According to the Ministry of Information and Communications (MIC), over the past 17 years, the implementation and application of e-transactions has shown significant evolution in certain areas demanding high levels of international integration, such as banking and e-commerce, but has faced difficulties in other areas due to a lack of detailed guidance. In addition, with the strong growth and breakthrough development of digital technologies such as artificial intelligence, big data, biometrics, and blockchain, and in the context of the ongoing Industrial Revolution 4.0 and the development of digital government, digital economy, and digital society, the 2005 Law on E-Transactions has revealed its shortcomings. Therefore, the government of Vietnam has entrusted the MIC to take the lead in drafting a new Law on E-Transactions, which will replace the old 2005 law in order to meet the country’s development needs. Accordingly, the MIC published a Draft Law on E-Transactions (“Draft Law”) for public consultation from May 4 to July 4, 2022. The latest accessible version of the Draft Law at the time of writing is Version 4. The effective date of the Draft Law is still not yet determined, though this law is expected to be submitted to the National Assembly for its review and comments in October 2022 and approval in May 2023. The following are some key contents of the Draft Law: 1. Scope of Application Unlike the current law, which explicitly excludes certain areas such as the issuance of certificates of land use rights and marriage certificates from the scope of application, the Draft Law attempts

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

Observers in Vietnam were recently captivated by a trademark application filed by a famous singer, Truong Trieu Truc Lan (also known as Nathan Lee), for the mark “CAO THAI SON” for “real estate services” in Class 36, “entertainment and stage performances” in Class 41 and “restaurant services” in Class 43. “Cao Thai Son” is the real name of another famous Vietnamese singer. The application astonished the community not only due to Nathan Lee’s attempt to register another person’s name, but also because Nathan Lee and Cao Thai Son have a longtime rivalry, and after buying copyrights to many of Cao Thai Son’s hit songs, Nathan Lee’s registration of his rival’s own name has obviously deepened the animosity between the two. If this mark is exclusively granted to Nathan Lee, Cao Thai Son’s fans are worried that their idol could no longer use his own name in his performing career due to risks of trademark infringement. Their concern is not groundless in the context that protection of trademarks in Vietnam mostly depends on registration. Rights to non-registered objects, even well-known marks, are still rather difficult to obtain and enforce. However, the right to an individual’s name is a moral right, which cannot be bought, sold, transferred between living people, or inherited. Article 26 of Vietnam’s Civil Code affirms that individuals “have the right to have a full name (including a middle name, if any) … determined by the person’s first and last name at birth,” and that they “establish and perform civil rights and obligations according to their surname and name.” Thus, Cao Thai Son, as an individual, has the right to use his name in civil transactions. He can also use his name in his performances, regardless of whether the trademark “CAO THAI SON” is granted to Nathan Lee,