Late last year, Vietnam issued a new law updating and augmenting their 2016 Law on Pharmacy. The updated drug law will simplify some drug regulations and begin on July 1, 2025. On the product registration front, if the drug has been approved... Read More
Recently, The Asia Pacific Medical Technology Association (APACMed) released their position paper titled “Risk-based Change Management for Registered Medical Devices.” As noted in this paper, some Asian countries utilize risk-based methods for device changes, while others require change submissions no matter what... Read More
Vietnam’s Ministry of Health presented significant amendments to the pharmaceutical law to the National Assembly in June 2024. The 2016 Pharmaceutical Law, which succeeded the 2005 law, initially provided a transparent legal foundation for the pharmaceutical industry and aligned with global standards.... Read More
The Ministry of Health (MOH) recently released a third draft version of a decree to establish a legal framework for managing and developing medical data, creating a National Medical Database, and implementing electronic health records. This decree is open for public feedback... Read More
Vietnam’s Ministry of Health (MoH) has promulgated Circular 05/2024/TT-BYT, which details guidelines for acquiring pharmaceuticals, medical devices, and testing equipment through price negotiations. This move follows the 2023 Law on Tendering, effective since January 2024. Over 600 drugs and 4 medical devices... Read More
Vietnam is facing significant health challenges, including high rates of heart disease and cancer, as the country is experiencing a rapidly growing middle class and strong economic development. With over 97 million people, Vietnam’s demand for better healthcare services, including access to... Read More
In an effort to streamline and modernize its medical device regulations, Vietnam has recently implemented significant updates, aiming to enhance efficiency while ensuring the safety and efficacy of medical devices. Two key developments, Circular 10/2023/TT-BY and Decree #07 mark, substantial shifts in... Read More
Late last year, Vietnam’s MoH announced Circular 23/2023/TT-BYT which updated the 2018 drug labeling requirements. The new drug labeling law will take effect on January 15, 2024. However, there will be a transition period until January 1, 2025. Therefore, drugs imported or... Read More
1. Overview Established in 1945, the Ministry of Health (MoH) in Vietnam is a government agency tasked with overseeing and managing various aspects of public health and healthcare products. This includes pharmaceuticals, medical devices, preventive medicine, medical care and treatment, rehabilitation, traditional... Read More
A recent report by Bain & Company and APACMed (a MedTech trade association located in Singapore) has issued a report on Asian MedTech companies’ growing appetite for ESG initiatives. According to this report, the Asia region has doubled its ESG policies compared... Read More