Regulatory Updates

Vietnam: Updated Medical Device Risk Classification and Management Measure Requirements

On 30 June 2026, the Vietnam Ministry of Health (MoH) issued Circular No. 24/2026/TT-BYT on the determination of risk classifications and management measures for medical device products and goods, and amendments and supplements to certain articles of Circular No. 05/2022/TT-BYT detailing the implementation of several articles of Decree No. 98/2021/NĐ-CP

Malaysia: Implementation of Hologram Security Label for Medical Devices

On 5 August 2026, the Medical Device Authority (MDA) announced the upcoming implementation of the Hologram Security Label for registered medical devices. The initiative aims to strengthen post-market surveillance, improve product traceability, and help ensure the authenticity of medical devices available in the Malaysian market. The Hologram Security Label will

Vietnam: New Rules on Apostille Certification of Public Documents

On 23 July 2026, the Government of Vietnam issued Decree No. 293/2026/NĐ-CP, which provides regulations on the competence and procedures for issuing Apostille certificates for Vietnamese public documents, the receipt, use, and verification of Apostille certificates, and state management of the implementation of the Hague Convention of 5 October 1961

Vietnam and Korea: Strengthen Healthcare Regulatory Cooperation Through New MoU

On 22 April 2026, the Ministry of Health of Vietnam (MOH) and the Ministry of Food and Drug Safety of Korea (MFDS) signed a Memorandum of Understanding (MoU) to enhance cooperation in healthcare-related fields, including pharmaceuticals, food safety, cosmetics, and medical devices. Signed by MFDS Minister Yu-Kyoung Oh and Vietnamese

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