Vietnam: Regulatory Update on Goods Labeling under Decree No. 37/2026/ND-CP – February/March 2026

• 2026-04-02 02:37:23

Decree No. 37/2026/ND-CP introduces updated labeling requirements in Vietnam, replacing previous regulations. It strengthens and supplements the rules on mandatory label information, while also introducing additional provisions on electronic labeling and specific requirements for medical devices. Transitional provisions are included to support the continued use of previously compliant labels for a limited period.

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MALAYSIA: MDA Regulatory Updates – Requirement of Labelling Guidance Document ＆ HSA Verification Approvals – February/March 2026

• 2026-04-01 07:01:44

The Medical Device Authority (MDA), Malaysia, announces two key updates for medical device registration. The latest labelling guidance introduces e-labelling requirements, while conformity assessments conducted by Singapore's Health Sciences Authority (HSA) are now recognized through a verification-based process. These updates aim to streamline registration and ensure compliance for medical devices in Malaysia.

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South Korea: Medical Device Regulatory Update - MFDS Amends Approval, Notification, and Review Rules – January/February 2026

• 2026-02-25 04:14:57

The Ministry of Food and Drug Safety (MFDS) has amended the Regulation on Permission, Notification, Review, Etc. of Medical Devices, effective 26 January 2026. The revision expands acceptable clinical documentation, integrates Class II certification responsibilities, refines the regulatory framework for innovative medical devices, clarifies technical documentation requirements, and strengthens cybersecurity submission obligations for connected devices. These updates aim to enhance regulatory clarity, align with international standards, and improve the efficiency of approval and certification procedures in South Korea.

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