Regulatory Updates

Vietnam: Decree No. 90/2026/ND-CP on Healthcare Administrative Penalties

On 30 March 2026, the Government of Vietnam issued Decree No. 90/2026/ND-CP governing administrative sanctions in the healthcare sector, replacing previous regulations, notably Decree 117/2020/ND-CP. The Decree has taken effect since 15 May 2026. For medical devices, Articles 71 to 80 establish administrative violations and penalties covering key activities across

Vietnam: Customs Strengthens Controls on Origin Verification and Product Labeling

On 16 June 2026, the Department of Vietnam Customs issued Official Letter No. 17552/CHQ-GSQL to reinforce inspection and enforcement activities regarding country-of-origin determinations, origin claims, and goods labeling for both imports and exports. This Letter is a pivotal directive for the Customs sub-department to significantly tighten origin and labeling management

Vietnam: Circular 12/2026/TT-BVHTTDL Implementation Guidelines for Advertising Law

On 22 May 2026, the Ministry of Culture, Sports and Tourism issued Circular 12/2026/TT-BVHTTDL detailing specific provisions of the Advertising Law and its implementing Decree. The Circular provides implementation guidance on the use of superlative terms in advertising, appraisal of advertising materials, and procedures for group advertising activities. Read the

Malaysia: Automated Re-Registration Pathway Launched in MeDC@St 2.0+

The Medical Device Authority (MDA) Malaysia has officially introduced the Automated Re-Registration Route within the MeDC@St 2.0+ platform. Effective 13 July 2026, eligible re-registration applications will transition to this automated pathway, significantly reducing regulatory processing times and streamlining market access while ensuring compliance with the Medical Device Act 2012 (Act

Malaysia: Transition to Fully Online Product Classification Application Process

The Medical Device Authority (MDA) Malaysia has announced the transition to a fully online Product Classification Application Process, effective 1 August 2026. Under this initiative, all product classification applications must be submitted through the newly introduced Online Product Classification Application System, replacing the existing Google Form submission method. This digital

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