Regulatory Updates

Malaysia: Issuance of Second Edition Guidance on HIV Self-Test Kit (HIVST) Placement

On January 31, 2025, the Medical Device Authority (MDA) of Malaysia released the Second Edition Guidance Document (MDA/GD/0065) on the placement of HIV Self-Test Kits (HIVST) in the Malaysian market. This updated guidance document introduces several key revisions affecting regulatory requirements, performance evaluation, conformity assessment, registration, labeling, and post-market surveillance.

Thailand: Priority Track Supporting Policies for Medical Device Registration to Reduce Chronic Diseases

On January 22, 2025, the Medical Device Control Division (MDCD) of Thailand released an infographic outlining the Priority Track for medical device registration. This initiative aims to expedite the approval process for medical devices that contribute to the prevention and management of chronic diseases, including diabetes, hypertension, hyperlipidemia, cardiovascular diseases,

Thailand: Thai FDA Issues Guidelines for Medical Device Sellers

The Thai Food and Drug Administration (Thai FDA) has released new guidelines for medical device sellers operating in Thailand. Effective immediately, these guidelines outline the necessary steps for compliance with regulatory requirements, including obtaining a sale license where applicable. Key Steps for Medical Device Sellers Step 1: Determine Whether a

Vietnam: Enterprises Declaring Medical Device Prices at the Ministry of Health

On December 31, 2024, the Vietnam Ministry of Health issued Notice No. 638/TB-HTTB, announcing the list of enterprises declaring medical device prices at the Ministry of Health. The list has been compiled under the provisions of Decree No. 85/2024/ND-CP, dated July 10, 2024, which outlines detailed regulations in the Law

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