Regulatory Updates

Malaysia: Implementation of Medical Device Regulations on Compounding of Offenses

On January 15, 2025, the Medical Device Authority (MDA) will begin implementing compounding of offenses under the Medical Device Act 2012 (Act 737). This enforcement is based on the authority granted under Section 71 of Act 737 and the Medical Device (Compounding of Offenses) Regulations 2024, which were officially gazetted

Thailand: New Guidelines for Change Notification of Medical Device Item Addition or Reduction for Notified and Licensed Non-In Vitro Diagnostic Devices

On February 10, 2025, the Thai Food and Drug Administration (FDA) released updated guidelines for submitting change notifications related to the addition or reduction of medical device items for non-in-vitro diagnostic (non-IVD) medical devices. These guidelines outline the required documentation for various types of change requests and took effect on

Malaysia: Transition to Online Advertising Application Process in Malaysia

The Medical Device Authority (MDA) of Malaysia has announced that, starting March 1, 2025, all medical device advertisement applications must be submitted exclusively online via Google Forms. This transition aims to enhance efficiency, streamline submissions, and improve the applicant experience. Key Changes in the Application Process Mandatory Online Submission Beginning

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