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
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
On February 10, 2025, the Food and Drug Administration (FDA) of the Philippines implemented an Over-the-Counter (OTC) payment system for all FDA applications and transactions. This initiative aims to streamline the payment process, providing greater convenience for stakeholders. Key Highlights 1. OTC Payment Availability and Appointment Requirement OTC payments will
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
On January 30, 2025, the Thai Food and Drug Administration (Thai FDA) issued new Change Notification Guidelines for Notified and Licensed In Vitro Diagnostic (IVD) Medical Devices. These guidelines outline updated regulatory requirements and take effect from January 15, 2025. The full announcement is available on the Thai FDA Official
The Medical Device Control Division has introduced an updated Change Notification System for medical devices in Thailand, effective January 15, 2025. The newly issued guideline regulates the increase or decrease of medical device items within the same medical device group without affecting their category classification. This guideline has been published
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