Accelerate market entry with AI-powered dossier compilation and local representation, all for a flat annual fee. Starting at $2,000 USD per year for the first device (excludes government fees). Includes dossier submission, in-country representation, translation, modifications, distributor authorization, and post-market support.
Thailand’s FDA introduced a 2026 electronic change notification system for medical devices, enabling license holders to submit post-approval amendments digitally. The platform supports updates such as labeling changes, manufacturer details, and device item lists. The system aims to streamline submissions, reduce paperwork, and improve tracking of regulatory updates for companies managing Thailand medical device registrations.
From launching AI-driven regulatory solutions to expanding our global footprint, it was a year of meaningful milestones and shared moments.
Explore articles and insights our team has published in leading media and industry platforms.
Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.
