About MedGate
MedGate Medical Device Co., Ltd. is an independent regulatory and license-holding company focused exclusively on medical devices entering and operating in the Thai market with regulated medical device distribution services.
MedGate was established to address concrete and recurring gaps in the way regulatory, clinical, and market access services are traditionally delivered to medical device manufacturers. While many operators offer fragmented solutions, MedGate was created to provide an integrated and accountable model tailored to the real needs of manufacturers preparing for registration, local licensing, clinical activities, and controlled market distribution.
Why MedGate Was Created
Over the years, manufacturers entering Thailand have been required to coordinate multiple independent parties: regulatory consultants, local license holders, CROs, and distributors, often without clear accountability or alignment between regulatory and commercial strategies.
MedGate was developed in response to this structural inefficiency. The company was designed to operate as a single, coherent interface, capable of supporting manufacturers throughout the entire regulatory lifecycle while maintaining full compliance with Thai FDA requirements.
Built on Proven Regulatory Experience
Although MedGate is a newly established company, it is built on the operational experience of senior regulatory professionals and established operators with long-standing involvement in the Thai medical device sector.
This experience spans Thai FDA medical device registration, license holding, post-market compliance, and interaction with clinical research organizations. MedGate applies this expertise through a structured and transparent operational model, ensuring regulatory decisions are aligned with long-term market objectives.
An Integrated Turn-Key Regulatory Model
MedGate provides what it defines as a turn-key regulatory and market access model.
By turn-key, MedGate refers to an integrated framework that combines:
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Thai FDA medical device classification and registration
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Coordination for Clinical and CRO support in Thailand
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Distribution readiness under a controlled regulatory structure
All activities are managed under a centralized compliance strategy, ensuring continuity, traceability, and regulatory accountability at every stage.
Clear Boundaries, Clear Accountability
MedGate operates with clearly defined boundaries and technical regulatory reference.
The company does not act as a business development agent and does not provide generic distribution services. Distribution activities are limited exclusively to medical devices for which MedGate holds or manages the Thai FDA license, ensuring regulatory control and post-market responsibility.
This model allows manufacturers to operate in Thailand with clarity, predictability, and reduced regulatory risk.
Regulatory Partnerships and Technical Resources
MedGate collaborates with selected regulatory partners in Thailand and technical experts to support specialized activities and technical depth where required. These collaborations are structured to preserve MedGate’s independence while reinforcing regulatory robustness and technical credibility.