Andaman Medical is a global pioneer in the field of regulatory services, working tirelessly since 2013. We ensure the seamless execution of key processes for medical device registration, independent authorized representatives, importation, and managing post-market compliance in Southeast Asia.
Our focus is providing you with a hassle-free experience, so you can concentrate on what you do best - innovating and advancing your medical devices. With our comprehensive services, we take care of the red tape, enabling you to expedite your entry into new markets.
* Medical Device Registration: Our experts navigate the intricacies of medical device registration, eliminating challenges and mitigating risks associated with getting your medical device approved.
* Authorized Representative: We act as your third-party authorized representative, liaising with regulatory authorities on your behalf, ensuring your interests are always protected.
* Importation: Navigating the complex maze of import regulations can be daunting. We take this burden off you, ensuring your products move smoothly through customs and reach their destination on time.
* Post Market Compliance: Keeping up with post-market requirements & updates in regulations can be time-consuming and complex. We offer you peace of mind ensuring you stay ahead of the game and avoid regulatory pitfalls.
We're your strategic partner with in-house expertise, prompt communication, and innovative solutions that save you time and resources.
Since opening our office in 2013, we have established ourselves as a leading provider of regulatory services, exclusively on medical devices. We're committed to upholding the highest standards of professionalism and integrity, and our proven track record speaks to this commitment.
Experience the Andaman Medical difference - where your success is our mission.
We invite you to reach out today and see how we can assist you in navigating the medical device regulatory landscape.
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Industry
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Medical Equipment Manufacturing
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Company size
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51-200 employees
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Headquarters
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Singapore
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Type
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Privately Held
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Founded
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2013
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Specialties
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Regulatory Affairs, Product Registration & Licensing, Clinical Affairs, Auditing, Authorized Representation, Training & Support, Business Services, Quality Management, Medical Regulatory Compliance, Regulatory Intelligence, medtech, Healthcare, Medical device, In-country Representation, Medical equipment, IVD, and Market access
