Regulatory Services - Andaman Medical

Andaman Medical has been turning regulatory challenges into market opportunities throughout Southeast Asia since 2013. Our comprehensive solutions ensure smooth market access for medical device and IVD companies globally.

With eight strategic offices across Southeast Asia and additional coverage in East Asia through Nord Pacific Medical, we provide comprehensive regional support for Medical Device & IVDs Registration, Authorised Representative Services, Import Solutions and Post-Market Compliance Management.

Our Services

Tailored Strategies for Regulatory Success

Medical Device & IVD Registration

Medical Device & IVD Registration

Our seasoned in-house team streamlines complex regulatory requirements, offering a one-stop solution for document preparation, submission, follow-up, and approval. This significantly reduces approval timelines while ensuring full compliance and minimizing risks.

Authorized Representative Services

As your dedicated authorized representative, we serve as your trusted liaison with regulatory authorities. Our proactive approach and deep regulatory expertise ensure your interests are protected throughout the process. As an independent license holder, we provide flexibility to work with different distributors, ensuring seamless transitions and full control over your licenses.

Medical Device Compliance Consultancy

Expert guidance across Southeast Asia. With deep knowledge of local regulations and global standards, Andaman Medical streamlines your product’s path from development to distribution, minimising risks and accelerating market entry.

Post-Market Compliance Management

We assist with post-market incident reporting, including Field Safety Corrective Actions (FSCAs), mandatory problem reporting, and recalls. We monitor regulatory changes, manage reporting obligations, and implement updates, allowing you to focus on growing your business while maintaining full compliance.

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Our Services

Medical Device & IVD Registration

Medical Device & IVD Registration

Authorized Representative Services

Authorized Representative Services

Medical Device Compliance Consultancy

Medical Device Compliance Consultancy

Post-Market Compliance Management

Post-Market Compliance Management

Stay Ahead in Southeast Asia’s Medical Device Market!

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Stay Ahead in Southeast Asia's Medical Device Market!