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Andaman Medical

Our Services are Your Solutions
Strategic support tailored to your market access needs

QMS Compliance - ISO 13485 Compliance

One-Stop Access into Asia

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Hong Kong

Taiwan

Japan

Our Services - Solutions to Your Regulatory Challenges.

Medical Device Registration

Medical Device 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

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.

Import Solutions

Import Solutions

Let us handle the complexities of international trade regulations in the Philippines, Indonesia, and Thailand. As the license holder, we ensure efficient customs clearance and timely delivery, backed by our extensive knowledge of global trade requirements.

Post-Market Compliance Management

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.
Our Services - Solutions to Your Regulatory Challenges
Learn more about what we can do for you — browse our brochures and leaflets in English, Chinese and Japanese.

Medical Device Registration

Medical Device 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

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.

Import Solutions

Import Solutions

Let us handle the complexities of international trade regulations in the Philippines, Indonesia, and Thailand. As the license holder, we ensure efficient customs clearance and timely delivery, backed by our extensive knowledge of global trade requirements.

Post-Market Compliance Management

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.
Our Services

As the expert in medical devices and IVDs regulatory affairs and market access, we streamline your registration process across Asia markets, ensuring a seamless experience and guide you through Asia’s evolving regulatory landscape, safeguarding your product’s compliance and bring your products to market efficiently and compliantly.

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