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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.

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Singapore

Our Singapore team is at the forefront of product registration, post-market surveillance, and navigating customs regulations. With proficiency in English and Mandarin, and expertise in ISO 13485 standards, they provide comprehensive support to help clients succeed in a fast-changing regulatory landscape.

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Vietnam

Our Vietnam team brings extensive expertise in the medical device sector, offering key insights into regulatory changes, product registration, and compliance monitoring. Fluent in Vietnamese, they ensure your business stays competitive and fully compliant in this fast-evolving market.

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Malaysia

Our Malaysia team consists of regulatory and distribution experts, offering compliance solutions in both Bahasa Malaysia and English. With a proven history of successful product registrations and market launches, they bring deep insights into the local healthcare ecosystem. From consultation to approval, they provide comprehensive support through every stage of the regulatory process.

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Indonesia

Specialising in product registration, post-market surveillance, and local compliance in Bahasa Indonesia, our local team is able to offer seamless market access minus the fuss. Our team has years of experience and deep understanding of Indonesia’s unique regulatory environment, which helps expedite the approval process and ensure that all regulatory requirements are met accurately and efficiently.

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Reporting

  • The Department of Medical Equipment and Construction (DMEC) conducts post-market inspections to ensure the quality of imported and circulated devices.
  • PMS activities include inspections, sampling, testing, and adverse event reporting.
  • Manufacturers and distributors must report any adverse events or product defects to the authorities.

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