Sliders – Team – Country

As Cambodia’s regulatory landscape evolves, our Cambodia team provides strategic insights and proactive guidance for market entry and compliance. Fluent in Khmer, with a deep understanding of the local market, they help ensure your business thrives in this emerging region.

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.

Our Philippines team specialises in navigating local regulatory frameworks, providing expertise in product licensing, adverse event reporting, and post-market surveillance. Fluent in Filipino and English, their local presence and industry expertise ensure compliance at every stage.

• IVDs regulated by Ministry of Health as medical devices
• 4 risk classes (A-D) aligned with ASEAN MDD
• All IVDs require registration; some additional requirements for HIV and COVID tests
• MoH total review timeline: 45-80 working days based on risk class

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.

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.

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.