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EPSI GLOBAL PTE. LTD.

Your Gateway to Asia Pacific Medical Device Regulatory Compliance.

1991 - Present (34+ years)
Registration

Headquarters: Singapore

About EPSI GLOBAL PTE. LTD.

We are an Asia Pacific regulatory affairs and quality compliance consulting firm for medical devices and IVDs. Based in Singapore, they specialize in helping international clients navigate the complex market access requirements across the region, offering local representation and strategic compliance solutions.

Why Choose EPSI GLOBAL PTE. LTD.?

Deep expertise and physical presence across the complex ASEAN region

Strong focus on medical device and IVD regulatory affairs

Ability to act as local Authorized Representative in multiple jurisdictions

Comprehensive QMS and regulatory strategy support

Proven track record assisting foreign manufacturers enter APAC markets

Specializations

10+ Services

Global Presence

7 Offices

Languages

6 Languages

Markets

9 Regions

Recent Updates

Malaysia MDA Launches New Online Submission Portal for Product Registration

November 2025

ASEAN Update
Vietnam MoH Issues New Decree on Medical Device Labeling Requirements

October 2025

Regulatory Update