Who We Are
UC MedAccess is the regulatory and market access services arm of Unison Collaborative Pte. Ltd., an established medical device business operating under the UC Biosciences brand across Southeast Asia.
We support medical device and in vitro diagnostic (IVD) manufacturers seeking to navigate regulatory requirements and access markets in Singapore, Malaysia and the Philippines.
Our regulatory teams support manufacturers throughout the product lifecycle, from initial regulatory assessment and market-entry planning through product registration, regulatory submissions, registration maintenance and post-market support.
Local Knowledge. Regional Perspective.
Our Regulatory Capabilities
UC MedAccess supports medical device and IVD manufacturers across the regulatory lifecycle, including:
Regulatory strategy and market-entry assessment
Medical device classification
Medical device and IVD registration support
Technical and regulatory documentation review
Regulatory submission support
Management of regulatory queries
Registration maintenance and change notifications
Post-market regulatory support
Regional regulatory coordination
Part of an Established Medical Device Business
UC MedAccess is part of Unison Collaborative Pte. Ltd., which operates its medical device business under the UC Biosciences brand.
This connection gives UC MedAccess practical insight into the commercial and operational requirements involved in bringing medical technologies into Southeast Asian markets, complementing our regulatory capabilities with an understanding of market access and medical device distribution.