ABOUT MEDIPASS
Regional regulatory expertise.
Local execution across ASEAN.
MediPass is a Singapore-based regulatory and market-access partner supporting medical device and IVD manufacturers across Southeast Asia. We coordinate registration strategy, local representation and ongoing compliance across Singapore, Malaysia, Thailand, Vietnam and Indonesia.
WHO WE ARE
Built for manufacturers entering Southeast Asia.
ASEAN offers a regional growth opportunity, but market entry requires country-specific regulatory execution. Each market has its own requirements, submission pathways and local responsibilities.
MediPass brings these requirements into one coordinated plan. We support manufacturers across five markets, connecting regional priorities with the local work needed to move registrations forward and maintain compliance.
OUR OPERATING MODEL
One coordinated approach.
Three connected responsibilities.
Regional Planning
Align target markets, regulatory pathways and documentation priorities with your product and commercial plans.
Local Execution
Coordinate country-specific submissions, local representation and authority correspondence in each target market.
Lifecycle Continuity
Maintain continuity beyond initial registration through changes, renewals and ongoing post-market obligations.
REGULATORY EXPERIENCE
Experience across the regulatory lifecycle.
Our experience spans medical devices and IVDs across multiple risk classes, from registration planning and submission preparation to authority correspondence and market entry.
That work continues through product changes, registration renewals and post-market requirements, helping manufacturers manage regulatory responsibilities throughout the product lifecycle.
THE THINKING BEHIND THE WORK
Regulatory judgement grounded in science and commercial reality.
MediPass combines biomedical and laboratory understanding with regulatory affairs, product development and a business perspective.
This foundation helps connect technical evidence with regulatory requirements and practical market-entry decisions. We consider how a product works, how it is supported by evidence and what manufacturers need to achieve in each market.
OUR PRESENCE IN ASEAN
Local capability across five ASEAN markets.
WORK WITH MEDIPASS