REGULATORY EXPERTISE. LOCAL EXECUTION.
Trusted Regulatory Partner in Southeast Asia
We help overseas medical device and IVD manufacturers plan registration, arrange local representation, and maintain regulatory compliance across ASEAN markets.
Singapore-based coordination · Country-specific execution
OUR REGIONAL PRESENCE
One partner.
Local understanding.
Connected regional planning, with a dedicated regulatory pathway for each market.
MEDICAL DEVICES / IVDs / SELF-TESTING IVDs / SaMD
OUR PRESENCE IN ASEAN
Start with your target market.
Explore country-specific requirements and understand how MediPass can support your registration and ongoing regulatory needs.
One regional strategy. Country-specific registrations.
ASEAN harmonisation does not create a single medical device certificate valid across all member states. We coordinate your approach while addressing each country’s requirements.
HOW WE SUPPORT YOU
From regulatory planning
to ongoing compliance.
Practical support for manufacturers entering a new ASEAN market or maintaining an existing portfolio.
01
Regulatory Strategy
Clarify product classification, filing requirements and registration priorities before committing to a market-entry plan.
02
Medical Device & IVD Registration
Prepare and coordinate country-specific submissions, including supporting documentation and regulatory authority queries.
03
Local Representation
Arrange the applicable local representative, registrant or licence-holding role according to the target country and product.
04
Establishment Licensing
Support relevant company, importer and wholesaler licensing requirements and local distribution compliance.
05
Import & Market Access Coordination
Align regulatory approvals and local requirements with your importation and market-entry arrangements.
06
Post-Market & Maintenance
Maintain regulatory continuity through renewals, change notifications, authority correspondence and applicable vigilance support.
WHY MEDIPASS
Regional perspective.
Practical execution.
For manufacturers managing multiple markets, consistency matters as much as local knowledge. MediPass connects the regional plan with the work required in each country.
One coordinated ASEAN approach
Plan target markets together, identify shared documentation needs and address country-specific requirements early.
Local regulatory understanding
Work with the appropriate processes, terminology and responsible roles in each jurisdiction.
Support beyond initial approval
Keep registration, local representation and post-market responsibilities connected as your portfolio develops.
HOW WE WORK
A clear path from first discussion
to long-term support.
01
Assess
Tell us about your product, existing approvals and target countries. We identify the regulatory questions to resolve.
02
Plan
Agree the registration strategy, local roles, documentation needs and sequence of work.
03
Execute
Coordinate dossier preparation, local requirements, submissions and authority correspondence.
04
Maintain
Support changes, renewals and applicable post-market responsibilities as your business grows.
LET’S DISCUSS YOUR NEXT MARKET
Your product. Your target countries.
A practical way forward.
Share your product type, current approvals and markets of interest. Our team can help identify the next regulatory steps.
MediPass
Regulatory strategy and market access support for medical device and IVD manufacturers in Southeast Asia.
Contact
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