Regulatory Clarity for Medical Devices Across Southeast Asia

UC MedAccess delivers end-to-end regulatory consulting for medical device and IVD manufacturers navigating Singapore HSA, Malaysia MDA, and the Philippines FDA requirements — with precision, speed, and regional expertise.

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Regional Expertise

Deep understanding of
Southeast Asia regulations.

Product Registration

Guiding Manufacturers from planning to approval.

End-to-End Support

Supporting your products from registration through post-market compliance

One Regional Partner

Singapore
Malaysia
Philippines

End-to-End Regulatory Services

From regulatory strategy through product registration and ongoing compliance, UC MedAccess supports every stage of your market entry journey.

✓ Regulatory Strategy
✓ Product Registration
✓ Regulatory Representation
✓ Registration Maintenance
✓ Post-Market Compliance

Singapore

Health Sciences Authority

Medical Device Registration, Licensed IVD Registration, Local Authorized Representative

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Malaysia

Medical Device Authority

Regulatory Consulting, Licensed Importer Services, Registration Support

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Philippines

FDA Philippines

Regulatory Consulting, Licensed Importer Services, Registration Support

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How We Work

  1. Consultation
  2. Strategy
  3. Documentation
  4. Submission
  5. Approval
  6. Lifecycle Support