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 Philippines FDA requirements — with precision, speed, and regional expertise.

Explore Services

Regional Expertise

Deep understanding of
Southeast Asia regulations.

Product Registration

Guiding Manufacturers from planning to approval.

End-to-End Support

Supporting your products throughout their lifecycle

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

Malaysia

Medical Device Authority

Regulatory Consulting, Licensed Importer Services, Registration Support

Philippines

FDA Philippines

Regulatory Consulting, Licensed Importer Services, Registration Support

How We Work

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