Regional Coverage

Supporting medical device and IVD manufacturers across Singapore, Malaysia and Philppines

Singapore

Health Sciences Authority (HSA)

Supporting manufacturers with regulatory requirements for medical devices and IVDs in Singapore.

  • Medical Device Registration
  • IVD Registration
  • Local Authorized Representative
  • Registration Maintenance

Malaysia

Medical Device Authority (MDA)

Providing regulatory support for medical device registration and ongoing compliance in Malaysia

  • Medical Device Registration
  • Authorized Representative
  • Registration Maintenance
  • Regulatory Consulting

Philippines

FDA Philippines

Helping Manufacturers navigate regulatory requirements and market entry into the Philippines.

  • Regulatory Consulting
  • Registration Support
  • Licensed Importer Services
  • Post-Market Support

OUR SERVICES

Why Work With One Regional Partner

Regional Expertise

Coordinated regulatory support across Southeast Asia.

Single Point of Contact

One dedicated team managing your regional projects.

End-to-End Support

From Regulatory strategy and registration to post-market compliance.

Faster Market Entry

Streamlined processes and local expertise to help you reach the market sooner.