Southeast Asia Markets

Complete TFDA regulatory compliance solutions for medical devices and healthcare products.

• TFDA Medical Device Registration
• Product Listing and Notification
• Import License Applications
• Post-market Surveillance

Comprehensive HSA regulatory pathways for medical device market authorization.

• HSA Product Registration
• Risk Classification Assessment
• Quality Management System Review
• ASEAN Harmonization Support

End-to-end MOH regulatory services for Vietnamese market entry and compliance.

• MOH Medical Device Registration
• Free Sale Certificate Preparation
• Local Testing Requirements
• Import-Export Procedures

Complete regulatory services for medical device registration in Philippines.

• PFDA Product Notification/Registration
• License to Operate Applications
• Certificate of Product Registration
• Market Surveillance Compliance

Regulatory pathway for medical devices entering the Malaysian market.

• MDA Medical Device Registration
• Establishment License Applications
• Conformity Assessment Body Liaison
• Post-market Vigilance

Complete medical device registration services for Indonesian market.

• BPOM Medical Device Registration
• Distribution License Applications
• Local Clinical Trial Support
• Technical Documentation Review

Regulatory compliance services for medical devices in Myanmar.

• FDAM Product Registration
• Import License Applications
• Product Quality Testing
• Market Authorization Support

Complete regulatory pathway for medical devices in Cambodia.

• CAMFDA Registration
• Product Import Permits
• Quality System Documentation
• Market Compliance Monitoring

Regulatory services for medical device market entry in Laos.

• FDD Product Registration
• Import License Applications
• Customs Clearance Support
• Distribution Channel Setup