Asia-Pacific Markets

Complete NMPA regulatory compliance solutions for medical devices in China.

• NMPA Product Registration
• Type Testing Requirements
• Clinical Trial Applications
• Local Agent Services

Comprehensive PMDA regulatory pathways for Japanese market authorization.

• PMDA Registration
• Shonin Approval
• Marketing Authorization Holder
• Post-market Safety

End-to-end TGA regulatory services for Australian market entry and compliance.

• TGA Registration
• ARTG Inclusion
• Sponsor Services
• Quality Management

Complete regulatory services for medical device registration in South Korea.

• MFDS Registration
• Product Approval
• Korean Good Manufacturing Practice
• Post-market Surveillance

Complete medical device registration services for Indian market.

• CDSCO Registration
• Import License
• Manufacturing License
• Clinical Trial Approval

Regulatory compliance services for medical devices in Taiwan.

• TFDA Registration
• Medical Device Permit
• Quality System Documentation
• Local Representative

Complete regulatory pathway for medical devices in New Zealand.

• Medsafe Registration
• WAND Database
• Sponsor Requirements
• Quality Assurance

Regulatory services for medical device market entry in Hong Kong.

• MDD Registration
• Listing Application
• Import Licensing
• Compliance Monitoring

Medical device registration and import regulation in macau.

• Medical Device Import Permit
• Product Registration
• Market Surveillance
• Quality Control

Medical device registration and regulatory compliance in Pakistan.

• Medical Device Registration
• Import License
• Quality Assurance
• Market Authorization

Regulatory services for medical devices in Bangladesh.

• Product Registration
• Import Certification
• Quality Standards
• Market Compliance

Medical device regulation and market approval in Sri Lanka.

• Device Registration
• Import License
• Quality Assessment
• Regulatory Compliance