FAQ

Our factory strictly follows global medical device manufacturing standards and holds complete valid export certifications: ISO13485 Medical Device Quality Management System Certification, official Medical Device Production License, Free Sales Certificate and full product safety test reports. All certifications and product specifications meet the ASEAN Common Technical Dossier (CTD) requirements, ensuring full compliance for export to all ASEAN member countries.

We have rich experience in customs clearance rules for major Southeast Asian markets such as Malaysia, Indonesia, Thailand, Vietnam and the Philippines, and provide a complete set of official customs clearance documents: commercial invoice, packing list, bill of lading, FORM E Certificate of Origin for ASEAN tariff preferences, product test reports and certification copies. We assist clients throughout the customs clearance process to avoid cargo detention, delays or compliance risks, ensuring smooth and legal local sales in the ASEAN region.