ASEAN's medical manufacturing credibility
Malaysia produces the majority of the world's examination gloves, and Thailand has a deep medical device and consumables industry serving hospital groups globally. The region's strength is regulated manufacturing: ISO 13485 quality systems, cleanroom production and established export documentation to the US, EU and Japan.
What importers source successfully
Examination and surgical gloves, syringes and needles, wound care products, laboratory consumables, diagnostic components and Class I devices are the high-runner categories. Thailand also supplies OEM components into global device brands — tubing, moulded parts and assemblies.
Regulatory reality check
You are the legal importer: FDA establishment registration and device listing, EU MDR importer obligations and UKCA responsibilities sit with you, not the factory. What the factory must provide is a verifiable ISO 13485 certificate, device-specific test reports, batch traceability and sterilisation validation where applicable. Verify certificates directly with the issuing body — document fraud exists in this category.
How TUSKO de-risks it
We audit quality systems on-site, verify certifications with issuing bodies, and manage batch documentation so every shipment carries the evidence your regulator or notified body expects. Contact us with your product classification and target markets.