Certifications
Certified quality, regulator-ready documentation
Every shipment is backed by the certificates your regulator and tender committee ask for.
ISO 13485:2016
Certified QMS
CE Marked
EU MDR compliant lines
90+ Countries
Active export markets
FOB · CIF · DDP
Sea & air freight
Quality certifications
- ISO 13485:2016
- CE Marked Products
- ISO 9001:2015
- WHO-GMP Partner Plants
- US FDA Registered Products
Documents we provide
- Certificate of Free Sale (CFS)
- ISO 13485 & CE certificates
- Declaration of Conformity
- Technical files & IFUs
- Batch test reports & sterilisation validation
- Certificate of Origin & legalisation
Regulators we support
We prepare submissions for SFDA, MOHAP, NAFDAC, PPB, SAHPRA, EDA, DGDA, TGA, Health Canada, US FDA, ANVISA, COFEPRIS and many more.