REDDOT LED ensures global market access for our phototherapy devices through four core certifications: ISO 13485 establishes the foundational quality management system (QMS); MDSAP (Medical Device Single Audit Program) provides a single audit accepted by major markets (USA, Canada, Australia, Japan, Brazil), streamlining global compliance; MDL (Medical Device Licence) is the key to the Canadian market; and TGA (Therapeutic Goods Administration) is Australia's regulator, which accepts MDSAP for market entry. This multi-certified approach guarantees safety, efficacy, and quality for customers worldwide.