Regulatory Compliance Information
ClaroNav is proud to report that it has achieved and maintains compliance with regulatory requirements throughout the world. Our products are designed and manufactured under our ISO 13485:2016 and FDA-compliant Quality Management System and our products are certified to all applicable standards. Please see the list below for our international registrations.
QUALITY MANAGEMENT SYSTEM
ISO 13485 quality system certification (PDF format)
ISO 13485:2016 MDSAP Certificate (ClaroNav) EN ISO 13485:2016 Certificate (ClaroNav) ISO 13485:2016 MDSAP Certificate (ClaroNav Kolahi Inc.)
US FDA Good Manufacturing Practice (GMP)
We are fully compliant with 21 CFR Part 820, US FDA Quality Systems Regulations. View our Establishment Registration on the FDA website
PRODUCT CERTIFICATIONS AND APPROVALS
AUSTRALIA – Devices listed in ARTG
CANADA – Medical Device Licenses
Navident | Navient ENT | Navient Cranial
CHINA – NMPA
ECUADOR
EUROPE – CE Marking certificates (PDF format)
EUROPE – Declarations of Conformity (PDF format)
Navident | MicronTracker | Navient
IRAQ
MEXICO
KOREA – MFDS
SIR LANKA
SYRIA
TAIWAN – FDA
THAILAND
UNITED ARAB EMIRATES – MOH classification certificate
UNITED STATES – FDA 510(k) cleared devices
GLOBAL REGULATORY REPRESENTATIVES
Shown below are in-country regulatory representatives for issues and incident reporting.
AUSTRALIA – Sponsor Representative
Emergo Australia, Sydney, Australia
Telephone: +61.2.9006.1662
EUROPE – Authorized Representative
Emergo Europe, The Hague, Netherlands
Telephone: +31.70.345.8570