Regulatory Compliance Information

QUALITY MANAGEMENT SYSTEM

ISO 13485 quality system certification (PDF format)
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

ARGENTINA  │ Navient

AUSTRALIA – Devices listed in ARTG  │ Navient

CANADA – Medical Device Licenses | Navient │ Navient ENT │ Navient Air

CANADA – Establishment Licence | Navient

CHINA │ Navient (NE Model and NC Model) ENT

COLOMBIA │ Navient

ECUADOR │ Navient

EUROPE – CE Marking certificates  │ Navient │ Navient - MDR │ Navient Instruments - MDR

EUROPE – Declarations of Conformity │ Navient │ Navient Air │ Navient Disposable Instruments │ Navient Instruments │ Navient - MDR

GUATEMALA │ Navient

HONDURAS │ Navient

INDONESIA │ Navient

IRAQ │ Navient

JAPAN │ Navient

MACEDONIA │ Navient

MEXICO │ Navient

MOROCCO │ Navient

PERU │ Navient

PHILIPPINES | Navient │ Navient ENT 

SAUDI ARABIA | Navient 

TAIWAN – FDA | Navient and Navient Air │ Navient ENT

UAE │ Navient NE Model │ Navient NC Model │ Navient Air

UNITED STATES – FDA 510(k) cleared devices  │ Navient NE Model │ Navient NC Model ( ENT - Cranial )

URUGUAY | Navient NC Model

VIETNAM │ Navient

GLOBAL REGULATORY REPRESENTATIVES

Shown below are in-country regulatory representatives for issues and incident reporting. 

AUSTRALIA – Sponsor Representative
Evolution Surgical Pty Ltd
Telephone: +02.9428.1084

BRAZIL – Authorized Representative
Celereach Importação e Distribuição de Produtos Médicos LTDA

Rua Francisco Sales nº 119 sala 704, Pará de Minas, MG, Brasil

CEP: 35.660-017

EUROPE – Authorized Representative
Emergo Europe

Westervoortsedijk 60, 6827 AT Arnhem, The Netherlands
Telephone: +31.70.345.8570

JAPAN – Authorized Representative
SURGICAL SPINE INC.

2-19-1 Ichigaya-Tamachi, Shinjuku-ku, Tokyo 162-0843 Japan