Our Certifications
You can count on Labtician Ophthalmics to keep you informed of the latest advances while providing you access to the best eye care products and solutions available.
ISO 13485 Certificate
This certificate is granted by Intertek to Labtician Ophthalmics on the basis of Labtician Ophthalmics continuing compliance to the ISO 13485:2016 MDSAP Quality Management System standard. This standard applies specifically to medical devices manufactured by Labtician Ophthalmics.
Medical Device Establishment Licence
This licence is issued by Health Canada to Labtician Ophthalmics and is applicable to the manufacturing of Risk Class I devices and the importation and distribution of licensed medical devices manufactured by foreign manufacturers for which Labtician Ophthalmics distributes in Canada.
Drug Establishment Licence
This licence is issued by Health Canada to Labtician Ophthalmics and is applicable to drug products manufactured by foreign manufacturers for which Labtician Ophthalmics imports and distributes in Canada.
Cells, Tissues and Organs Establishment Licence
This licence is issued by Health Canada to Labtician Ophthalmics and is applicable to the importation and distribution of minimally processed tissue products supplied by foreign manufacturers for which Labtician distributes in Canada.
Natural Health Products Site Licence
This licence is issued by Health Canada to Labtician Ophthalmics and is applicable to the importation and distribution of Natural Health Products manufactured by foreign manufacturers for which Labtician Ophthalmics imports and distributes in Canada.
CE Mark (Annex II) Certificate
This certificate is issued by the British Standards Institute to Labtician Ophthalmics and grants market access to EC and EFTA countries, and covers medical devices manufactured by Labtician Ophthalmics that are classified as Risk Class IIa and higher.
CE Mark (Annex V) Certificate
This certificate is issued by the British Standards Institute to Labtician Ophthalmics and grants market access to the EC and EFTA countries, and covers medical devices manufactured by Labtician Ophthalmics that are classified as Risk Class I, Sterile.
FDA Establishment Registration (USA)
Labtician Ophthalmics maintains their annual Establishment Registration with the USA’s Food and Drug Administration, covering products manufactured by Labtician Ophthalmics and sold in the USA.