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Regulatory support

Registration is part of the order.

A private-label lens only becomes a product once it is registered in your market. We have taken our lenses through that process in several countries, and we issue the dossier your authority asks for rather than leaving it to you.

Ask about your market →
Track record

Markets we have registered in

Product approvals already obtained outside Korea. If your market is not listed, the same dossier is the starting point.

TH
Thailand
Product approval obtained
UZ
Uzbekistan
Product approval obtained
ID
Indonesia
Product approval obtained
IR
Iran
Product approval obtained

Home market: Korea MFDS manufacturing licence, KGMP certified (KCL-AAB-3191).

Dossier

Documents we issue

Most authorities ask for a subset of the following. Legalisation or apostille is arranged where a market requires it.

Company & system

  • Certificate of Free Sale (CFS)
  • ISO 13485 certificate
  • KGMP certificate
  • CE certificate and Declaration of Conformity
  • MFDS manufacturing licence
  • Business registration and plant details

Product & process

  • Product specification sheet per SKU
  • Manufacturing process flow chart
  • Material composition and MSDS
  • Certificate of Analysis, issued per lot
  • Biocompatibility and cytotoxicity test reports
  • Sterilization validation and shelf-life data
  • Labelling and packaging artwork files
How it works

From market to approval

1Tell us the destinationWe confirm which documents your authority requires and in what form.
2Dossier issuedWe prepare and sign the document set, legalised or apostilled where needed.
3Samples for testingTest articles supplied when local laboratory testing is part of the filing.
4Queries answeredTechnical questions from the reviewer come back to our QA team, not to you alone.
5MaintainedRenewals, change notifications and added SKUs handled on the same file.
Labelling

Labelled for the market it ships to.

Contact lenses are a regulated medical device almost everywhere. The pack has to carry the right marks in the right language before it clears customs, so we build that into the artwork rather than correcting it later.

  • Mandatory marks such as lot, expiry, sterilisation and manufacturer identity
  • Lens parameters printed per blister: power, base curve, diameter
  • Local language inserts and carton text for the destination market
  • Your brand carried across carton, blister and insert
Carton panel carrying manufacturer, model name, packaging unit, refractive power, lot and date, diameter, base curve, contents and period of use
A production carton panel. Manufacturer, model, packaging unit, power, diameter, base curve, water content and period of use all sit on the pack before it ships.

Which market are you filing in?

Tell us the country and the product, and we will come back with the document list your authority expects.

Start the conversation →See quality basis