01

Information needed for a useful quotation

Provide sector, claims, real facilities/addresses, activities, existing numbers and the actual responsible party. For devices add model, classification and marketing-path evidence; for cosmetics add label/ingredients and facility links; for food identify the real registered facility and renewal work.

Compare each existing document with the proposed task. An old registration confirmation may show a submission but not a new device authorization, changed cosmetic formula or another food-facility address. List accepted inputs and gaps before quoting; do not sell one identical registration package to all sectors.

02

Separate preparation from external product work

Show data preparation and coordination separately from any applicable official device user fees, required US agent work and device testing/clinical or product submissions. Food registration/renewal has no FDA fee; a consultancy charge is a different item. Cosmetic and device duties must not inherit another sector’s fee assumptions.

Example: the device model or intended use differs from the supplied marketing evidence. Registration support may proceed only for the actual appropriate role, but it does not close the missing product pathway. Agree who obtains the classification/evidence review and resulting technical work rather than promising market entry from a registration payment.

03

Timing, changes and decision limits

Required device establishments renew annually for the fiscal year between 1 October and 31 December; required food facilities renew in even years, including 2026. Cosmetic facility renewal is tied to its initial date. These are different milestones and are not a single guaranteed market-entry schedule.

QMSR has applied to covered device quality duties since 2 February 2026; an ISO 13485 certificate alone does not complete registration or the product pathway. Separate preparation, technical gaps, official submissions and ongoing updates. The actual manufacturer/importer and any separately established US agent retain their roles; Kayra does not act for FDA or promise a positive decision.

04

Responsibility

Kayra coordinates scope, evidence and preparation. It does not claim official certification or regulatory authority and does not assume importer, US agent or local applicant status without a separately established role. Official decisions and responsible-party duties remain separate; successful market entry and a fixed date are not guaranteed.

Official sources

Reviewed: 3 October 2026. Check the current rules and assessment route for the actual product.