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Registration Service RF · EAEU Government Decree No. 1416

Post-registration support

Making changes to the dossier, updating documentation.

01 / Description

Making changes to the dossier, updating documentation.

02 / Scope of work

What the service includes

  • 01 Making changes to the registration dossier and registry entry
  • 02 Bringing documentation to current requirements
  • 03 Cancellation of state registration (at the request of the manufacturer)
Cross-references

These services are frequently ordered together with the current one for comprehensive registration support.

УСЛУГА 01 ON REQUEST

Consulting and preliminary examination

Initial audit of documentation, determination of risk class and medical device type code, selection of registration strategy.

RF · EAEU
jurisdiction
open
УСЛУГА 02 ON REQUEST

Development and execution of documentation

Specifications, manuals, risk management file, medical software validation.

RF · EAEU
jurisdiction
open
УСЛУГА 03 ON REQUEST

Organization and support of tests

Selection of laboratories, technical, toxicological, clinical tests.

RF · EAEU
jurisdiction
open
Inquiry form · 24 hours

Enquiry for «Post-registration support»

Specify the device type and current registration stage — we will prepare a cost and timeline estimate under Government Decree No. 1416 within 24 hours.

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