Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Ukraine Medical Device Industry Gets Hoped-For Transition

This article was originally published in SRA

Executive Summary

The deadline by which medical devices can be imported and introduced into circulation in Ukraine using existing, state registration certificates has been extended by a year, until July 1, 2017.

You may also be interested in...



Ukraine Medtech At Last Crosses From State To DoC Regulatory System

Ukraine's EU-aligned medtech regulatory system, using notified bodies and manufacturers' Declarations of Conformity (DoC), came into effect on July 1. The state retains a role in surveillance, but it no longer controls medtech registration; companies must now comply with three technical regulations (akin to the EU medical device directives) to access the medtech market in Ukraine.

Time Running Out For Compliance With Ukraine Device Law

The weeks are ticking down until the launch of Ukraine's Declaration of Conformity (DoC)-based system of medical device regulation on July 1. Old certificates will be invalid after that date, and companies should not be banking on further delays to a system that has already been subject to deadline extensions.

‘Ready For Day 1’ – UK MHRA’s Statement Of Intent For Post-Brexit Medtech Regulatory System

The MHRA has been working all hours to ensure the standalone medtech UKCA mark works operationally and procedurally in the UK as of 1 January 2021.

UsernamePublicRestriction

Register

LL026487

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel