global registration

Is your medical device doing well in the UK and you want to take the next step?

Would you like to expand into Europe, the US or other international markets but are unsure how?

Do you just want to know more about the time and cost of entering new jurisdictions?

At IMed we have the expertise to advise you on precisely what’s needed to take your device onto the World stage.
Of course, the World markets are diverse and so too are the Medical Device regulations in each territory. Regulatory compliance operates on similar core principles worldwide, but because regulations are incorporated into statutory law in each country, it is a legal requirement that they are adhered to exactly. So, it’s important that even minor differences are understood and addressed when seeking approval for your device in a new country.

IMed’s team can easily analyse the variations between markets and modify your regulatory plan and documentation to satisfy the regulatory authorities wherever you need them. If there’s anything you need to update or adapt, we’ll be able to tell you what it is and help you verify and record critical steps for inclusion.

Your IMed expert will protect your growing business by defining its specific regulatory strategy ‘per market’, then:

•  Compile and review device technical documentation
•  Complete the regulatory submission process on your behalf
•  Help manage any post-market responsibilities

For any manufacturer, overcoming these regulatory hurdles is essential to gain access new markets and business growth, so why not leave it to us and get it right first time?

IMed have a wealth of experience in dealing with Medical Device Regulations, including the following markets:

Market Medical Device Regulation
United KingdomMHRA - UK MDR 2002
European UnionIVD (98/79/EC, 2017/746) Medical Device (2017/745)
United StatesFDA - 510(k), PMA
CanadaHealth Canada (MDL, MDEL)
AustraliaTGA - TG(MDR)2002
Saudi ArabiaSFDA - Decree No. 1-8-1429/2008
JapanPMDA - PMD Act
BrazilRDC ANVISA 16/2013
Other Global Markets Available On Request

For any manufacturer, overcoming these regulatory hurdles is essential to gain access to new markets and business growth, so why not leave it us and get it right first time? Call us on 01295 724286 or email us at hello@imedconsultancy.com.

Do you need help with a Medical Device or IVD project?

Need help with implementing or maintaining a Quality Management System?

See how we can work with you to help achieve your business goals.