Medical Device Services

Regulatory Affairs

Finding your way through the regulatory landscape can be difficult, because it requires up-to-date knowledge, experience and contacts. Our regulatory team guides you along the most efficient and optimal strategic path to CE-mark, device registration and approval outside EU and support in building up and use post market surveillance.

Regulatory Affairs Services- Medical Devices, IVDS & OTC Drugs

The areas in which we can make a difference include:

  • Classification of the devices and regulatory strategy with reference to the intended use
  • Perform the toxicological evaluations
  • Establishment and maintenance of technical files for medical devices, in vitro diagnostic devices and over the counter drugs
  • This include performing the biological evaluations, clinical evaluations and preparing post-marketing, surveillance plans, post-marketing follow-up studies, risk management files, usability engineering file, conformity assessment to standards, CE labelling according to MDD/IVD – MDR/IVDR, essential requirements check lists, shelf life file and assessment of the regulatory impact on design changes
  • Prepare and submit applications with FDA and maintain FDA submissions
  • Implementation of the FDA’s UDI requirements on medical devices.

Compliance

We provide regulatory support to comply with the below directives and regulations: 

EU: Directive 93/42/EC and MDR 2017/745 on medical devices 

EU: Directive 98/79/EC and IVDR 2017/746 on in vitro diagnostic medical devices

USA: FDA CFR 21, part 820 and part 349 over the counter drugs

Canada: Canadian Medical Devices Regulation SOR 98-282 and NNHPR, SOR/2003-196 (Natural Health Products)

Australia: TGA ARGMD (Medical Devices)

Singapore: HSA GN-01 (Medical Devices)

Brazil: INMETRO and ANVISA's regulatory requirements

Further information regarding services, expertise and how our experience can support your business; please contact us at +4526709648, Email: info@toxregulatoryaffairs.com