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 21 CFR parts: 820, 809, 822 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