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@slet-dette.toxregulatoryaffairs.com