MEDICAL DEVICE & IVD 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 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