Global Regulatory Resources
Latvia: Changes in the legal landscape for medical devices in the Baltics – MDR/IVDR
As well as this, the draft regulations introduce the recycling [...]
Legal Framework: Belgium
Belgium published guidelines for the remanufacturing of single use medical [...]
Legal Framework: Netherlands
The Netherlands published guidelines for the remanufacturing of single use [...]
Legal Framework: Germany
The legal basis for reprocessing under German law (MP Betreiber V) changes on [...]
AMDR Reaction to Swedish Socialstyrelsen Report: Prerequisites for Reprocessing and Reusing Disposable medical Devices in Sweden
The Association of Medical Device Reprocessors (AMDR) applauds the Swedish [...]
United Nations Development Programme: Sustainable Health Procurement Guidance Note
To have an impact on planetary health requires bold vision, [...]
Japan, Ministry of Health, Labour and Welfare:
Points to Consider for the Preparation of Applications for Marketing [...]
Japan, Ministry of Health, Labour and Welfare:
Points to Consider for Reprocessed Single-Use Medical Devices (Provisional Translation, [...]
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South Africa, Department of Health, Medicines and Related Substances Act, Regulations Relating to Medical Devices and In Vitro Medical Devices (9 December 2016) GallerySouth Africa, Department of Health, Medicines and Related Substances Act, Regulations Relating to Medical Devices and In Vitro Medical Devices (9 December 2016)
South Africa, Department of Health, Medicines and Related Substances Act, Regulations Relating to Medical Devices and In Vitro Medical Devices (9 December 2016)
“…’manufacture’ means operations that include the design, purchasing of material, [...]
World Health Organization:
WHO Global Model Regulatory Framework for Medical Devices Including in [...]
Association for the Advancement of Medical Instrumentation:
AAMI TIR 30: A Compendium of Processes, Materials, Test Methods, [...]
Canada, Canadian Agency for Drugs and Technologies in Health:
Reprocessing of Single-Use Medical Devices: A 2015 Update “…Given that [...]