Global Regulatory Resources
Compliance Navigator BSI: Reuse of single-use medical devices in the European Union
Article 17 of the European Medical Devices Regulation 2017/745 (MDR) covers [...]
European Commission, Implementing Regulation, Single-Use Medical Devices – Safety and Performance Requirements for Reprocessing (2019)
“…Regulation (EU) 2017/745 allows reprocessing of single-use devices only where [...]
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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European Union, Medical Device Regulation of 2017, Regulation (EU) 2017/745 of the Euroepan Parliament and of the Council 5 April 2017, Article 17: GalleryEuropean Union, Medical Device Regulation of 2017, Regulation (EU) 2017/745 of the Euroepan Parliament and of the Council 5 April 2017, Article 17:
European Union, Medical Device Regulation of 2017, Regulation (EU) 2017/745 of the Euroepan Parliament and of the Council 5 April 2017, Article 17:
Single-Use Devices and their Reprocessing “…The reprocessing and further use [...]
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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 [...]
United Kingdom, Medicines & Healthcare Products Regulatory Agency:
Single-Use Medical Devices: UK Guidance on Re-Manufacturing (2016) “…Single-use devices [...]
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 [...]
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Germany, Commission on Hospital Hygiene and Infection Prevention at the Robert Koch Institute and the Federal Institute for Drugs and Medical Devices (BfArM), Hygiene Requirements for the Reprocessing of Medical Devices (2012) GalleryGermany, Commission on Hospital Hygiene and Infection Prevention at the Robert Koch Institute and the Federal Institute for Drugs and Medical Devices (BfArM), Hygiene Requirements for the Reprocessing of Medical Devices (2012)