Japan, Ministry of Health, Labour and Welfare:
Points to Consider for Reprocessed Single-Use Medical Devices (Provisional Translation, December 2018) “…The [...]
-
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, specification development, production, [...]
World Health Organization:
WHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical [...]
Association for the Advancement of Medical Instrumentation:
AAMI TIR 30: A Compendium of Processes, Materials, Test Methods, and Acceptance Criteria [...]
Canada, Canadian Agency for Drugs and Technologies in Health:
Reprocessing of Single-Use Medical Devices: A 2015 Update “…Given that there are no [...]
Australia, Therapeutic Goods Administration:
Regulatory Guidelines for Medical Devices (2011), Section 19 Single-Use Devices (SUDs) and the [...]