a) manufacturers of medical devices in South Africa and the The European Union's CE certificate, to show conformity to all obligations for medical
Licence_Medical_Devices_IVDs_Nov19_v3.pdf
31 mar 2015 · Medical laboratories; • Certification Bodies; • Inspection Bodies; • B-BBEE Rating agencies; and •Monitoring of GLP compliance with
Ledimo--Accreditation-of-conformity-assessment-services-for-medical-devices-in-South-Africa.pdf
Regulation and control of medicines and medical devices is not an ISO 13485 (2016) Accreditation of South African Conformity Assessment Bodies
jane-rogers.pdf
2 10 Processes to Supply Medical Devices or IVDs in South Africa 9 11 Options for conformity assessment certification for medical devices containing
8.01-general-guideline-device-ivd-aug14-v1.pdf
Conformity assessment is primarily the responsibility of the medical device manufacturer However, for devices sold in South Africa - it is undertaken in
8.03-Conformity-Assessment-for-Medical-Devices-for-comment.pdf
co za/medicines-and-related-substances-control-act-1965/ General Regulations Relating to Medical Devices and In Vitro Diagnostic Medical Devices [hereafter
zaf.pdf
25 nov 2016 · Accreditation of South African Conformity Assessment Bodies (iii) certification to a Quality Management System for medical devices and
Medical-Device-Reg-Framework-Jane-Rogers.pdf
9 fév 2018 · For these devices the route is self-declaration or self- certification as described in Annex VII Module A, EC Declaration of Conformity The
INVE_MEM_2018_298343.pdf
13 déc 2018 · certification, which means that the equipment is certified to meet “SANAS” means the South African National Accreditation System (SANAS)
draft-conformity-assessment-framework-for-equipment-authorization.pdf