In December, 2017, the South African Department of Health issued a long-awaited regulation on medical devices. In it, the reprocessing or repackaging of medical devices is clearly defined as a manufacturing activity, and therefore subject to the Regulation’s requirements. In AMDR’s review, single-use device (SUD) reprocessors, just like other device manufacturers, must comply with the regulation’s requirements including obtaining an establishment license and registration for each of the products marketed in the country. Further, according to the labeling requirements for medical devices in part 22 of the Regulations Relating to Reprocessing, reprocessors must “state the name of the re-processor and identify the medical device as a reprocessed medical device.”
Similar to what has taken place with the regulatory activities in the U.S., Europe and Japan, the South African regulations will now lead hospitals away from inappropriate and un-validated reuse of devices within hospitals to devices reprocessed by regulated, commercial firms.
South African hospitals now have a safe, regulated option in regulated, commercial reprocessing. MediQ Sustainable Healthcare Solutions is, to AMDR’s knowledge, the first compliant reprocessor on the African’ continent! MediQ is a member of the Association for the Advancement of Medical Instrumentation (AAMI).
We at AMDR look forward to watching the development of regulated, commercial reprocessing in South Africa.
The Association of Medical Device Reprocessors and its members advance reprocessing and remanufacturing to promote financially and environmentally sustainable healthcare. AMDR and its members seek to push the medical technology industry toward greater alignment with healthcare providers. We believe we lead the way for the medical technology industry to promote value and see reprocessing and remanufacturing as a defining role in the evolution and utilization of new device technologies.