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, fabrication, assembly, processing, reprocessing, releasing, packaging, repackaging, labelling, and refurbishing of a medical device or IVD, as the case may be, and
Good As New – Reprocessing Single-Use Devices
Source: Medical Device Developments There are many challenges to pre-hospital sterilisation methods of medical equipment, from single-use disposable devices to longer-lasting equipment designed to work for years. Kerry Taylor-Smith explores the ongoing debate around reprocessing single-use
Reprocessed Medical Devices Market Expected to Surpass $5 Billion by 2023
A new report by Global Market Insights forecasts that revenue from the reprocessed medical device market will increase by 20% CAGR by 2023, growing from $1.12 billion to over $5 billion. "Based on the type of product,
AMDR Presents at CleanMed Europe 2016
CleanMed Europe 2016 – Day 3 Round-Up The final day of CleanMed Europe 2016 featured a wide range of parallel sessions where participants shared ideas and best practices on a wide range of topics including
World Health Organization:
WHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices “…In adopting a policy on the reprocessing of SUMDs, the regulatory authority should consider the following: reprocessing of a SUMD as
Nelson Labs:
Reprocessing Single-Use Devices (2016) “…There are many items that need to be addressed to successfully reprocess SUDs. The experts at Nelson Laboratories provide the following services to help third-party reprocessors with their process validations:” https://www.nelsonlabs.com/reprocessing-single-use-devices/