ISO 13485 Resources
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ISO 13485 requirement extension for Medical Devices Establishment Licences
The South African Health Products Regulatory Authority (SAHPRA) has issued a communication exempting medical device establishment licence holders from ISO 13485 certification for a period of three years. SAMED welcomed the exemption after numerous engagements with SAHPRA (including via industry workshops and the ITG) on the lack of local conformity assessment bodies, international notified body backlogs created by the pandemic and a lack of clarity that ISO13485 would be the specific industry quality management system.
SAMED recognise that ISO 13485 is the most suitable standard for our sector, but were concerned as to the potential risk to the continuum of patient care and the sustainability of medical technology suppliers should it be a requirement on the first renewal of establishment licences, which for some members is imminent. The exemption provides sufficient time for medtech suppliers to plan, budget and implement the standard and we encourage members note waste the opportunity provided.