Re-sterilisation can be done by companies which are approved by SAHPRA to refurbish (under the Manufacturing licence) and it should be inline with essential principles set out be the OEM. Medical devices marked as single use may not be re-sterilized, re-used or reprocessed.
Does SAHPRA allow re-sterilisation of a medical device?
This Article Also Answers the Following Questions :
- Can sterilization be done by any SA companies?
- Do companies have to be pre-approved by SAHPRA for re-sterilization of a medical device?