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Do you require a medical device establishment license from SAHPRA in order to supply a surgical gloves?

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  • Do you require a medical device establishment license from SAHPRA in order to supply a surgical gloves?

If the gloves are sterile, then your company require a medical device establishment license from SAHPRA. A company that supplies only non-sterile, non-measuring Class A medical devices is exempt from requiring a medical device establishment license from SAHPRA.

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