With surgical implants, companies are obliged to hold records for the natural life of a patient. This is for tracking, vigilance and recall. How will POPI affect these records? Consider that a healthcare provider who performed the surgery and maintains the record could go out of business 5 years after the surgery and a product recall could take place 10 years after that surgery.
With surgical implants, companies are obliged to hold records for the natural life of a patient. This is for tracking, vigilance and recall. How will POPI affect these records? Consider that a healthcare provider who performed the surgery and maintains the record could go out of business 5 years after the surgery and a product recall could take place 10 years after that surgery.
Medical Device Regulations say the information should be retained for a period of 50 years and there are additional options under POPI
