ISO 13485 certification is a prerequisite for the application or renewal

The South African Health Products Regulatory Authority (SAHPRA) has indicated that ISO 13485 certification is a prerequisite for the application or renewal of a medical device license, with effect from 1 April 2025, which effectively means that companies applying for licenses from 1 January 2025 would need to be certified (considering the 90-day period before license expiry).