Market
South Africa
3 articles
Regulatory
South Africa SAHPRA Medical Device Establishment Licenses (3,000 Active)
An in-depth analysis of 3,000 active SAHPRA establishment licenses, examining the balance of distributors, wholesalers, manufacturers, and municipal hubs.
16 min read2026-06-22
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Post-Market Surveillance
Adverse-Event Reporting Compared: FDA 21 CFR 803, EU MDR, Brazil, Thailand & SA
Side-by-side legal-text comparison of device adverse-event reporting: FDA 21 CFR 803, EU MDR Art. 87, Brazil RDC 67/2009, Thailand MoPH, SAHPRA — triggers, timelines, who must report.
14 min read2026-06-16
›Regulatory
South Africa SAHPRA Medical Device Registration Guide 2026
Guide to South Africa SAHPRA medical device registration in 2026, covering establishment licensing, Class A-D classification, ISO 13485, reliance pathways, fees, and AR duties.
14 min read2026-04-08
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