🇿🇦South Africa Medical Device Regulations

Medical Device Regulatory Reliance Guideline

Defines reliance pathways SAHPRA may use for device and IVD registration, establishment licensing, clinical trials, ISO 13485 audits, and post-market activities.

Classification of Medical Devices and IVDs

Current SAHPRA guideline for applying Classes A–D to medical devices and IVDs for establishment licensing and product-registration purposes.

Regulations Relating to Medical Devices and IVDs

Core South African regulation for medical devices and IVDs under the Medicines and Related Substances Act, including establishment licensing, registration, labeling, and vigilance obligations.