South Africa represents a key emerging market in Africa for pharmaceuticals, medical devices, and cosmetics, with growing healthcare needs and increasing demand for high-quality, innovative products.
The South African Health Products Regulatory Authority (SAHPRA), which replaced the Medicines Control Council (MCC), is the national regulatory body responsible for the registration, licensing, and oversight of medicines, biologics, medical devices, in vitro diagnostics, complementary medicines, cosmetics, and related products. SAHPRA enforces stringent standards aligned with international best practices (including ICH, IMDRF, and WHO guidelines). The transition to SAHPRA and ongoing regulatory developments can introduce procedural complexities for foreign manufacturers seeking registrations, approvals, and market access. MedWisdom LifeScience provides comprehensive regulatory support, offering strategic advice, up-to-date regulatory intelligence, dossier preparation, local compliance guidance, and hands-on assistance throughout the full regulatory lifecycle to help global manufacturers navigate these challenges and achieve successful, sustained entry into the South African market.
Get South Africa Compliance Support
End-to-end support for SAHPRA marketing authorization applications for medicines, generics, biologics, and complementary products.
Guidance through SAHPRA medical device licensing (Class A–D), conformity assessment, and registration aligned with South African regulations.
Preparation and submission of cosmetic notifications/registrations to SAHPRA, including ingredient compliance and safety assessments.
Compilation and submission of Clinical Trial Applications to SAHPRA and ethics committees, including protocol support and regulatory follow-up.
Support for clinical evaluation reports, performance studies, and post-market clinical follow-up for medical devices per SAHPRA requirements.
Preparation of safety and efficacy data packages, gap analyses, and supporting documentation for SAHPRA registration dossiers.
Management of variations, amendments, renewals, and post-approval changes to SAHPRA-registered products.
Preparation for SAHPRA inspections, internal QMS audits, and implementation of corrective actions aligned with South African standards.
Review and optimization of labelling, patient information leaflets, and packaging to meet SAHPRA multilingual and regulatory requirements.
Local pharmacovigilance system setup, adverse event reporting to SAHPRA, PSUR submissions, and risk management plan support.
Risk management file development (ISO 14971), ISO 13485 QMS implementation, and SAHPRA-aligned risk assessments for devices.
Review of promotional materials, claims, and advertising to ensure compliance with SAHPRA and South African advertising regulations.
Guidance on SAHPRA GMP requirements, site readiness, documentation preparation, and support for GMP certification/inspections.
Compilation and submission of complete technical dossiers for medical devices to SAHPRA, including STED-aligned formats.
Support for SAHPRA import/export permits, Section 21 authorizations, batch release, and customs compliance for regulated products.
Assistance with pharmacy establishment licensing, wholesaler/distributor permits, and related SAHPRA requirements.
English labelling/IFU review, artwork preparation, and compliance with SAHPRA-specific requirements for devices and cosmetics.
Ingredient screening, compliance checks against SAHPRA prohibited/restricted lists, and safety substantiation for cosmetics and complementary products.
Partner with Medwisdom for expert, reliable, and fully compliant regulatory support in South Africa — from SAHPRA registrations and clinical trial applications to pharmacovigilance, GMP compliance, and long-term market success.
Contact Our South Africa Regulatory Experts