South Africa medical device regulations
Official sources linkedSAHPRA rules and guidance for medical device market access, registration, and lifecycle compliance. Each code opens a metadata page with the official source and readable HTML when available.
| Code | Regulation | Category | Effective | Provenance |
|---|---|---|---|---|
| SAHPGL-MD-22 Version 1 | 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. | Registration | February 25, 2026 | Official |
| SAHPGL-MD-04 Version 5 | 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. | Classification | February 28, 2025 | Official |
| Government Gazette No. 40480 / Regulation 1515 | 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. | General | — | Official |
Exports carry source + retrieval dateWhat these codes are
Each row above represents one regulatory instrument. Its code is the authority’s identifier. A regulation page collects the metadata and official source; when readable HTML is available, article links can open and highlight the exact cited passage.
Continue from regulations into practical research
Keep South Africa as the target market while you move into registration records, classification, cross-country product research, or pathway planning.
Classify a device for South Africa
Check a preliminary SAHPRA risk class.
Search registered products
Inspect public SAHPRA records.
Compare products across markets
Search the same product in multiple country registries.
Build a registration plan
Estimate pathway, government fees, preparation, and review time.
Build a reusable product master
Structure company, product, model, approval, and evidence facts once.
Map dossier reuse and deltas
Compare existing evidence against South Africa needs.
Build a market-launch workpaper
Connect route, evidence, labels, representatives, and launch dependencies.
Assess a regulatory change
Test a current SAHPRA update against one product and its evidence.