Guided intake
Ask one clear question at a time, translate regulatory language, and only show questions that apply to the establishment.
Medical device establishment licensing
Turn a complicated application into a guided process.
A secure workspace that helps South African medical device businesses prepare a complete, evidence-backed SAHPRA licence application pack.
Start an applicationChecking AI connection
Currently supports GLF-MD-06C v5 for importers/distributors. View the current official SAHPRA form ↗
Application workspace
Licence readiness
- 1Business detailsGuided intake
- 2Products and suppliersFile-assisted
- 3QMS evidenceGap checked
- 4Application packExport ready
Evidence before answers
Every populated field should be traceable to a user answer or an uploaded source document.
Product direction
The form is the output. The evidence trail is the product.
The first release focuses on GLF-MD-06C for a South African site importing and distributing non-IVD medical devices. It will turn uploaded records and plain-language answers into a reviewable application workspace—not replace expert regulatory judgment.
Evidence workspace
Collect company, product, supplier, ISO 13485, and QMS files in one structured application workspace.
Submission pack
Map every answer to its source and generate a completed form, supporting documents, and an expert review checklist.