Medical Equipment Licenses & Regulatory Requirements
Important Notice: This information is for guidance only. Regulatory requirements may change, and it is your responsibility to verify compliance with current South African laws. M-Squared Medical is not liable for regulatory advice.
As a leading supplier of medical equipment in South Africa, M-Squared Medical is committed to ensuring all products meet regulatory standards. Below is an overview of key licenses and requirements for purchasing, importing, and operating medical equipment in South Africa.
1. South African Health Products Regulatory Authority (SAHPRA)
All medical devices must be registered with SAHPRA before they can be imported, sold, or used in South Africa. SAHPRA classification depends on the device's risk level:
- Class A (Low Risk): General controls, no pre-market approval needed but must be listed.
- Class B (Low-Moderate Risk): Requires SAHPRA evaluation and registration.
- Class C (Moderate-High Risk): Full clinical evaluation and registration required.
- Class D (High Risk): Rigorous clinical trials and SAHPRA approval mandatory.
Requirements: Importer must hold a SAHPRA license. Registration valid for 5 years.
2. Import Permits and Customs
Medical equipment imports require:
- Import permit from the International Trade Administration Commission (ITAC).
- SAHPRA import authorization for controlled devices.
- Customs declaration (SAD 500 form) and proof of SAHPRA registration.
- Compliance with South African Revenue Service (SARS) tariff codes for medical devices.
Duties: 0-20% depending on device classification. VAT at 15% applies.
3. Healthcare Facility Licenses
If purchasing for a facility, you may need:
- Private Healthcare Facility License: From Provincial Department of Health.
- Radiation Control License: For X-ray or radiation-emitting devices, from Department of Health.
- Pharmacy License: If equipment involves pharmaceuticals or contrast agents.
4. Professional Registrations
Healthcare professionals using the equipment must be registered with:
- Health Professions Council of South Africa (HPCSA) for doctors, nurses, etc.
- South African Nursing Council (SANC) for nursing professionals.
- Professional Board for Radiography and Clinical Technology for imaging specialists.
5. ISO and Quality Standards
All medical devices supplied by M-Squared Medical comply with:
- ISO 13485: Quality management systems for medical devices.
- ISO 14971: Risk management for medical devices.
- CE Marking (for EU compliance) or FDA clearance where applicable.
We provide certificates of conformity with all equipment.
6. Service and Maintenance Requirements
Post-purchase, you must ensure:
- Annual servicing by SAHPRA-accredited technicians.
- Record-keeping of maintenance logs for audits.
- Calibration certificates for diagnostic equipment.
7. Key Regulatory Contacts
How We Can Help
At M-Squared Medical, we assist with regulatory compliance by providing:
- Pre-purchase regulatory guidance.
- Documentation support for SAHPRA registration.
- Import facilitation services.
- Training on equipment compliance and maintenance.
Note: This is general information. Consult legal/regulatory experts for specific advice.
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