Any organisation that manufactures, imports, exports, or distributes medical devices or IVDs in South Africa must hold a SAHPRA Medical Device Establishment Licence.
GH Strategies delivers licensing expertise that positions your organisation for compliant and efficient market operations.
What GH Strategies Delivers
Regulatory Strategy Built on Device Classification
We determine your correct SAHPRA risk classification (Class A–D), align activities to the appropriate licence type, and eliminate errors that commonly delay approval.
Medical Device Establishment Licence Submission
Your MD1/MD2 application is structured with regulatory precision, supported by clear evidence of device categories, distribution pathways, and operational controls.
ISO 13485-Aligned QMS for Licence Approval
We strengthen your QMS documentation – from supplier controls to complaint handling – ensuring alignment with ISO 13485 and SAHPRA’s quality expectations.
Facility & Distribution Compliance Intelligence
We assess storage conditions, environmental controls, device traceability, and distribution pathways to ensure your operations meet device-specific regulatory standards.
Regulatory Liaison & Query Communication
GH Strategies manages correspondence with SAHPRA, ensuring your application remains technically sound, complete, and defensible at every step of the review cycle.
Post-Licence Compliance & Lifecycle Support
We help maintain device compliance with vigilance updates, periodic reporting, QMS improvements, and regulatory intelligence that protects your licence long-term.
Planning to manufacture, import, distribute, or export medical devices in South Africa?
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Four Pillars of a SAHPRA-Ready Medical Device Establishment
SAHPRA requires accurate Class A–D classification, validated device descriptions, and correct mapping between declared activities and the MD1/MD2 application type.
Your QMS must demonstrate control over procurement, storage, distribution, installation, servicing, complaint handling, recalls, and device traceability.
Temperature control, segregation, clean storage, calibration, and distribution oversight must reflect the device category and associated risk class.
All specifications, stability data, process validation summaries, risk assessments, and biostudy documentation are reviewed against SAHPRA’s evolving expectations.
Strategic Value of a SAHPRA Medical Device Establishment Licence
A SAHPRA Medical Device Establishment Licence is not just a legal requirement – it is a regulatory credential that enables legal device importation, distribution, and manufacturing; strengthens quality credibility with manufacturers and global partners; supports faster product registration and market access; reduces operational and supply chain risk; demonstrates ISO 13485–aligned maturity; and positions your business for long-term regulatory resilience.
A strong licence signals that your operations are controlled, traceable, and built for compliant device management.
Frequently Asked Questions (FAQs)
Any entity involved in the manufacture, import, export, distribution, warehousing, servicing, installation, or testing of medical devices or IVDs.
Yes. SAHPRA requires all foreign manufacturers to operate through a licensed in-country representative who assumes regulatory responsibility.
Inspections are based on risk class, declared activities, QMS maturity, compliance history, and post-market vigilance signals.
Yes, if they store or handle medical devices, they must demonstrate GWP for devices and environmental control compliance.
Yes, we assist with classification, QMS alignment, MD1/MD2 submissions, compliant distribution controls, and defined quality accountability.
Distributors take responsibility for device movement and traceability; wholesalers supply devices to other licensed entities; third-party logistics providers store/transport devices but must still demonstrate environmental control and device-handling compliance if acting on behalf of a licence holder.
Let’s Build Something That Lasts
Strengthen your approval prospects with a device-specific licensing readiness review.