National Regulatory Authority
Official healthcare product regulator of South Africa
SAHPRA Registration Consultancy Services
Your Gateway to the South African Healthcare Market
Professional Regulatory Support for Medical Devices, IVDs, Pharmaceuticals and Healthcare Products in South Africa.
What is SAHPRA?
The South African Health Products Regulatory Authority (SAHPRA) is the national regulatory body responsible for ensuring the safety, efficacy, and quality of medicines, medical devices, in vitro diagnostics (IVDs), and radiation-emitting devices in South Africa.
Registration with SAHPRA is mandatory for pharmaceutical companies, manufacturers, importers, exporters, and distributors seeking access to the South African healthcare market.
QM Service Global provides complete regulatory consultancy support to help companies achieve efficient market entry and ongoing compliance.
Key Components of SAHPRA Registration
Essential requirements for successful product registration and licensing.
Holder of Certificate Registration (HCR)
• Appointment of South African Legal Entity
• Local Regulatory Responsibility
• Compliance Management
• Regulatory Representation
• Product Registration Ownership
Establishment Licensing
• Manufacturer Licensing
• Importer Licensing
• Exporter Licensing
• Distributor Licensing
• GMP Compliance Support
Technical Documentation
• eCTD Submission Support
• ZA Module 1 Requirements
• Dossier Preparation
• Documentation Review
• Regulatory Compliance Verification
Product Classification
• New Chemical Entity
• Generic Products
• Biological Products
• Medical Devices
• In Vitro Diagnostics (IVDs)
Medical Device & IVD Registration Services
Establishment Licensing
Licensing support for manufacturers, importers, and distributors.
Classification & Compliance
Classification of Class A, B, C & D medical devices and IVDs.
ISO 13485 Support
Quality Management System compliance for regulatory approval.
Our SAHPRA Consultancy Services
Gap Analysis
Identify compliance gaps before submission.
Submission Management
Complete SAHPRA Portal Submission Support.
Query Resolution
Scientific assessment response and clock-stop management.
Post Approval Support
Renewals, variations and retention fee management.
Post-Registration Compliance
Why Choose QM Service Global?
Local Regulatory Expertise
Strong understanding of SAHPRA requirements and procedures.
Faster Approvals
High-quality submissions to minimize regulatory delays.
End-to-End Support
From registration planning to post-market compliance.
Ready to Launch in South Africa?
Let our regulatory specialists guide your organization through the complete SAHPRA registration process and accelerate your entry into the South African healthcare market.