Holder of Certificate of Registration (HCR)
Applicants must appoint a local South African legal entity as the HCR to take responsibility for the product.
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, and distributors planning to enter or operate in the South African market
Medical Device Registration
- Establishment Licensing: Currently, all medical device manufacturers and distributors must hold a valid SAHPRA establishment license.
- ISO 13485: Certification is required to demonstrate compliance with quality management systems.
- Registration Phase-in: While licensing is mandatory, full registration of medical devices is being rolled out in a phased approach based on risk classification (Class A-D).
Post-Registration Compliance
Pharmacovigilance: Mandatory reporting of adverse drug reactions (ADRs) and quality issues via the Med Safety App or to SAHPRA.
Variations
Post-approval changes must be submitted via the Variation Addendum process
Key Components of SAHPRA Registration :
Our Consulting Services
Navigating SAHPRA Registration:
Your Gateway to the South African Health Market
Entering the South African pharmaceutical and medical device market requires navigating complex, yet structured, regulatory requirements set by the South African Health Products Regulatory Authority (SAHPRA). As the national regulatory authority, SAHPRA ensures that all health products—medicines, medical devices, and in vitro diagnostics (IVDs)—meet stringent safety, quality, and efficacy standards.
For foreign manufacturers and local distributors, partnering with an experienced regulatory consultancy is the fastest way to bridge compliance gaps and secure market access.
Key Regulatory Areas:
We provide end-to-end consulting for all SAHPRA-regulated products:
Medical Device & IVD Registration
- Establishment Licensing: Assisting manufacturers, importers, and distributors in obtaining mandatory SAHPRA licenses.
- Classification & Compliance: Classifying devices (Class A, B, C, D) and preparing technical documentation.
- ISO 13485 Standards: Ensuring compliance with Quality Management Systems (QMS) required for licensing.
- Authorized Representative (AR): Providing in-country representation services for foreign manufacturers.
Why Choose Our Consultancy ?
- Expertise in Local Legislation: In-depth knowledge of the Medical Devices registration, post marketing processes
- Streamlined Processes: We help reduce the lengthy approval timelines (often ranging from 6 to 24 months) by ensuring compliant, high-quality submissions.
- Focus on Compliance: Ensuring your products meet SAHPRA’s high standards for quality, safety, and efficacy, protecting your brand reputation.
