Country Profile
Geographical Location:
South Africa is located at the southern tip of the African continent, bordered by Namibia, Botswana, Zimbabwe, Mozambique, Eswatini (Swaziland), and Lesotho. It has a long coastline along the Atlantic and Indian Oceans.
Language(s):
South Africa has 11 official languages, with English, Zulu, Xhosa, and Afrikaans being the most commonly spoken in business and healthcare settings.
Population Size:
As of 2025, the population is estimated at 61.8 million.
National Flag:
Overview of Medical Devices and IVDs Regulation
National Regulatory Authority
The South African Health Products Regulatory Authority (SAHPRA) is the national regulatory body responsible for the regulation of medical devices, IVDs, medicines, biologicals, and complementary health products. SAHPRA was officially established in 2018, replacing the former Medicines Control Council (MCC) under the Medicines and Related Substances Act, 1965 (Act 101 of 1965) as amended.
Definitions
Medical Device: Any instrument, apparatus, implement, machine, or implant intended for medical use in humans, including diagnosis, prevention, monitoring, treatment, or alleviation of disease.
In Vitro Diagnostic Device (IVD): A reagent, calibrator, instrument, or system used to examine specimens derived from the human body to diagnose disease or health conditions.
Legal Documents and Guidelines
– Medicines and Related Substances Act 101 of 1965 (as amended)
– SAHPRA Medical Devices and IVDs Guidelines
– Establishment Licensing Requirements
– Classification Guidelines (aligned with IMDRF)
Classification System
SAHPRA classifies:
– Medical Devices: Class A (low risk) to Class D (high risk)
For Non-IVDs, Classification is based on factors like invasiveness, intended use, and duration of contact with the body while the extents of impact on individual and public health determines IVDs risk class.
Regulation Approach / Model
SAHPRA currently uses a risk-based, reliance-oriented model:
– Relies on approvals from stringent regulatory authorities (FDA, CE, TGA, PMDA, Health Canada)
– Requires establishment licensing for importers, distributors, and manufacturers
– Plans to roll out full product registration in phases based on device class and public health relevance
Registration Requirements
As of now, the registration of medical devices has not yet fully started. SAHPRA planned to start phase-based rollout of medical devices registration that of course prioritizes high-risk medical devices. Even, of these devices’ categories, only those that are intended for the diagnosis of HIV and TB were subject to a ‘Medical device registration Voluntary Feasibility Study’. For this study, SAHPRA published an expression of interest request where only licensed medical device establishments having the two mentioned products were called up to show/submit their interest to participate in the study. The study started in May 2024 (please click here to access the document). The study was intended to help SAHPRA readjust its processes and requirements to scaleup its registration activities to include all medical devices gradually. All technical dossiers were required to be submitted for this study and 32 products were subjected to this study from the two categories of devices (i.e., HIV and TB tests).
What’s new now?
Medical devices registration is not yet fully enforced. For foreign manufacturers, SAHPRA requires them to have at least one local authorized representative who has valid medical device establishment from SAHPRA. Then, the authority relies on approval evidences from other reference organizations such as- WHO- Prequalification, US FDA, HC, TGA, MHLW/PMDA, EU, ANVISA.
If a product subject to the registration has not been approved by at least one of these organizations, full dossiers are required and may take longer to approve the product.
In general, the following documents are required:
– Local establishment license
– Classification of the device
– Technical documentation
– ISO 13485 certification for manufacturing sites
– Foreign regulatory approval (if available)
Application Submission and Review Process
Application submission is currently voluntary for most products but mandatory for establishment licensing.
A pilot registration feasibility study began in May 2024 for selected high-risk devices and IVDs (e.g., HIV/TB tests).
Full digital submission systems are under development.
Regulatory Service Fees
SAHPRA charges fees for:
– Establishment licensing
– Licence renewal
– Variations
– Inspections
However, for registration of medical devices, there are no officially published regulatory service fees associated with medical devices.
Application Processing Timelines
Unknown as it hasn’t fully started as of now.
Validity of Marketing Authorization Certificate
As per the Authority’s plan now, once product registration becomes mandatory, the Marketing Authorization Certificate is expected to be valid for 5 years.
Renewal applications will be required before expiry.
Variation applications (for changes in manufacturing site, labeling, etc.) must be submitted as per guideline timelines.
Post-registration Regulatory Controls
SAHPRA conducts:
– Vigilance and adverse event monitoring
– Post-market surveillance
– Compliance checks
– Sampling and testing (if necessary)
Manufacturer’s Quality Management System Audit
SAHPRA requires ISO 13485 certification for manufacturers from SAHPRA recognized conformity assessment bodies.
Laboratory Tests
Laboratory testing is not routinely required for market entry unless concerns arise.
For IVDs, testing may be needed if not WHO prequalified or registered with a recognized SRA.
Post-market lab analysis may be conducted as part of surveillance.
How can ETHIOBIOMEDICAL support you to market your medical devices in South Africa?
We will assign one of our best performing partners having local presence in South Africa and having medical device establishment license from SAHPRA to import and distribute medical devices in the country.
We will help you compile required documents to be submitted to SAHPRA through your local authorized representative.
Please click here to contact us for any further information or potential collaborations.
