South Africa’s medical device regulatory landscape has undergone significant change over the past decade, and the pace of that change is accelerating. The South African Health Products Regulatory Authority (SAHPRA) is systematically expanding its oversight of medical devices — moving away from the relatively light-touch licensing framework that existed under the Medicines and Related Substances Act 101 of 1965 toward a risk-based, internationally harmonised regulatory system.
For manufacturers and importers operating in South Africa, understanding what is currently required — and what is coming — is essential for maintaining market access and avoiding enforcement action.
This guide covers the current SAHPRA framework for medical devices, what licences and registrations are required, where ISO 13485 fits in, and what a practical compliance programme looks like for small to mid-size companies.
The regulatory framework: where South Africa currently stands
Medical devices in South Africa are regulated under the Medicines and Related Substances Act 101 of 1965, as amended, and the Medical Devices and In Vitro Diagnostic Devices Regulations published under that Act. SAHPRA, established in 2018 as the successor to the former Medicines Control Council (MCC), is the competent authority.
South Africa adopted a risk-based classification system aligned with the Global Harmonisation Task Force (GHTF) / International Medical Device Regulators Forum (IMDRF) framework:
- Class A — lowest risk (e.g. bandages, tongue depressors)
- Class B — low to moderate risk (e.g. hypodermic needles, non-absorbable sutures)
- Class C — moderate to high risk (e.g. ventilators, haemodialysis machines)
- Class D — highest risk (e.g. implantable cardiac pacemakers, HIV test kits)
Classification determines the conformity assessment pathway, the level of regulatory scrutiny, and whether Notified Body or SAHPRA review is required.
Licences required to operate
Before any medical device can be manufactured, imported, distributed, or sold in South Africa, the company must hold the appropriate establishment licence issued by SAHPRA. The licence categories relevant to most small companies are:
Manufacturing licence. Required for any company manufacturing medical devices in South Africa, including companies that assemble, repackage, relabel, or sterilise devices. Manufacturing licence applications require evidence of a quality management system, facility details, and a list of devices to be manufactured.
Import licence. Required for any company importing medical devices into South Africa for the purpose of sale or distribution. This is a separate licence from a manufacturing licence — holding one does not confer the other.
Distribution licence (wholesale). Required for wholesale distributors of medical devices. Companies distributing their own imported devices need both an import licence and a distribution licence unless the import licence explicitly covers distribution.
Retail licence. Required for pharmacies and retail outlets selling medical devices directly to end users. Most medical device businesses operate on the wholesale side and do not require a retail licence.
Licence applications are submitted through SAHPRA’s online portal. Incomplete applications are the single most common cause of delay — a well-prepared application with all supporting documentation submitted at the outset materially reduces turnaround time.
Product registration: what is required and when
Class C and Class D devices are subject to mandatory product registration with SAHPRA, however it is important to note that full enforcement is still being phased in. SAHPRA is currently conducting a pilot registration feasibility study for selected high-risk devices and IVDs — including HIV and TB tests — which was updated in March 2026. A formal Registration Call-Up Plan specifying which devices are prioritised for registration, and by when, has not yet been published. Companies with Class C and D products should be preparing registration dossiers now, but should monitor SAHPRA’s Registration Call-Up Plan for the formal enforcement timeline applicable to their specific device category.
Where ISO 13485 fits in
ISO 13485:2016 is the quality management system standard referenced by SAHPRA in its conformity assessment requirements, and it is being phased in as a mandatory requirement on a defined timeline. As of April 2026, all existing establishment licence holders must have an ISO 13485 certificate available for SAHPRA verification during audits, product-complaint investigations, or vigilance activities. From June 2027, ISO 13485 certification will be required for all licence amendments and product-list updates. From April 2028, all new licence applications must include an ISO 13485 certificate. For companies renewing their licence, the requirement has applied since June 2025. This is not a future obligation — for most licence holders, it is a current one.
SAHPRA inspections: what to expect
SAHPRA conducts facility inspections for manufacturing licence applicants and as part of post-licence surveillance. The inspection programme has become materially more active since 2020, and SAHPRA’s inspection teams are increasingly experienced and technically capable.
An inspection typically covers:
- Quality management system implementation (document control, CAPA, internal audit, management review)
- Facility and equipment suitability for the devices manufactured
- Personnel qualifications and training records
- Production and process controls
- Complaint handling and post-market surveillance
- Record-keeping and traceability
Companies that have a functioning ISO 13485 QMS in place — not merely documented but actively used — consistently perform better in SAHPRA inspections than those that have assembled paper systems without genuine implementation.
Particular considerations for importers
South African medical device importers face a compliance challenge that manufacturers sometimes underestimate: they are responsible for the regulatory standing of every product they import, but they control neither the manufacturing process nor the technical documentation.
Supplier qualification. Import licence conditions require that the manufacturer holds an appropriate manufacturing licence or equivalent approval in their home country. Importers should obtain and maintain evidence of this — manufacturing licence, ISO 13485 certificate, CE mark or equivalent — and re-verify at defined intervals.
Technical file access. For Class C and D registration, the importer must be able to provide SAHPRA with the technical file. This requires a written agreement with the manufacturer granting access to that documentation. Importers who have not secured this agreement before applying for registration frequently encounter delays when SAHPRA requests documents they cannot readily obtain.
Labelling compliance. SAHPRA has specific labelling requirements for medical devices placed on the South African market, including South African contact details on the label or in accompanying documentation.
Post-market surveillance obligations. Importers must report serious incidents and field safety corrective actions (recalls) to SAHPRA within defined timeframes. A complaint handling and incident reporting procedure is not optional — it is a licence condition.
Building a compliance programme: where to start
For companies that are not yet fully compliant, the most effective starting point is a structured gap analysis. This produces a clear, prioritised picture of the current compliance position across all relevant dimensions — licensing, QMS, product registration, labelling, post-market surveillance — and forms the basis for a realistic remediation plan.
Common priorities that emerge from gap analyses of South African medical device companies:
- Licensing gaps — operating on an incomplete or incorrect licence category
- QMS documentation exists but is not implemented or maintained
- Class C/D products being sold without current registration
- No written supplier agreements covering technical file access
- Post-market surveillance processes are absent or nominal
- Labelling non-compliance with SAHPRA requirements
Addressing these in a structured, documented programme — rather than reactively in response to an inspection or enforcement notice — keeps costs manageable and avoids the business disruption that enforcement action creates.
Vesta Consulting works with South African medical device manufacturers and importers on SAHPRA licensing, ISO 13485 certification readiness, product registration, and inspection preparation. Get in touch to discuss your compliance position.
Key references
– Medicines and Related Substances Act 101 of 1965 (as amended)
– Medical Devices and IVD Regulations, Government Gazette No. 40480, 2017
– SAHPRA Guidance: Classification of Medical Devices and IVDs
– SAHPRA Guidance: Application for Establishment Licence — Medical Devices
– ISO 13485:2016 — Medical devices — Quality management systems
– IMDRF/SaMD N11 — Risk Categorisation of Software as a Medical Device
Tesha Hiralal is the founder of Vesta Consulting and a BSI-certified ISO 13485 Lead Auditor (CQI/IRCA). She holds an MSc in Regulatory Affairs and a B.Pharm (Hons), and is a former SAHPRA Medicines Control Officer and Inspector.
