About Verion Medical
A specialist market access & regulatory partner for medical devices & IVDs.
We support local and international medical device and IVD manufacturers, distributors and wholesalers in navigating regulatory requirements, establishing compliant operations and accessing the South African market.
Our Services
Medical Device & IVD Registration
Medical device and IVD product registration, including device classification, technical documentation, regulatory submissions and application management.
Medical Device Establishment Licensing
SAHPRA Establishment licensing application preparation and submission support for manufacturers, importers, exporters, distributors and wholesalers of medical devices and IVDs.
ISO 13485 & Quality Management Systems
ISO 13485 quality management systems, implementation, site internal audits, SOPs and SMF development, certification preparation and ongoing quality compliance.
Medical Device Regulatory Affairs
Regulatory planning, regulatory documentation, product lifecycle management and regulatory compliance for medical devices and IVDs.
Import, Export & Distribution
Import, export and distribution support for medical devices and IVDs, including regulatory and customs documentation, permits, product records, distributor compliance and cross-border coordination.
Sales & Market Development
Commercial support for medical device and IVD companies entering and growing in the market, including go-to-market strategy, channel development, sales representation, product launches and tender support.
Why Verion Medical
Built specifically around medical devices and IVDs
Specialist regulatory, quality and commercial expertise for companies operating in and entering the market.
Authorised Representative
Local representation for international medical device and IVD manufacturers, including regulatory liaison and ongoing product compliance.
From Registration to Market
One team across product registration, establishment licensing, ISO 13485, import, distribution and commercial launch.
Market Access Expertise
Connecting regulatory requirements with the commercial realities of bringing medical devices and IVDs to market.
Who We Support
Verion Medical works with established businesses, new market entrants and international companies across the medical device and IVD sector.
Risk Profile
SAHPRA Classification of Medical Devices
Class A
Low risk
Generally includes non-invasive devices and certain reusable instruments with a lower potential for harm.
Class B
Low-moderate risk
Generally includes devices with a greater degree of patient contact, invasiveness or interaction with active medical equipment.
Class C
Moderate-high risk
Generally includes devices where their use, invasiveness or function presents a greater potential for serious harm to the patient.
Class D
High risk
The highest risk class, including certain implantable, life-supporting, cardiovascular and other devices presenting significant patient or public-health risk.
Not sure how your device is classified?
Request a classification assessment.
Before You Get Started
FREQUENTLY ASKED QUESTIONS
Our Thinking
News & Insights
Medical Devices and IVDs in South Africa: The Regulatory Framework Explained
Published: 12 September 2023 Last updated: 30 September 2026 Medical devices and IVDs in South…
SAHPRA Medical Device Reliance Pathway: What Manufacturers Need to Know
Regulatory reliance is becoming increasingly important for manufacturers seeking to place medical devices and in…
Medical Device Registration in South Africa: SAHPRA Requirements
Medical device registration in South Africa is often misunderstood because the country’s regulatory framework combines…
Medical Device Classification in South Africa: Classes A, B, C and D
Medical device classification in South Africa is based on risk. Every medical device and in…