Our Services

Verion Medical provides integrated regulatory affairs, establishment licensing, ISO 13485 quality systems, import, export, distribution and market development services for medical device and IVD manufacturers and suppliers.

Our Core Services

Six Specialist Services.

[01]

Medical Device & IVD Registration

Build the right product pathway before committing to a submission.

We assess intended use and risk classification, identify technical documentation gaps, review labelling and instructions for use, and support product listing or registration preparations where applicable under South Africa’s evolving regulatory framework.

Our capabilities include:

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[02]

Medical Device Establishment Licensing

The licence held by an establishment must match the activities it performs.

We support SAHPRA manufacturer, distributor and wholesaler licence applications, including documentation preparation, quality-system alignment, renewals, amendments and product-list updates.

Our capabilities include:

Manufacturer, distributor and wholesaler licences
Application preparation and supporting documents
Renewals, amendments and licence maintenance

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[03]

ISO 13485 & Quality Management Systems

A quality management system should be auditable, proportionate and usable.

We support ISO 13485-aligned QMS implementation, quality manuals, standard operating procedures, supplier controls, corrective actions, internal audits and preparation for independent certification assessments.

Our capabilities include:

QMS design and implementation
SOP development, CAPA and internal audits
ISO 13485 certification readiness

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[04]

Medical Device Regulatory Affairs

Regulatory obligations continue beyond an initial submission.

We provide medical device and IVD regulatory strategy, compliance gap assessments, regulatory intelligence, product lifecycle management, authorised representative support where appropriate, and post-market compliance planning.

Our capabilities include:

Regulatory strategy and gap assessments
Local representation services
Post-market regulatory compliance support

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[05]

Import, Export & Distribution

Verion Medical provides import, export and distribution operations to support medical device manufacturers and suppliers entering and operating in the South African market.

Our services encompass regulatory import and export compliance, shipment documentation, logistics coordination, product traceability and distribution controls, supporting efficient and compliant access to the South African healthcare market.

Our capabilities include:

Import and export regulatory readiness
Shipment documentation and coordination
Distribution records, traceability and compliance controls

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[06]

Sales & Market Development

Market access requires more than regulatory preparation.

We support route-to-market planning, distributor and channel assessments, market-development strategy, product launch coordination, tender readiness and focused commercial growth initiatives for medical device and IVD businesses.

Our capabilities include:

Market-entry and channel strategy
Distributor evaluation and partnerships
Launch and tender-readiness support

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Product Classification

Speak to Our Team

The Verion Approach

How we work.

Every engagement is shaped by your product, business model and commercial objectives. We provide focused specialist support or integrated services across the medical device and IVD market-entry lifecycle.

1

We Assess

We evaluate product classification, regulatory requirements, existing approvals and business activities to establish a clear starting point.

2 We Prepare

We define the regulatory pathway and prepare the necessary licensing, technical documentation and quality management requirements.

3 We Execute

We support regulatory submissions, import, export, distribution operations and market-entry activities in line with your business objectives.

4

We Maintain

We support ongoing regulatory compliance, licence maintenance, quality systems and post-market obligations as your operations evolve.

Who We Support

From established international manufacturers to South African distributors and emerging medtech companies, our work is shaped by the client’s product, role and operating model.

Medical Device Manufacturers
IVD & Diagnostics Companies
Distributors, Importers & Wholesalers
Digital Health & Medical Software

Planning to Enter the Medical Device Market?

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Before You Get Started

FREQUENTLY ASKED QUESTIONS

Can Verion Medical act as a legal representative for international medical device and IVD manufacturers?

Yes. Verion Medical offers local legal and regulatory representation services for international medical device and IVD manufacturers entering the South African market. Our support includes regulatory liaison, documentation management, compliance oversight and market-entry coordination.

Do medical devices and IVDs require SAHPRA registration in South Africa?

SAHPRA regulates medical devices and IVDs through establishment licensing and applicable product-level requirements. The broader product registration framework remains under phased development, with requirements varying by product category and classification. Verion Medical assists manufacturers and suppliers with classification, regulatory pathway assessments, product listing requirements and registration readiness.

Can Verion Medical import, export and distribute medical devices in South Africa?

Yes. Verion Medical provides import, export and distribution operations for medical device and IVD manufacturers and suppliers entering and operating in South Africa. Supported by our distribution and wholesale partners, we offer integrated services covering regulatory compliance, shipment coordination, warehousing arrangements, product traceability and distribution management to facilitate compliant and efficient market access.

Does Verion Medical provide SAHPRA establishment licence application support and ISO 13485 compliance services?

Yes. Verion Medical supports medical device manufacturers, distributors and wholesalers with SAHPRA establishment licence applications, regulatory documentation and compliance requirements. We also provide ISO 13485 quality management system implementation, SOP development, gap assessments, internal audits and certification readiness support. ISO 13485 certification is issued by independent certification bodies.

Our Thinking