Medical Devices & IVDs

Compliant.
Connected.
Commercial.

The specialist regulatory and market access partner that takes your device from first classification to first patient.

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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.

Verion Medical - Happy Patient

Our Services

Medical Device & IVD Registration

Medical device and IVD product registration, including device classification, technical documentation, regulatory submissions and application management.

Product Registration

Medical Device Establishment Licensing

SAHPRA Establishment licensing application preparation and submission support for manufacturers, importers, exporters, distributors and wholesalers of medical devices and IVDs.

Establishment Licensing

ISO 13485 & Quality Management Systems

ISO 13485 quality management systems, implementation, site internal audits, SOPs and SMF development, certification preparation and ongoing quality compliance.

ISO 13485 Services

Medical Device Regulatory Affairs

Regulatory planning, regulatory documentation, product lifecycle management and regulatory compliance for medical devices and IVDs.

Regulatory Affairs

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.

Import & Distribution

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.

Sales & Market Development
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Verion Medical - Medical Device Client Engagement

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.

Verion Medical - Who We support

Who We Support

Verion Medical works with established businesses, new market entrants and international companies across the medical device and IVD sector.

  • Medical Device & IVD Manufacturers
  • Distributors & Wholesalers
  • Digital Health & Medical Software
  • Healthcare & Diagnostic Businesses
  • Importers & Exporters
  • Start-ups & Emerging MedTech Companies

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.

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Before You Get Started

FREQUENTLY ASKED QUESTIONS

Do medical devices and IVDs need to be registered?
Registration requirements depend on the product, its classification and the regulatory requirements applicable to that product category. A regulatory assessment should establish the applicable route before an application is prepared.
Establishment licensing applies to businesses undertaking regulated medical device activities such as manufacturing, importing, exporting, distributing and wholesaling, subject to the applicable regulatory requirements.
Yes. Verion Medical assists manufacturers, importers, exporters, distributors and wholesalers with SAHPRA medical device establishment licence applications in South Africa. Our support includes application preparation, product-list development, supporting regulatory documentation, quality management system requirements, submission support and responses to SAHPRA queries throughout the licensing process.
Yes. We provide ISO 13485 quality management system implementation for medical device and IVD companies in South Africa. Our support can include quality manuals, SOPs, forms and records, document control, risk management, internal audits, staff training and preparation for ISO 13485 certification. Certification is conducted independently by an accredited certification body.
Yes. Verion Medical assists with medical device and IVD classification in South Africa in accordance with applicable SAHPRA requirements. We review the intended purpose, product characteristics and applicable classification rules to determine the appropriate risk class and regulatory pathway for the device or IVD.
Yes. We support companies with the importation, export and distribution of medical devices and IVDs in South Africa. This can include regulatory requirements, import and export documentation, permits where applicable, product records, customs-related documentation, distributor compliance and ongoing regulatory support.
Yes. Verion Medical provides medical device commercialisation, sales and market development support in South Africa. Services can include market-entry planning, go-to-market strategy, distributor and channel development, sales representation, product launches, tender support and business development for medical device and IVD companies entering or expanding in the South African market.

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