Medical Device & IVD Registration

Specialist support for medical device registration in South Africa, from regulatory pathway assessments and product listing to technical documentation and registration readiness.

Product Regulatory Services

Establishing the Right Regulatory Pathway.

Medical device and IVD market entry requires a clear understanding of product classification, applicable SAHPRA requirements and the regulatory evidence needed to support market access.

Verion Medical supports medical device and IVD manufacturers and suppliers with product regulatory assessments, documentation reviews, SAHPRA product-listing support and registration preparation.

Our Medical Device & IVD Registration Services

Regulatory Pathway Assessment

Assessment of product intended use, regulatory status and applicable SAHPRA requirements to establish the appropriate compliance and registration pathway for South Africa.

Medical Device & IVD Classification

Review of device risk classification and classification rationale under the applicable SAHPRA rules, including identification of matters requiring further regulatory assessment.

Product Listing & Portfolio Management

Preparation, review and maintenance of medical device and IVD product information for SAHPRA establishment licence product lists, including applicable updates and notifications.

Technical Documentation Review

Assessment of available technical files, product specifications, safety and performance evidence, and supporting regulatory documentation to identify gaps against applicable requirements.

International Regulatory Evidence

Review of existing international product approvals, conformity assessments and regulatory evidence to determine their relevance to South African requirements and potential reliance pathways.

Registration Readiness & Submission Support

Preparation of product documentation, registration readiness assessments and support for applicable SAHPRA submissions, regulatory correspondence and responses to authority queries.

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Specialist Services

Dedicated Expertise for Product Registration

01.

Medical Device & IVD Classification

Establish the appropriate risk classification for your medical device or IVD based on intended purpose, applicable classification rules and product characteristics..
02.

Technical Documentation & Labelling

Prepare and assess product technical documentation, labelling and instructions for use against applicable South African regulatory and safety requirements.

Why Verion Medical?

1

Clear Regulatory Direction

Understand what SAHPRA requires for your medical device or IVD, with practical guidance that helps you make informed decisions.
2

Fewer Delays and Unnecessary Costs

Identify documentation gaps and potential compliance issues early, reducing avoidable rework and unnecessary expenditure.
3

Support Beyond Registration

Work with a partner who understands how product registration, establishment licensing, quality systems and distribution fit together in the market.

Have a Medical Device or IVD Portfolio to Assess?
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Before You Get Started

FREQUENTLY ASKED QUESTIONS

1. Does CE marking or US FDA clearance automatically qualify a medical device for the South African market?
No. CE marking or US FDA authorisation does not automatically constitute South African regulatory authorisation. Although SAHPRA recognises certain international regulatory decisions within its reliance framework, manufacturers and suppliers must still meet applicable South African requirements.
Verion Medical reviews existing international approvals and supporting documentation to determine their relevance to product listing, regulatory compliance and registration preparation.
Documentation requirements depend on the product, its intended purpose, risk classification and applicable regulatory pathway. Relevant records may include product descriptions, GMDN information, technical documentation, labelling, instructions for use, evidence of safety and performance, and international regulatory approvals.
Verion Medical assists with documentation gap assessments and preparation of regulatory evidence appropriate to the product and applicable SAHPRA requirements.
An establishment licence holder may need to submit a product-list notification or licence amendment, depending on the nature of the change. Additions within an already-approved device class may qualify for notification, while changes affecting the approved licence scope or certain specified IVD products may require an amendment.
Verion Medical supports product-list reviews, documentation preparation and the identification of the appropriate submission process.
Yes. Manufacturers can undertake regulatory readiness assessments, review product classification, consolidate technical documentation and evaluate existing international approvals before broader product registration requirements take effect.
Verion Medical assists manufacturers in identifying documentation gaps and establishing a structured registration preparation programme aligned with current SAHPRA guidance and regulatory developments.

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Related Medical Device & IVD Services

Medical Device Establishment LicensingImport, Export & Distribution
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Medical Device Regulatory AffairsIVD Regulatory Support

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Let Verion Medical assess your product portfolio and define the applicable regulatory requirements.

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