Medical Device Establishment Licensing

SAHPRA licence application support for medical device and IVD manufacturers, distributors and wholesalers in South Africa, from initial applications to amendments, renewals and ongoing licence compliance.

Establishment Licensing

The Right Licence for Your Business Activities.

SAHPRA medical device establishment licensing is determined by the activities a business performs. Manufacturing, importing, exporting, distribution and wholesaling carry different licensing responsibilities, with requirements relating to personnel, facilities, product listings and quality documentation.

Verion Medical assists medical device and IVD companies with establishment licence applications, regulatory documentation and ongoing licence maintenance.

Our Medical Device Establishment Licensing Services

Licence Type & Scope Assessment

Assessment of business activities, establishment arrangements and intended product categories to identify the appropriate SAHPRA licence type and scope before applying.

Manufacturer Licence Applications

Preparation and submission support for medical device and IVD manufacturers, including businesses involved in manufacturing, assembly, packaging, labelling, refurbishment and other regulated manufacturing activities.

Distributor Licence Applications

SAHPRA medical device distributor licence application support for businesses intending to import, export or distribute medical devices and IVDs in South Africa.

Wholesaler Licence Applications

Licensing assistance for medical device wholesalers involved in local procurement, storage, transportation and wholesale supply, including review of establishment and operational arrangements.

Licensing Documentation & Quality Requirements

Preparation and review of establishment application documentation, including Quality Manuals, Site Master Files, product lists, personnel records and relevant quality-system evidence.

Licence Renewals, Amendments & Maintenance

Support for establishment licence renewals, changes to approved licence details, product-list notifications and ongoing licence administration as business activities evolve.

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Specialist Licensing Support

Dedicated Support for Establishment Licensing

01.

Medical Device Manufacturer Licensing

Establish the appropriate SAHPRA manufacturing licence requirements, including the scope of manufacturing activities, facility documentation and application preparation.
02.

Medical Device Wholesaler Licensing

Navigate SAHPRA wholesaler licence requirements, including storage and distribution arrangements, establishment documentation and operational compliance.
03.

QMS & Site Master File

Prepare the quality documentation required for medical device establishment licensing, including Quality Manuals, Site Master Files and supporting operational procedures.

Why Verion Medical?

1

Avoid Applying for the Wrong Licence

Understand which SAHPRA establishment licence applies to your business before committing time and resources to an application.
2

Reduce Avoidable Application Queries

Identify missing documents, inconsistencies and licensing gaps before submission, reducing unnecessary corrections and rework.
3

Stay Compliant as Your Business Changes

Keep licence details aligned with changes to your operations, personnel, premises and approved activities.

Applying for a SAHPRA Medical Device Licence?
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Before You Get Started

FREQUENTLY ASKED QUESTIONS

1. Which SAHPRA medical device establishment licence does my company need?
SAHPRA issues three principal medical device establishment licence types: manufacturer, distributor and wholesaler.
The appropriate licence depends on the activities performed. Manufacturer licences cover regulated manufacturing activities, distributor licences cover importing, exporting and distributing, while wholesaler licences cover applicable local wholesale, storage and supply activities.
Verion Medical assesses your intended operations to help determine the appropriate licence type and application scope.Verion Medical reviews existing international approvals and supporting documentation to determine their relevance to product listing, regulatory compliance and registration preparation.
SAHPRA generally requires a completed application form, signed cover letter, proof of payment, Authorised Representative details and CV, product listings and relevant quality documentation.
Manufacturers and distributors are generally required to provide a Quality Manual, while wholesalers submit a Site Master File. ISO 13485 certification evidence may also be required, depending on the licence type and applicable implementation phase.
Verion Medical assists with documentation preparation, review and application submission to ensure the relevant requirements are addressed.
SAHPRA is implementing ISO 13485 certification requirements through a phased programme for medical device manufacturers and distributors.
Certification requirements already apply to relevant licence renewals, with further implementation phases covering amendments and new applications. The applicable evidence depends on the application type, timing and current SAHPRA requirements.
Verion Medical helps companies determine the quality documentation and certification evidence relevant to their establishment licence applications.
Yes, subject to the applicable licensing requirements.
SAHPRA permits contracted operational arrangements, but third parties performing regulated manufacturing, distribution or wholesale activities must hold the appropriate establishment licences where required.
The licence holder must also maintain appropriate oversight of outsourced activities and ensure that relevant responsibilities, quality controls and operational arrangements are documented.
Verion Medical assists with assessing these arrangements and their implications for establishment licensing.
SAHPRA indicates an estimated application processing period of approximately six to eight weeks, depending on submission completeness, applicant responses and regulatory review requirements.
Existing establishment licence holders must also submit renewal applications at least 90 days before licence expiry.
Verion Medical supports application planning, documentation readiness and regulatory correspondence throughout the licensing process.

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Related Medical Device & IVD Services

Medical Device & IVD RegistrationImport, Export & Distribution
ISO 13485 & Quality Management SystemsSales & Market Development
Medical Device Regulatory AffairsMarket Entry & Distribution Access

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Have your licence scope and application requirements reviewed before submission.

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