SAHPRA Medical Device Licence Fees and Costs

Published: 11 April 2023
Last updated: 16 October 2026

The cost of a SAHPRA medical device establishment licence depends primarily on whether the applicant is applying as a manufacturer, distributor or wholesaler, and whether the submission is a new application, renewal or amendment.

The South African Health Products Regulatory Authority, or SAHPRA, charges statutory fees for medical device establishment licensing under the Medicines and Related Substances Act. The fee structure is published through regulation and can change over time.

As at this article’s 16 October 2026 update, SAHPRA lists the application fee for a new manufacturer licence at R26,200, while a new distributor or wholesaler licence application costs R15,600. A separate R3,500 licence issuing fee, also referred to as a collection fee, is listed once the licence application has been approved.

That means the statutory SAHPRA charges associated with obtaining a new licence can start at approximately R29,700 for a manufacturer and R19,100 for a distributor or wholesaler, before considering annual retention fees, quality-system implementation, ISO 13485 certification, professional support or other business costs.

Understanding these different cost components is important when budgeting for South African medical device market entry.

What are the current SAHPRA medical device licence fees?

SAHPRA’s current medical device establishment licensing guidance lists separate fees for new licence applications, renewals, amendments, licence issuing and annual retention.

For new applications, the current statutory fees are:

Manufacturer licence application: R26,200
Distributor licence application: R15,600
Wholesaler licence application: R15,600

For other licensing activities, SAHPRA lists:

Licence amendment application: R5,500
Licence issuing or collection fee: R3,500
Manufacturer licence renewal: R22,900
Distributor licence renewal: R13,100
Wholesaler licence renewal: R13,100
Annual retention fee: R4,400
Product-list notification: R0

SAHPRA warns that fees can be updated and that applicants are responsible for checking the current fee structure before payment.

SAHPRA introduced an updated fee dispensation through regulations gazetted on 12 February 2025, with the new fee structure taking effect on 13 February 2025.

Manufacturer licence fees

A new SAHPRA medical device manufacturer licence currently carries an application fee of R26,200.

Once the application is approved, SAHPRA separately lists a R3,500 licence issuing fee.

On that basis, a new manufacturer should allow for approximately R29,700 in direct SAHPRA application and issuing charges.

That figure does not represent the complete cost of becoming a licensed medical device manufacturer.

Additional costs may include QMS implementation, ISO 13485 certification, regulatory documentation, facility controls, staff training, supplier qualification and professional application support.

Our dedicated guide on the Medical Device Manufacturer Licence in South Africa explains the manufacturer pathway in greater detail.

Distributor licence fees

A new SAHPRA medical device distributor licence application currently costs R15,600.

When the separate R3,500 issuing fee is added following approval, the direct SAHPRA charges associated with a new distributor licence are approximately R19,100.

A distributor may also need an appropriate quality management system, product classification work, product-list preparation, an Authorised Representative, compliant storage and distribution arrangements and, where applicable, ISO 13485 certification.

Our guide on choosing between a manufacturer, distributor and wholesaler licence explains how the licence types differ.

Wholesaler licence fees

A new medical device wholesaler licence currently carries an application fee of R15,600.

The separate R3,500 issuing fee means the direct statutory cost associated with obtaining a new wholesaler licence is approximately R19,100, before other implementation expenses.

Distributor and wholesaler licences are not interchangeable simply because their application fees are the same.

The correct licence should be selected according to the company’s actual activities.

Our dedicated article, Medical Device Wholesale Licence in South Africa: SAHPRA Requirements, explains the wholesaler pathway separately.

What is the SAHPRA licence issuing fee?

SAHPRA currently lists a R3,500 licence issuing fee, also described as a collection fee.

This fee is payable after SAHPRA has communicated approval and before the approved licence is issued.

Companies preparing budgets should therefore not treat the initial application fee as the complete statutory cost of obtaining the licence.

How much does a medical device licence renewal cost?

SAHPRA currently lists the following renewal application fees:

Manufacturer renewal: R22,900
Distributor renewal: R13,100
Wholesaler renewal: R13,100

A renewal application should be submitted at least 90 days before the existing licence expires.

Companies should therefore link renewal budgeting to a formal regulatory calendar rather than waiting until the licence is close to expiry.

Our dedicated guide, How Long Does a SAHPRA Medical Device Licence Take?, addresses licensing timelines separately.

What does a licence amendment cost?

The current medical device establishment licence amendment fee is R5,500.

An amendment may be necessary where information associated with the issued licence changes, including certain company, address, personnel or activity details.

Not every change is necessarily an amendment. The regulatory impact of the proposed change should be assessed before submission.

Are product-list notifications charged?

SAHPRA currently lists the fee for a notification as R0.

This is particularly relevant to appropriate product-list changes that do not alter information requiring a formal licence amendment.

A company should not automatically pay for an amendment where the regulatory change properly qualifies for notification.

Equally, a substantive amendment should not be submitted as a notification simply because the notification has no statutory fee.

What is the annual licence retention fee?

SAHPRA currently lists an annual medical device establishment licence retention fee of R4,400.

The retention fee is separate from the original licence application fee and eventual renewal fee.

It forms part of the ongoing statutory cost of maintaining an existing medical device establishment licence.

When is the annual retention fee payable?

SAHPRA’s 2026 retention communication states that annual retention fees are payable on or before the last working day of 30 June of the applicable year.

Failure to pay the applicable retention fee may lead to cancellation of the licence.

The licensing guidance also indicates that annual retention becomes relevant from the year following licence approval.

Companies should therefore include retention deadlines within their regulatory compliance calendar.

Why older SAHPRA documents show different fees

Companies searching online may encounter different medical device licence fees because the statutory amounts have changed over time.

For example, older guidance listed R25,200 for a manufacturer application and R15,000 for distributor and wholesaler applications.

Updated fee regulations were gazetted on 12 February 2025 and took effect from 13 February 2025.

Applicants should therefore confirm the current fee immediately before payment rather than relying on an old PDF, quotation or saved application guide.

Are SAHPRA fees the full cost of obtaining a licence?

No.

The statutory SAHPRA fee is only the amount payable to the regulator for the relevant licensing activity.

Additional costs may include:

regulatory application preparation;
product classification;
product-list preparation;
Quality Management System implementation;
Quality Manual or Site Master File development;
SOP development;
internal audits;
ISO 13485 certification;
training;
Authorised Representative resources;
facility or warehousing preparation;
monitoring equipment;
calibration or validation;
supplier qualification; and
quality agreements.

The SAHPRA fee should therefore be viewed as one component of the overall establishment licensing budget.

ISO 13485 and quality-system costs

For manufacturers and distributors, quality-system readiness can be one of the most important non-SAHPRA costs.

ISO 13485 expenditure can include both QMS implementation and independent external certification.

Certification costs are charged by the conformity assessment body rather than by SAHPRA and can vary according to organisation size, scope, number of sites, complexity and audit duration.

For more information, see ISO 13485 in South Africa: Requirements for Medical Device Companies or Verion Medical’s ISO 13485 and Quality Management Systems services.

Authorised Representative and personnel costs

A medical device establishment requires an appropriately appointed Authorised Representative.

The role carries regulatory responsibilities and should be supported by appropriate resources, competence and authority.

Companies should therefore consider personnel, training and regulatory oversight costs as part of the wider establishment licensing budget.

Our article on SAHPRA Authorised Representative requirements and responsibilities explains the role in greater detail.

Warehousing and outsourced service costs

Medical device establishments may outsource warehousing, transport, calibration, servicing and other regulated or quality-critical activities.

These arrangements should be considered during establishment licensing and QMS planning.

The cost of a licensing project can therefore vary depending on whether the applicant operates its own compliant infrastructure or relies on third-party service providers.

Does each licence have its own fees?

A company may hold more than one establishment licence where justified by its activities.

However, fees and annual retention obligations apply to the licences held.

Multiple licences should therefore not be obtained unnecessarily.

For example, a manufacturer licence can encompass certain import, export and distribution activities, which may make a separate distributor licence unnecessary for the same establishment.

See Manufacturer, Distributor or Wholesaler? Choosing the Right SAHPRA Licence for a detailed comparison.

What happens if the wrong fee is paid?

Applicants are responsible for ensuring that the correct current fee is paid.

Before making payment, confirm the licence type, application type and current SAHPRA fee structure.

Retain proof of payment and include it with the applicable submission.

Regulatory pathway assessment should take place before payment, because paying a particular fee does not change the regulatory nature of the application.

How should companies budget for establishment licensing?

For a new manufacturer, the current starting statutory amount is approximately R29,700, consisting of the R26,200 application fee and R3,500 issuing fee.

For a new distributor or wholesaler, the equivalent starting statutory amount is approximately R19,100.

The organisation should then budget for relevant QMS, ISO 13485, regulatory, facility, personnel and operational costs.

Provision should also be made for the R4,400 annual retention fee and the eventual renewal application.

For international manufacturers, regulatory budgeting should form part of the wider medical device market-entry strategy for South Africa.

Key SAHPRA references

How Verion Medical supports SAHPRA establishment licensing

Verion Medical supports manufacturers, distributors and wholesalers with the regulatory and quality activities required to obtain and maintain a South African medical device establishment licence.

Our medical device establishment licensing services include licence pathway assessments, new licence applications, regulatory readiness reviews, amendments, renewals, product-list preparation, Authorised Representative requirements and supporting documentation.

Where a company also needs quality-system preparation, Verion Medical provides ISO 13485 and Quality Management Systems support, including QMS implementation, Quality Manuals, SOPs, internal audits and certification readiness.

Our broader support includes device classification, medical device regulatory affairs and import and export support.

The statutory SAHPRA fee is only one part of a successful licensing project. The more important objective is ensuring that the licence type, products, QMS, facilities, personnel and outsourced activities all support the same compliant operating model.

If your organisation is budgeting for a new SAHPRA medical device establishment licence, renewal or amendment, contact Verion Medical to assess the applicable licensing pathway and readiness requirements.