A SAHPRA medical device establishment licence is a central regulatory requirement for companies that manufacture, import, export, distribute or wholesale medical devices and in vitro diagnostic medical devices, or IVDs, in South Africa.
The licensing requirement operates at establishment level. It is intended to give the South African Health Products Regulatory Authority, or SAHPRA, visibility over the organisations performing regulated medical-device activities, the classes of products they handle and the quality systems supporting those activities.
For companies establishing a South African medical-device operation, the licence application should therefore not be treated as a simple administrative form. The applicant must determine the correct licence type, establish its product scope, appoint an appropriate Authorised Representative, implement a documented quality management system and submit supporting information that accurately reflects the way the business will operate.
What is a SAHPRA medical device establishment licence?
A medical device establishment licence authorises an establishment to perform defined regulated activities involving medical devices or IVDs.
The licensing framework arises from section 22C of the Medicines and Related Substances Act and the Regulations Relating to Medical Devices and In Vitro Diagnostic Medical Devices.
SAHPRA’s licensing framework allows the Authority to identify manufacturers operating in South Africa, persons importing and distributing medical devices, the risk classifications of products being handled and the controls applied to imported devices.
This is different from the registration of an individual medical device.
An establishment licence concerns the organisation and its authorised activities. Product registration concerns the regulatory status of a particular medical device or IVD.
Companies that need to understand this distinction in more detail can review our guide to medical device registration in South Africa.
Verion Medical also provides dedicated SAHPRA medical device establishment licensing support for companies setting up or changing regulated medical-device operations in South Africa.
Who needs a medical device establishment licence?
As at February 2024, SAHPRA’s licensing framework requires establishments performing relevant activities involving Class B, Class C and Class D medical devices or IVDs to hold the appropriate establishment licence.
The requirement is driven by the activity being performed, not simply by the company’s commercial title.
A company calling itself an agent, supplier, representative or logistics company still needs to examine what it actually does.
For example, a company may require licensing if it:
- manufactures medical devices locally;
- imports finished medical devices into South Africa;
- distributes imported products;
- exports medical devices;
- repackages or relabels medical devices;
- services or refurbishes devices;
- purchases devices locally and supplies them onward as a wholesaler; or
- performs other activities that fall within the regulatory definitions.
Packaging, labelling, servicing and refurbishment may constitute manufacturing activities for licensing purposes.
This is why the licence assessment should begin with an operational review of the business rather than with the application form.
Manufacturer, distributor and wholesaler licences
SAHPRA recognises three types of medical device establishment licence:
Manufacturer licence
Distributor licence
Wholesaler licence
The correct licence depends on the activities carried out by the establishment.
Manufacturer licence
A manufacturer licence is required where the establishment conducts manufacturing activities.
Manufacturing is broader than producing a device from raw materials. It can include design, assembly, processing, reprocessing, packaging, repackaging, labelling and refurbishment.
The manufacturer licence can also encompass import, distribution and export activities associated with the establishment.
Companies carrying out local manufacturing activities can review our dedicated article on the medical device manufacturer licence in South Africa.
Distributor licence
A distributor licence is appropriate where the establishment imports, exports or distributes medical devices.
This is particularly relevant to South African companies appointed by overseas manufacturers to bring products into the country and supply the local market.
A distributor should therefore assess not only its sales role, but also who will act as importer, who will hold stock, who will control regulatory records and who will manage post-market responsibilities.
Wholesaler licence
A wholesaler licence applies where the company procures products from a local manufacturer or distributor and supplies them onward.
A wholesaler licence does not permit the holder itself to import or export medical devices, although a wholesaler may store products for an approved manufacturer or distributor.
For a dedicated explanation of this licence type, see Medical Device Wholesale Licence in South Africa: SAHPRA Requirements.
How to choose the correct SAHPRA licence
Choosing between manufacturer, distributor and wholesaler licences requires an assessment of the full operating model.
A business should consider where products originate, who imports them, whether any relabelling or repackaging takes place, where stock is stored, whether devices are serviced or refurbished and who supplies the final customer.
The company’s licence should reflect its actual activities.
For example, a company that imports devices and then distributes them locally would generally look to the distributor licensing pathway.
A company that purchases products from an already licensed South African distributor and sells them onward without importing them may fall into the wholesaler pathway.
A company that performs relabelling, refurbishment or other activities treated as manufacturing should consider a manufacturer licence even if it also performs distribution.
Our separate guide, Manufacturer, Distributor or Wholesaler? Choosing the Right SAHPRA Licence, examines this decision in greater depth.
The role of the Authorised Representative
Every medical-device establishment licence application requires an Authorised Representative.
The Authorised Representative is a natural person resident in South Africa who has a written mandate to represent the establishment and who carries defined regulatory responsibilities relating to the medical device or IVD.
The role is therefore substantive.
The Authorised Representative should understand the company’s activities, products and quality system and have sufficient authority to support compliance with the regulatory framework.
The applicant must provide the Authorised Representative’s details as part of the licence application, and a curriculum vitae forms part of the supporting documentation.
For a deeper discussion of this role, see SAHPRA Authorised Representative: Requirements and Responsibilities.
Product classification and product listings
Medical-device classification and establishment licensing are closely connected.
When applying for a licence, the applicant must provide details of the medical devices or IVDs it intends to manufacture, import, distribute or otherwise handle.
Relevant product information includes the device or product family name, Global Medical Device Nomenclature code, risk classification and applicable manufacturer information.
South Africa uses Classes A, B, C and D.
The licensing scope should therefore be prepared only after the applicant has considered the classification of its products.
Our detailed guide to medical device classification in South Africa explains the Class A to D framework, while Verion Medical provides device classification support.
As at the publication date of this article, SAHPRA’s licensing guidance stated that persons dealing only with Class A devices were exempt from the establishment licence requirement until further notice.
Companies considering reliance on a Class A exemption should nevertheless review the specific product characteristics and applicable SAHPRA position statements.
The Class A exemption is addressed separately in Do Class A Medical Devices Need a SAHPRA Licence?
Quality Management System requirements
A medical device establishment licence is closely linked to the quality system supporting the establishment’s activities.
An applicant must implement and maintain a documented Quality Management System relevant to the applicable stages of the medical-device lifecycle.
For manufacturers and distributors, the Quality Manual should describe the documented QMS in operation.
This includes information about the organisation, facilities, key personnel, quality policies, procedures, work instructions, document and record controls, supplier controls, complaint handling, adverse-event processes, recalls, change control, internal audits, management review, training, storage and distribution.
As at February 2024, SAHPRA’s Quality Manual guidance required manufacturers and distributors to structure the documented QMS in alignment with the ISO 13485 framework.
Our article on ISO 13485 in South Africa deals separately with the evolution and application of ISO 13485 requirements.
Verion Medical also provides ISO 13485 and Quality Management Systems support for medical-device establishments.
Documents required for a SAHPRA licence application
A business-as-usual establishment licence application should be submitted as a complete application package.
Key supporting documents include:
- a signed cover letter on company letterhead;
- the completed licence application;
- proof of payment;
- the Authorised Representative’s curriculum vitae;
- a Quality Manual for manufacturers and distributors;
- a Site Master File for wholesalers; and
- the required electronic and signed PDF versions of the application.
The PDF version of the licence application should be initialled on every page by the Authorised Representative, with the declaration section appropriately signed.
Because licensing fees can change through Government Gazette publication, applicants should verify the applicable fee before payment.
Our separate article on SAHPRA medical device licence fees deals specifically with establishment licensing costs.
How the SAHPRA application process works
The process begins by selecting the correct medical-device establishment licence application.
The applicant then completes the relevant application form and compiles the supporting documentation.
The application should reflect the same regulatory story across all documents.
The activities described in the application should align with the Quality Manual, the facility arrangements, the product listings and the responsibilities assigned to the Authorised Representative.
The product listing should be complete and the relevant classification information should be consistent with the applicable SAHPRA classification framework.
A complete submission then moves through SAHPRA’s administrative and technical screening and evaluation process.
How long does a medical device licence application take?
As at November 2023, SAHPRA indicated that the average review period for a complete business-as-usual application was approximately six to eight weeks.
That period depended on factors including application completeness and how quickly the applicant responded to observation or deficiency letters.
It should therefore be viewed as an indicative regulatory processing period rather than a guaranteed deadline.
Companies planning a product launch should also account for the time required before submission to prepare the QMS, application documentation, product listings and supporting evidence.
For a dedicated discussion of licensing timelines, see How Long Does a SAHPRA Medical Device Licence Take?
Third-party storage and outsourced activities
Many medical-device companies use third-party logistics providers or external warehouses.
This arrangement needs to be considered during licensing.
Manufacturers and distributors using third-party storage should ensure that the third-party company holds the appropriate approval where required.
Delegated activities should also be controlled through written agreements.
An applicant should therefore identify outsourced activities before submission rather than treating warehousing or distribution arrangements as something to finalise later.
What happens if SAHPRA identifies deficiencies?
SAHPRA subjects establishment licence applications to administrative and technical screening.
If information is missing or inadequate, the applicant may receive an observation letter identifying deficiencies.
As at November 2023, business-as-usual applicants were generally given 10 working days to respond to observation letters. Failure to respond could result in rejection of the application.
Common deficiencies can arise from incomplete application forms, inconsistencies between the application and Quality Manual, missing supporting documents, incomplete product listings, incorrect classification, unsigned documents or inaccurate company information.
A licence application should ideally undergo a regulatory readiness review before it is filed with SAHPRA.
Amendments, notifications and changes after licensing
Obtaining the licence does not end the establishment’s regulatory responsibilities.
Changes to the organisation or its licensed activities may need to be reported to SAHPRA.
As at November 2023, SAHPRA distinguished between amendments and notifications.
An amendment applied where a change affected information appearing on the licence or altered a substantive element of the approved establishment.
Notifications applied to certain changes that did not alter the particulars reflected on the issued licence.
Companies should therefore establish change-control procedures that consider whether a proposed organisational, facility or portfolio change has a regulatory impact.
Common establishment licensing mistakes
Several issues can complicate or delay a medical device establishment licence application.
The first is choosing a licence based on the company’s name rather than its actual activities.
The second is submitting an incomplete or generic Quality Manual that does not describe the actual establishment.
The third is appointing an Authorised Representative without ensuring that the person has sufficient regulatory knowledge, access and authority.
The fourth is submitting product classifications without adequately assessing the South African classification rules.
The fifth is overlooking third-party storage and distribution arrangements.
The sixth is failing to align the product list, QMS scope and activities stated in the application.
The seventh is assuming that foreign approvals remove the need for South African establishment licensing.
The eighth is planning commercial launch dates around the licence review period without allowing enough time to prepare a complete application.
Preparing a stronger SAHPRA licence application
Start by mapping every activity the South African entity will perform.
Determine whether those activities fall within manufacturing, distribution or wholesaling.
Confirm the facilities and third-party service providers involved.
Identify the Authorised Representative and clarify the person’s responsibilities.
Classify the medical devices and prepare the product listing.
Develop or review the Quality Management System so that it reflects the real operating model.
Compile the Quality Manual or Site Master File as applicable.
Check the required application forms and current fee before submission.
Carry out a completeness review of the entire application package.
Finally, make sure the company has a process for responding quickly to SAHPRA observations once the application is under review.
For international manufacturers, these activities should form part of the broader medical device market-entry strategy for South Africa.
Key SAHPRA references
- Medicines and Related Substances Act 101 of 1965, as amended
- Regulations Relating to Medical Devices and In Vitro Diagnostic Medical Devices
- SAHPGL-MD-06, Guideline for a Licence to Manufacture, Import, Export or Distribute Medical Devices and IVDs, Version 3
- SAHPGL-MD-07, Guideline on Questions and Answers: Licensing of Medical Device Establishments, Version 3
- SAHPGL-MD-05, Guideline on Medical Device Quality Manual
- SAHPGL-MD-04, Guideline for Classification of Medical Devices and IVDs
- SAHPRA Position Statement 9.106, Class A Medical Devices
Related Verion Medical insights
- Medical Devices and IVDs in South Africa: The Regulatory Framework Explained
- Medical Device Registration in South Africa: SAHPRA Requirements
- Medical Device Classification in South Africa: Classes A, B, C and D
- Manufacturer, Distributor or Wholesaler? Choosing the Right SAHPRA Licence
- SAHPRA Authorised Representative: Requirements and Responsibilities
- SAHPRA Medical Device Licence Fees: Costs Explained
How Verion Medical supports SAHPRA medical device establishment licensing
Verion Medical supports companies applying for or maintaining medical-device establishment licences in South Africa.
Our medical device establishment licensing services can support applicants with licence pathway assessments, manufacturer, distributor and wholesaler licence applications, regulatory readiness reviews, product-list preparation, device classification, Authorised Representative requirements and supporting regulatory documentation.
Where the licence application requires development or strengthening of the underlying quality system, Verion Medical also provides ISO 13485 and Quality Management Systems support.
Our broader services include medical device regulatory affairs, medical device registration support, technical documentation and labelling and import and export support.
For international manufacturers establishing a South African route to market, Verion Medical can help connect the establishment licence with the broader regulatory, quality and import structure required to support compliant market entry.
If your organisation is preparing a new SAHPRA medical device establishment licence application or needs to assess which licence type applies to its activities, contact Verion Medical to discuss the appropriate pathway.