SAHPRA Authorised Representative: Requirements & Duties

Every medical device establishment applying for a SAHPRA manufacturer, distributor or wholesaler licence needs to understand the role of the Authorised Representative.

The role is considerably more important than simply providing a name and signature on the establishment licence application.

Under South Africa’s Regulations Relating to Medical Devices and In Vitro Diagnostic Medical Devices, an Authorised Representative is a natural person resident in South Africa who has a written mandate to represent a manufacturer, importer, distributor, wholesaler, retailer or service provider.

The regulatory definition also places responsibility on that person for aspects of the medical device or IVD including performance, quality, safety and regulatory compliance.

For companies entering the South African market, the appointment should therefore be treated as a regulatory governance decision rather than an administrative formality.

What is a SAHPRA Authorised Representative?

The South African regulatory definition is specific.

An Authorised Representative is a natural person resident in the Republic of South Africa who has a written mandate to represent a manufacturer, importer, distributor, wholesaler, retailer or service provider and acts on behalf of that organisation for specified regulatory obligations.

The role also carries responsibilities relating to medical device or IVD performance, quality, safety and applicable regulatory compliance.

Three elements are therefore fundamental:

the representative must be an individual;
the person must be resident in South Africa; and
the appointment must be supported by a written mandate.

The role is connected directly to the regulated establishment and its medical device obligations.

For the wider establishment licensing framework, see SAHPRA Medical Device Establishment Licence: Complete Guide.

Does every medical device establishment need one?

The Authorised Representative forms part of the SAHPRA medical device establishment licensing structure.

Manufacturers, distributors and wholesalers applying for establishment licences identify an Authorised Representative and submit supporting information relating to that individual.

The person’s curriculum vitae forms part of the standard licence application package and the representative signs the relevant regulatory documentation.

The practical responsibilities will differ according to whether the establishment operates as a manufacturer, distributor or wholesaler.

Must the Authorised Representative live in South Africa?

Yes.

The regulatory definition specifies a natural person resident in South Africa.

A person permanently based outside South Africa should therefore not be treated as satisfying the local residency requirement merely because that person works within the foreign manufacturer’s global regulatory affairs function.

Foreign manufacturers should address the locally resident Authorised Representative requirement when establishing their South African regulatory structure.

See How Foreign Medical Device and IVD Manufacturers Can Enter the South African Market.

Can a company be the Authorised Representative?

No, not in the sense contemplated by the SAHPRA medical device definition.

The Authorised Representative is defined as a natural person.

A regulatory consultancy, distributor or other organisation may support the regulatory function, but an appropriate individual needs to be identified where the SAHPRA Authorised Representative role is concerned.

This distinction can be important for international manufacturers accustomed to regulatory systems where a legal entity itself may act as an authorised representative.

What does the written mandate mean?

The Authorised Representative must have a written mandate to represent the relevant establishment.

The mandate should define the regulatory authority and responsibilities assigned to the individual.

Depending on the organisation, this may include responsibilities relating to licensing, regulatory correspondence, product information, quality-system processes, regulatory declarations, complaints, safety matters and regulatory changes.

The person should have sufficient authority and access to information to perform those responsibilities effectively.

What is the Authorised Representative responsible for?

SAHPRA’s regulatory definition places performance, quality, safety and regulatory compliance within the Authorised Representative’s responsibilities.

This does not mean that the individual personally performs every quality, technical or regulatory task.

The establishment may have quality personnel, regulatory specialists, warehouse teams and management performing different functions.

The Authorised Representative should nevertheless have sufficient regulatory oversight to understand whether the establishment is operating in accordance with its licence and applicable requirements.

The Authorised Representative and the SAHPRA licence application

The Authorised Representative plays a direct role in the establishment licence submission.

A standard business-as-usual application includes:

a cover letter signed and dated by the Authorised Representative;
the relevant licence application;
proof of payment;
the Authorised Representative’s curriculum vitae;
a Quality Manual for manufacturers or distributors, or Site Master File for wholesalers;
the editable application file; and
a PDF application initialled on every page by the Authorised Representative.

The declaration section of the application is also signed by the Authorised Representative.

The person should therefore understand the regulatory submission before signing it.

Why SAHPRA requires the Authorised Representative’s CV

The curriculum vitae of the Authorised Representative forms part of the establishment licence application.

The CV should be current and accurately describe the individual’s professional background and relevant experience.

Relevant experience may include medical devices, regulatory affairs, quality management, manufacturing, distribution, healthcare products or other activities appropriate to the establishment.

The suitability of the person should be considered against the actual scope and complexity of the organisation.

Does SAHPRA prescribe a specific professional qualification?

SAHPRA’s general establishment licensing guidance as at January 2024 requires the Authorised Representative’s curriculum vitae but does not prescribe one universal professional qualification for every medical device establishment.

Companies should therefore not automatically assume that the representative must always be a pharmacist, medical doctor, engineer or another specific profession.

Competence nevertheless remains important because the role carries responsibilities relating to device performance, quality, safety and regulatory compliance.

The individual should therefore have appropriate knowledge, experience, organisational authority and access to information for the activities being overseen.

The Authorised Representative and the Quality Management System

The Authorised Representative should be integrated into the establishment’s quality and regulatory processes.

Depending on the organisation, the role may interface with regulatory compliance, document control, supplier controls, product changes, importation, storage, distribution, complaints, recalls, training and management escalation.

The organisation’s Quality Manual or Site Master File should not describe a regulatory structure that is disconnected from the individual named as Authorised Representative.

For wider quality-system requirements, see ISO 13485 in South Africa: Requirements for Medical Device Companies.

Responsibilities for product quality and safety

The regulatory definition expressly includes product quality, safety and performance within the Authorised Representative’s responsibilities.

The person therefore needs appropriate access to information such as product changes, complaints, safety notices, corrective actions, recalls, manufacturer documentation and relevant regulatory information.

For distributors dealing with foreign manufacturers, the commercial and quality agreements should support the flow of this information into the South African establishment.

Complaints, vigilance and recalls

The Authorised Representative should understand how the establishment handles product complaints, safety issues and recalls.

The precise operational tasks may be allocated to different qualified personnel, but regulatory escalation routes should be clear.

Where an overseas manufacturer performs the technical investigation, the South African establishment should still have a process for obtaining the necessary information and responding appropriately to local regulatory obligations.

Product listings and regulatory changes

Changes to a medical device establishment’s information or product portfolio can create regulatory obligations.

SAHPRA’s licensing guidance requires notifications relating to applicable product-list changes to include a written declaration signed by the Authorised Representative.

The representative should therefore have visibility into new products, discontinued products, product-class changes and other regulatory changes affecting the establishment.

Commercial product additions should be subject to regulatory review before supply begins.

Can one person represent more than one company?

SAHPRA’s November 2023 licensing FAQ permits an individual to act as Authorised Representative for more than one company only within specified circumstances.

The guidance refers to representation of companies within the same address or province and situations where regulatory oversight is located at head office.

Companies should therefore not assume that one individual can automatically act as Authorised Representative for unlimited unrelated establishments.

The proposed regulatory structure should be assessed against SAHPRA’s stated conditions.

Can the Authorised Representative be outsourced?

The SAHPRA framework defines the role according to the individual’s residency, written mandate and regulatory responsibilities rather than simply describing an outsourced consulting service.

The November 2023 guidance also limits the circumstances in which one person may represent multiple companies.

Where an external individual is being considered, the organisation should therefore assess whether the arrangement satisfies SAHPRA requirements and gives the person adequate access, authority and integration into the establishment’s regulatory processes.

External regulatory consulting and the formal Authorised Representative role should not automatically be treated as the same thing.

What happens if the Authorised Representative resigns?

A change in Authorised Representative affects the establishment licence.

SAHPRA’s November 2023 guidance states that where the Authorised Representative or licence contact holder resigns, the company must follow the licence amendment process.

Companies should therefore maintain succession arrangements and ensure that regulatory records and knowledge are not controlled by one individual alone.

A replacement should be able to access licence records, product information, regulatory correspondence and outstanding compliance matters.

Authorised Representative versus licence holder

The licence holder and Authorised Representative are different concepts.

The licence holder is the regulated establishment operating under the SAHPRA establishment licence.

The Authorised Representative is the natural person appointed to act within that regulatory structure for specified obligations.

Appointment of an Authorised Representative does not remove the organisation’s responsibility to maintain appropriate resources, systems and regulatory controls.

Authorised Representative versus foreign manufacturer’s local representative

International manufacturers should avoid assuming that South Africa uses exactly the same authorised representative model as every other regulatory jurisdiction.

The SAHPRA Authorised Representative role is closely connected to the South African medical device establishment licensing framework.

Simply appointing an individual in South Africa does not, by itself, replace the need for the establishment licence required for activities such as manufacturing, importation, distribution or wholesaling.

The local representative structure and establishment licensing structure should therefore be designed together.

What international manufacturers should consider

International manufacturers should determine which South African entity will hold the establishment licence and who will act as the Authorised Representative.

The manufacturer should also establish how technical documentation, product changes, complaints, safety information, recalls and regulatory correspondence will be communicated to the South African establishment.

The arrangement should be established before commercial launch rather than after the first regulatory issue occurs.

See Manufacturer, Distributor or Wholesaler? Choosing the Right SAHPRA Licence.

Common Authorised Representative mistakes

Common mistakes include treating the role as a signature function, appointing a person who is not resident in South Africa, naming a company rather than a natural person and failing to establish a clear written mandate.

Other weaknesses include inadequate access to regulatory documentation, excluding the role from the QMS, weak safety escalation processes, failing to assess SAHPRA’s restrictions on representation of multiple companies and failing to amend the licence when the Authorised Representative changes.

The role should have sufficient authority, information and organisational support to function effectively.

How to establish an effective Authorised Representative arrangement

Start by identifying the establishment’s regulated activities and licence category.

Select an appropriate natural person resident in South Africa.

Prepare a written mandate defining the person’s regulatory responsibilities and authority.

Reflect the role consistently in the licence application, Quality Manual or Site Master File, regulatory procedures and organisational responsibilities.

Ensure the individual has appropriate access to device information, manufacturer documentation and regulatory records.

Establish communication processes for product changes, complaints, safety matters, recalls and SAHPRA correspondence.

Finally, maintain appropriate succession and handover arrangements in case the representative changes.

Key regulatory references

How Verion Medical supports Authorised Representative and licensing requirements

Verion Medical supports medical device and IVD companies in structuring the regulatory responsibilities required for South African establishment licensing.

Our SAHPRA medical device establishment licensing services can support assessment of Authorised Representative requirements, licence pathway selection, application preparation, supporting documentation, product-list preparation, amendments and regulatory readiness.

Where the Authorised Representative role needs to be integrated into the organisation’s quality system, Verion Medical also provides ISO 13485 and Quality Management Systems support, including Quality Manuals, procedures and regulatory responsibility structures.

Our broader services include medical device regulatory affairs, device classification and medical device registration support.

For international manufacturers, we can also support assessment of the South African regulatory structure so that local licensing, distribution responsibilities and regulatory oversight are aligned before market entry.

If your organisation is applying for a SAHPRA medical device establishment licence or needs to clarify the Authorised Representative structure, contact Verion Medical for a regulatory assessment.