Authorised Representative Requirements for SAHPRA Establishment Licences

1. Key takeaways

Applicants for a South African Medical Device Establishment Licence must appoint and designate an Authorised Representative (AR). Under the definition in Notice 1515, the AR must be a natural person resident in the Republic of South Africa, must hold the written authorisation of the manufacturer, importer, distributor, wholesaler, retailer or service provider, must act in that entity’s name on designated matters, and is responsible for the performance, quality and safety of the devices and for compliance with registration conditions, clinical trials or clinical investigations. Each premises at which business is conducted must have its own AR. The AR is therefore not an administrative convenience but a person on whom real regulatory accountability is placed, and the choice of who fills the role shapes the quality of every later interaction with SAHPRA, from licence application through registration filings to inspection responses.

2. Legal basis

3. Expert insights

Insight one: natural person is a hard restriction; a company cannot serve as the AR. The definition expressly requires a natural person resident in the Republic. This means a South African subsidiary or a distributor company cannot simply be written in as the AR; a specific individual must be designated. This differs from the European Union approach, under which the authorised representative may be a legal person, and it is a distinctive feature of the South African system — as well as the pitfall most easily stumbled into by companies from the Chinese mainland preparing their first South African submission.

Insight two: the AR’s scope of responsibility goes far beyond being a mail recipient. Paragraph (c) of the definition makes the AR responsible for every aspect of the devices, including performance, quality and safety, and compliance with registration conditions and with clinical trial or clinical investigation requirements. This is a bundle of responsibilities that overlaps heavily with those of the licence holder. When selecting an AR, companies should treat the role as a substantive position rather than a nominal affiliation, and should define the boundaries of responsibility and any indemnity arrangements clearly in the letter of appointment.

Insight three: one AR per premises directly determines staffing costs. The official requirement is one AR for each premises at which business is conducted. For companies operating multiple warehouses, multiple outlets or multiple sites, the number of ARs grows linearly with the number of premises. This must be considered upfront in budget and workforce planning rather than patched after the fact, because the licence application itself must list the premises and their ARs, and adding premises later triggers amendments.

Insight four: AR information in registration and licence applications must be consistent. Regulation 8(2) requires the registration application to state the details of the South African AR responsible for communicating with the Authority; Regulation 8(5)(a)(vii) requires the application form to include the AR’s contact details; and Regulation 8(7) requires the declaration of conformity to be made by the AR. All three point to the same natural person, and any inconsistency will be picked up at formal review and returned for correction, costing weeks on a timeline that is usually already tight.

Insight five: the AR appointment documents are a fixed item at formal review. The application form requires the AR’s curriculum vitae (CV) and a letter of appointment issued by the company, and every page of the application form must be signed by the AR at the foot, with the AR section and the declaration section fully signed. Incomplete signatures are a common reason for rejection — a detail that has no direct counterpart in submission experience from the Chinese mainland, where sign-off conventions differ, so checklist discipline matters here.

4. Practical recommendations

1. Staff ARs by premise count: map the premises first, then fix the headcount.
2. Assess the candidate’s actual capacity to perform before appointment: the AR carries substantive responsibility.
3. Define duties, term and product scope in the letter of appointment: and agree mechanisms for changes and termination.
4. Have the AR sign every page of the application form: the AR section and the declarations must be fully signed.
5. Submit the CV and the letter of appointment together: fixed annexes for formal review.
6. Keep AR information consistent across licence, registration and labelling.

5. Verification checklist

• □ Verify that the AR is a natural person resident in South Africa (not a corporate entity)
• □ Verify that ARs are staffed by premise count (one per premises)
• □ Verify that the company’s letter of appointment for the AR has been obtained (duties, term, product scope)
• □ Verify that the AR curriculum vitae (CV) has been prepared
• □ Verify that every page of the application form has been signed by the AR at the foot
• □ Verify that the AR section and the declaration section are fully signed
• □ Verify that AR information is consistent across licence, registration and labelling
• □ Verify that written arrangements with the AR on responsibility boundaries and information flows are in place

Regulatory information verified as of 29 October 2026. The instruments, guidelines and effective dates described in this article are limited to the content published by the official sources listed under the legal basis above as at that date; where official documents are updated, the latest published version prevails.

• South Africa local support: GRZAN assists manufacturers in the Chinese mainland and abroad with SAHPRA Medical Device Establishment Licence (MDEL) applications and product registration preparation, including Authorised Representative (AR) arrangements, ISO 13485 certification pathway planning and CAB selection, GMDN coding and classification decisions, technical documentation, and the setup of vigilance and adverse event reporting mechanisms.
• Service capabilities: product attribute determination and risk classification (Class A, B, C, D), establishment licence applications and renewals, reliance pathway arguments, technical documentation and essential principles conformity arguments, labelling and instructions for use localisation in English, and post-market vigilance and annual compliance submissions.
• Contact: info@grzanglobal.com; hito.lin@grzan.cn; website www.grzan.cn.