Annual Retention Fee for South African Medical Device Establishment Licences: Deadlines and Risks

1. Key takeaways

Holders of a South African medical device establishment licence must pay an annual retention fee (Annual Retention Fee) every year, with the payment deadline falling before the last working day of June in each year. SAHPRA states explicitly that failure to pay the retention fee may lead to cancellation of the licence. Two further points are critical: first, SAHPRA does not send payment reminders; second, the retention fee remains payable even in the renewal year, because the Medicines Act does not allow a renewal exemption. This is the post-licence obligation in South Africa under which a licence is most easily lost through simple oversight.

2. Legal basis

3. Expert insights

Insight 1: By sending no reminders, SAHPRA transfers the entire risk to the licence holder. SAHPRA states explicitly that it does not issue reminders for retention fees. This means that relying on receiving a notice is an unreliable way to manage the payment obligation. Companies must build their own reminder mechanism, and it should be triggered well before June so that processing time is reserved, rather than waiting until the final working day of the month when banks, approvers and internal sign-off chains can all fail at once.

Insight 2: The consequence of cancellation is extremely severe. Without a valid establishment licence, no entity may manufacture, distribute, import, export or sell medical devices in South Africa. The direct effect of a single missed payment is an interruption of the entitlement to operate, and the knock-on effects include ineligibility for tenders, inability to process amendments and renewals, and the invalidation of the licensed product list. The cost of recovery far exceeds the R4 200 that was never paid.

Insight 3: The timing of the first payment depends on the month in which the licence was issued. Official examples: if the licence is issued in May 2020, the fee is payable in June 2021; if issued in December 2020, it is still payable in June 2021; if issued in January 2021, it is payable in June 2022. The rule can be summarised as follows: no payment in the year of issue, and payment every June from the following year onwards (practical estimate; the individual determination rests with SAHPRA).

Insight 4: Payment in the renewal year is not exempted. In its fee review documentation, SAHPRA states clearly that because the Medicines Act does not allow a renewal exemption, the retention fee still applies in the year in which the renewal is processed. This breaks the intuitive assumption that no annual fee is due in a renewal year, and it is one of the most common errors in budget calculations for the five-year cycle.

Insight 5: The retention fee is linked to ISO 13485 verification scenarios. From Phase 3 (starting 1 April 2026) onwards, SAHPRA may retrieve ISO 13485 certificates in the course of information updates, application reviews, investigations and post-market vigilance activities. Payment status and certificate status together form the licence holder’s file with SAHPRA, and any anomaly in one will surface whenever the other is retrieved, so both must be kept clean simultaneously.

4. Practical recommendations

1. Build an internal reminder mechanism: start in May and complete payment in June each year, without relying on any SAHPRA notification.
2. Confirm the first payment year according to the licence issue month: avoid missing the very first payment.
3. Include the retention fee in the renewal year as well: budget five payments across the five-year cycle.
4. Archive payment records together with the licence number: this simplifies later verification.
5. Check every site and every licensed entity one by one: no group company should be left out.
6. Report payment status in the monthly compliance report: keep management informed.

5. Verification checklist

• □ Internal calendar reminder set for starting in May and completing in June every year
• □ First payment year confirmed against the licence issue month
• □ Retention fee in the renewal year confirmed as still payable
• □ Payment amount re-checked against the current fee schedule (R4 200 per year, industry reference value)
• □ Payment records archived together with the licence number
• □ Every licensed entity within the group checked with no omissions
• □ Payment status included in the monthly compliance report
• □ Awareness confirmed that non-payment may lead to cancellation of the licence

Regulatory information verified as at 29 October 2026. The regulations, guidance and effective dates described in this article are limited to the content published by the official sources listed under Legal basis as at that date; where official documents have been updated, the latest published version prevails.

• South Africa local resource: GRZAN can assist manufacturers from the Chinese mainland and overseas in engaging the South African Health Products Regulatory Authority (SAHPRA) on medical device establishment licence (MDEL) applications and product registration preparation, including authorised representative (AR) scheme design, ISO 13485 certification route planning and CAB selection, GMDN coding and classification determination, technical documentation preparation, and the establishment of vigilance and adverse event reporting mechanisms.
• Service capabilities: product attribute determination and risk classification (Class A/B/C/D), establishment licence application and renewal, reliance pathway justification, technical documentation and essential principles conformity argumentation, labelling and instructions-for-use localisation in English, and post-market vigilance and annual compliance information submission support.
• Contact: hito.lin@grzan.cn; website www.grzan.cn.