The 2017 Call-Up Notice and Transitional Licensing Arrangements

1. Key takeaways

The implementation of South Africa’s establishment licence regime was set in motion by the call-up notice published on 24 February 2017 in Government Gazette No. 40637: the notice required all manufacturers and distributors of medical devices and IVDs to lodge licence applications within 6 months of publication, and wholesalers within 12 months. During the transition period, SAHPRA permitted an acknowledgement letter to substitute for an establishment licence in order to facilitate trade; however, as of 31 March 2020, acknowledgement letters are no longer accepted as a substitute for an establishment licence. Since then, no medical device may be manufactured, distributed, imported, exported or sold in South Africa without a valid SAHPRA establishment licence. The episode remains instructive today: it shows how SAHPRA sequences obligations by category and by supply-chain position, and how transitional conveniences are withdrawn on a fixed date once the underlying regime matures.

2. Legal basis

3. Expert insights

Insight one: the six-month gap between the two subject groups reflects the regulator’s sequencing. Manufacturers and distributors had 6 months; wholesalers had 12 months. This ordering shows that the regulator tightened the product-origin end of the supply chain first and the circulation end afterwards. For companies today this timeline has fully run its course, but its lesson remains valid: when a new call-up notice is published, the order in which classes and supply-chain roles are swept in will likely follow risk and controllability, and planners can use that pattern to predict their own position in a future queue.

Insight two: the acknowledgement letter was a South African transitional instrument, and it has ended. In the early phase of the licensing regime, SAHPRA allowed companies to operate on the acknowledgement letter received after submitting an application instead of a licence, so that market supply would not be interrupted. That arrangement terminated on 31 March 2020. This history explains why some long-established companies still hold acknowledgement letters in their files — such letters today have no substitutive effect whatsoever, and relying on one in a tender or inspection will be treated as operating without a licence.

Insight three: transitional Regulations 27 and 28 address two different objects. Regulation 27 addresses unlicensed manufacturers, distributors and wholesalers (the establishment level); Regulation 28 addresses unregistered devices and IVDs (the product level). The two provisions map exactly onto South Africa’s two-track structure: the establishment transition has concluded, while the product transition has not yet begun. Reading them side by side is the clearest way to see that licensing and registration are distinct regimes on distinct clocks.

Insight four: the endpoint of the transitional arrangements was the licence, not registration. The 2017 notice resolved the question of establishment licensing and never touched product registration. It is therefore not interchangeable with the product registration call-up mechanism under Section 14 — a company cannot conclude that future registration is also satisfied merely because it completed licensing under the 2017 notice. The two tracks will each require their own dossier, their own fees and their own timelines.

Insight five: tender eligibility upgrades the licence from a legality requirement to a commercial access requirement. SAHPRA states expressly that participation in national and provincial tenders requires presentation of a valid establishment licence. The licence’s reach therefore extends beyond compliance itself into market access. For companies targeting the public health system, the time value of holding the licence far exceeds its cost, and renewal lapses during a tender window can be commercially fatal.

4. Practical recommendations

1. Confirm the company relies on no historical acknowledgement letter: that credential ceased to be valid on 2020-03-31.
2. Treat the current licence as the sole lawful trading credential: maintain a licence register with expiry reminders.
3. Plan renewals on the 5-year cycle: renewal is handled under Section 22D.
4. Secure licensing early if targeting public markets: tenders are a hard gate.
5. Separate establishment transition from product transition: never treat the licence as a substitute for registration.
6. Reserve a preparation window for future product call-ups: take the 2017 sequencing as the reference.

5. Verification checklist

• □ Verify the two deadlines of the 2017-02-24 notice (6 months / 12 months)
• □ Verify that acknowledgement letters are no longer accepted as licence substitutes as of 2020-03-31
• □ Verify that an establishment licence register with expiry reminders is maintained
• □ Verify that renewal is planned on the 5-year cycle (Section 22D)
• □ Verify that Regulation 27 (establishment transition) and Regulation 28 (product transition) are distinguished
• □ Verify that the licence is documented as not a substitute for product registration
• □ Verify that the establishment licence is confirmed as a hard gate for public tenders
• □ Verify that a preparation window is reserved for future product call-up notices

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.