Personal Use Import of Medical Devices: SAHPRA MD11-2025/26 Requirements

1. Key takeaways

On 25 March 2026 SAHPRA published the communication Application for the Importation of Medical Devices for Personal Use (MD11-2025/26), regulating applications to import medical devices for personal use. The communication addresses the specific scenario of personal use, which sits on a separate track from commercial importation — commercial importation still requires a valid establishment licence as its precondition (Regulation 3; Act No. 101 of 1965, Section 22C(1)(b)). Companies must not use the personal-use track for any commercial supply arrangement.

2. Legal basis

3. Expert insights

Insight 1: South Africa dedicates a separate communication to personal use, showing that this scenario reflects a genuine institutional need. Such tracks typically serve patients bringing devices into the country, personally carried home-use devices, or cross-border treatment scenarios. The institutional value lies in ensuring that patients are not left unable to obtain necessary devices merely because no commercial entity is involved — the track runs in parallel with commercial importation, not as a substitute for it, and neither can absorb the other’s obligations. Typical scenarios include a replacement pump for a patient’s home therapy, a device carried while travelling for treatment, and consumables needed by a single patient.

Insight 2: Compared with the value-threshold exemption applied elsewhere, South Africa operates an application-based system rather than a monetary exemption. Some jurisdictions exempt low-value Class I and IIa devices imported for personal use up to a fixed monetary ceiling as a statutory exemption; South Africa instead regulates how to apply through a SAHPRA communication. What the approaches share is that both are confined to personal use and neither applies to commercial distribution, so the existence of a personal-use route never relaxes the commercial pathway’s requirements. The practical consequence is that each personal-use import requires an individual application assessed on its own facts, which is precisely what makes the track unsuitable for volume supply.

Insight 3: The threshold for commercial importation is not lowered by this communication. Commercial importation still requires a valid establishment licence that includes import authorisation, processed under Regulation 3. Any arrangement that imports in batches under the label of personal use and then diverts the goods into commercial sale circumvents the licensing system, and its risk level is far higher than that of a normal application, since it combines unlawful importation with unlawful distribution. The pattern is also easily detected: repeated consignments of the same product to different end users do not resemble personal use.

Insight 4: The authorised representative requirement does not apply on the personal-use track but is mandatory on the commercial track. Personal-use applications are submitted by individuals; a commercial importer, by contrast, must appoint a natural person residing in South Africa as its authorised representative, with one representative per premises. This difference is a practical yardstick for judging which track a given import belongs to, and it also explains why commercial importers cannot piggyback on the lighter personal-use procedure. A distributor approached by an end user should therefore redirect the enquiry to its licensed import channel rather than coach the customer into a personal application.

Insight 5: Devices imported for personal use remain subject to safety requirements. Even on the personal-use track, the device itself must comply with the device requirements under Act No. 101 of 1965. Practical estimate: for devices involving radiation emission, implantability or high-risk classes, the personal-use track may not be available at all, and availability should be confirmed with SAHPRA before any application is lodged. Supporting documents such as a prescription or a clinical motivation, where the communication allows them, will strengthen the application.

4. Practical recommendations

1. Strictly separate personal use from commercial importation: never mix the two tracks.
2. Prepare personal-use application materials under MD11-2025/26: the current version of the communication prevails.
3. Route all commercial supply through the establishment licence pathway: never evade it through batched personal-use imports.
4. Confirm applicability for high-risk categories before applying: radiation, implants, Class C/D.
5. Retain application and approval records: available for any later verification.
6. Explain the difference between the two tracks to customs brokers: avoid declaration errors.

5. Verification checklist

• □ Current text of MD11-2025/26 (2026-03-25) obtained
• □ Import determined as personal use or commercial use
• □ Valid establishment licence including import authorisation confirmed for commercial importation
• □ Personal-use applications not used for any commercial supply arrangement
• □ Applicability of high-risk categories confirmed with SAHPRA in advance (practical estimate)
• □ Application and approval records retained
• □ Customs brokers briefed on the difference between the two tracks
• □ Confirmed that the personal-use track does not replace authorised representative obligations (commercial scenarios)

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.