Radiation Control Licence for Medical Devices in South Africa: Dual Licensing Explained

1. Key takeaways

In South Africa, medical devices that emit radiation (such as X-ray equipment, MRI systems and ultrasound devices with specific output levels) require, in addition to the medical device establishment licence, a Radiation Control Licence. The legal basis is the Hazardous Substances Act, 1973 (Act No. 15 of 1973) and the Regulations for Group III and IV Hazardous Substances: Electronic Products, R1302 of 1991 made under it; moreover, the device definition in Act No. 101 of 1965 itself covers Group III and Group IV Hazardous Substances as defined in the Hazardous Substances Act. The Radiation Control function has been merged into SAHPRA, so both licences can be initiated through a single submission but are still issued separately.

2. Legal basis

3. Expert insights

Insight 1: The overlap between the device definition and the Hazardous Substances Act is the root of dual licensing. The device definition in Act No. 101 of 1965 explicitly includes Group III and Group IV Hazardous Substances under the Hazardous Substances Act, and these groups correspond to radioactive and certain other hazardous articles. This means that radiation-emitting equipment falls within two legal regimes at the level of definition itself, rather than through a requirement that was added later, so dual licensing is structural and will not disappear as the framework matures.

Insight 2: One submission, two certificates is the practical shape after SAHPRA’s integration. Since the Radiation Control function was merged into SAHPRA, the establishment licence and the Radiation Control Licence can be initiated through a single submission, but they remain two independent permits. Companies cannot schedule the work as if it were one certificate, nor assume that the two approvals will arrive simultaneously — timelines should be planned for each permit separately, with internal dependencies mapped.

Insight 3: The validity structure of the Radiation Control Licence differs from that of the establishment licence. The establishment licence is valid for five years and requires annual retention fee payments; the Radiation Control Licence is generally valid indefinitely but requires an annual written confirmation (practical estimate: common industry observation is that the confirmation, confirming that CE certificates remain valid, is submitted each September). The two permits run on different maintenance rhythms, so the licence registers must be managed separately.

Insight 4: R1302 of 1991 is a product-level technical gate. The regulation imposes requirements on controlled electronic products. Practical estimate: radiation-emitting equipment destined for South Africa should be checked against the applicable provisions of R1302 at the design-freeze stage, so that structural rework after the finished machine is complete can be avoided and certification planning can absorb the requirements early.

Insight 5: The reliance pathway can reduce but not eliminate local radiation control requirements. The reliance provisions of SAHPGL-MD-22 apply to several stages including the establishment licence, but radiation safety involves the local use environment and operator qualifications and cannot rest entirely on foreign conclusions. Practical estimate: overseas radiation safety certifications can serve as supporting evidence, but the South African Radiation Control Licence must still be obtained separately for the local installation.

4. Practical recommendations

1. Schedule radiation-emitting products on a dual-licence basis: establishment licence plus Radiation Control Licence.
2. Manage the two registers separately: validity periods and maintenance rhythms differ.
3. Check the applicable provisions of R1302 of 1991 at the design stage.
4. Use SAHPRA’s internal integration: initiate both applications through one submission.
5. Set a separate reminder for the annual confirmation obligation of the Radiation Control Licence (practical estimate).
6. Treat overseas radiation safety certification as support, not substitution.

5. Verification checklist

• □ Determined whether the product emits radiation (X-ray, MRI, specific ultrasound, and similar)
• □ Confirmed that a Radiation Control Licence is required in addition to the establishment licence
• □ Applicability of Group III/IV Hazardous Substances under the Hazardous Substances Act checked
• □ Applicable provisions of Regulation R1302 of 1991 on controlled electronic products checked
• □ Registers for the two permits managed separately (validity and maintenance rhythms differ)
• □ SAHPRA’s internal integration used to initiate both applications through one submission
• □ Reminder set for the annual confirmation obligation of the Radiation Control Licence (practical estimate)
• □ Overseas radiation safety certifications prepared as supporting material (not a substitute for the local 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.