Radiological Devices in Kenya: KNRA Authorization under the Nuclear Regulatory Act

Content verification date: October 30, 2026

1. Key takeaways

• Kenya’s current law on radiation regulation is the Nuclear Regulatory Act, No. 29 of 2019, now codified as Cap. 243; it was assented December 23, 2019 and effective January 10, 2020, published in the Kenya Gazette Vol. CXXII—No. 4 (January 10, 2020).
• The Act repealed the former Radiation Protection Act (former Cap. 243; assented December 29, 1982, effective November 1, 1984) and established, under Section 5, the Kenya Nuclear Regulatory Authority (KNRA), which took over the functions of the former Radiation Protection Board and expanded the scope of regulation.
• The definition of activity expressly includes the production, use, import and export of radiation sources for industrial, research and medical purposes; authorization includes licences, permits, registration and approvals among its forms.
• Both the sale and installation of radiation sources and the import and export of radiation sources are activities requiring KNRA authorization.
• PPB guideline Section 1.1 expressly notes that even where a device is registered under the Pharmacy and Poisons Act, its supply and use remain subject to other applicable legislation, including the Nuclear Regulatory Act.

2. Legal basis

3. Expert insights

Insight 1: Radiation devices are the classic two-keys-one-lock case

CT scanners, X-ray machines, radiotherapy equipment and catheters containing sealed radioactive isotopes require two sets of authorization in parallel in Kenya: device registration under PPB (under Cap. 244 and LN 100 of 2022) and radiation authorization under KNRA (under the Nuclear Regulatory Act, No. 29 of 2019). GRZAN’s note: the two authorizations examine different objects — PPB looks at the safety, effectiveness and performance of the device, while KNRA looks at the use of radiation sources, premises, personnel and protection. Missing either one leaves the equipment unable to be lawfully installed and used.

Insight 2: Authorization is a collective concept, and companies often apply for only one of its forms

Section 2 of the Nuclear Regulatory Act defines authorization as the granting of a written permission to perform specific activities, including a licence, permit, registration and approval. GRZAN’s reading: this is a collective definition, meaning different activities correspond to different forms of authorization document. Selling and installing radiation sources, importing and exporting them, and using them are different activities; an authorization obtained for equipment import does not cover installation and after-sales service. In practice, companies should verify the required authorization form activity by activity against an activity list.

Insight 3: PPB’s classification rules have already internalized radiation risk

Table 1 of Section 2.1 of the guideline lists catheters containing sealed radioactive isotopes as a Class C (medium-to-high risk) example. GRZAN’s judgment: PPB has already taken radiation risk into account in device classification, but its classification conclusion cannot substitute for the independent KNRA authorization of the radiation source. Companies should proactively disclose radiation-related designs in their submissions, keeping information consistent across the PPB and KNRA sides.

Insight 4: The change of law creates transition risk

The Nuclear Regulatory Act became effective on January 10, 2020 and repealed the former Radiation Protection Act, with KNRA taking over from the Radiation Protection Board and expanding the scope of regulation. GRZAN’s note: radiation-related documents obtained under the old law before January 10, 2020 should have their validity and succession verified case by case; premises licences and personnel qualifications for long-installed equipment are particularly easy to miss during an institutional change.

4. Practical recommendations

1. Check authorization forms against an activity list. List import, sale, installation, use, maintenance and decommissioning item by item, and confirm the corresponding KNRA authorization form (licence / permit / registration / approval) for each.
2. Schedule PPB and KNRA in parallel. Start both approval lines together so the certificate does not get stuck on radiation authorization.
3. Disclose radiation design proactively in submissions. State the radiation type and protection design in the PPB dossier, keeping it consistent with what is filed with KNRA.
4. Verify the validity of legacy documents. Radiation-related documents obtained before January 10, 2020 should be checked case by case for succession arrangements.
5. Keep installation and after-sales authorizations separate. Do not let an import authorization cover installation and maintenance activities.
6. Appoint a cross-department compliance owner. Assign one person to track expiry and change milestones on both the PPB and KNRA sides.

5. Verification checklist

• □ Has a complete list of radiation-related activities been drawn up (import, sale, installation, use, maintenance, decommissioning)?
• □ Has the KNRA authorization form been confirmed activity by activity?
• □ Have PPB registration and KNRA authorization been scheduled in parallel?
• □ Does the PPB submission proactively disclose radiation design, consistent with other filings?
• □ Have radiation documents obtained before January 10, 2020 been verified case by case?
• □ Have installation and after-sales activities obtained separate authorization?
• □ Has a cross-department compliance owner been appointed to track expiry milestones on both sides?
• □ Has the device’s PPB risk class been confirmed (for example, Class C for catheters containing sealed radioactive isotopes)?

Regulatory information verified as of October 30, 2026.

In African markets, the GRZAN regulatory team focuses on jurisdictions including Kenya, Nigeria, South Africa and Egypt and maintains a verification mechanism built on primary regulatory sources: every regulatory conclusion published externally is based solely on official gazettes, the original text of agency guidelines and public legal databases, with the verification date stated; figures, timelines and amounts that cannot be located in official sources are marked as practical estimates, with no assumptions made.

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