PPB Guideline HPT/PER/HTR/GUD/011 Rev.02: Scope, Effect and Fees

Content verification date: October 30, 2026

1. Key takeaways

• The core operational document for medical device registration in Kenya is the PPB Guidelines for Registration of Medical Devices including In-Vitro Diagnostics, numbered HPT/PER/HTR/GUD/011, version Rev.02, issued in January 2022, effective January 31, 2022, with a review date of January 1, 2027.
• At the end of Section 1.1 the guideline sets its own effect clause: where the guideline conflicts with any written law, the written law prevails. This provision determines the order of argument when a company faces inconsistency between the guideline and the law.
• The scope of application (Section 1.3) has three boundaries: it applies to medical devices and their accessories; devices used to administer medicinal products remain governed by this guideline without prejudice to the medicinal product registration rules; and where a device contains, as an integral component, a substance that on its own may be considered a medicinal product and that acts on the human body in an ancillary manner, the device is to be evaluated and approved under this guideline.
• The guideline does not stand alone. It is accompanied by the Guidelines for Registration of Medical Devices Establishments (PRA/LPP/GUD/072), the Fast Track Review guideline (HPT/PER/GUD/041) and the Suspension and Revocation guideline (HPT/PER/GUD/042).
• The version history is clear: Rev.000 (PPB/PER/MDV/GDL/003, August 2017) → Rev.001 (PPB/PER/MDV/GDL/005, August 2021) → Rev.002 (HPT/PER/HTR/GUD/011, January 2022).

2. Legal basis

3. Expert insights

Insight 1: The written-law-prevails clause is a defence tool in the hands of companies

Section 1.1 of the guideline is blunt: where there is a contradiction between the guideline document and any written law, the latter shall prevail. GRZAN’s reading: this is a favourable clause for companies. The PPB guideline contains extensive operational positions (document lists, route conditions, fee tables), some of which do not appear in Cap. 244 or LN 100 of 2022. When a reviewer raises requirements beyond the written law on the basis of the guideline, companies may cite this clause and request written explanation. In practice, the more robust approach is still to prepare to the guideline standard and argue on the legal standard — leave no gap at the preparation stage, and keep room for reasoned argument if a dispute arises.

Insight 2: Real gaps exist between the guideline and the law; both tracks must be recorded

Fees are the clearest example. The Second Schedule of LN 100 of 2022 lists only four USD tiers for device registration and renewal (USD 100 / 200 / 1,000 / 1,000), while the guideline’s Table 6 additionally distinguishes imported and locally manufactured products and adds a variation fee of USD 200 and annual retention fees (A&B USD 50, C&D USD 300). The two do not contradict each other, but their coverage differs. GRZAN recommends keeping both tables on file for budgeting and submission, with the invoice actually generated by the PRIMS system as the final authority.

Insight 3: Sections 1.3(b) and (c) pull drug-device combinations back onto the device track

Section 1.3(b) provides that devices used to administer medicinal products are governed by this guideline without prejudice to the corresponding registration rules for human and veterinary medicinal products. Section 1.3(c) provides that where a device contains, as an integral component, a substance that on its own may be considered a medicinal product and that acts on the human body in an ancillary manner, the device must be evaluated and approved under this guideline. GRZAN’s reading: Kenya adopts a device-track-first approach with drug rules running in parallel, rather than pushing all combination products to the drug department. This anticipates the Primary Mode of Action (PMOA) determination developed in article 06 — first fix the track, then fix the reviewing department.

Insight 4: The guideline itself is awaiting review; companies should anticipate the revision window

The guideline states a review date of January 1, 2027, and PPB is working toward WHO maturity level 3 and preparing for the WHO global benchmarking tool assessment in September 2026 (public statements — practical estimate). GRZAN’s judgment: the probability of revision around the review milestone is high, and the direction will likely tighten technical documentation requirements and align further with IMDRF. CSDT prepared today should target a higher completeness tier than the current guideline demands, to reduce rework after revision.

4. Practical recommendations

1. Write the effect clause into internal appeal templates. Where review requirements exceed the written law, cite Section 1.1 and request written explanation, while still supplying what the guideline asks for.
2. File both fee tables. Keep the Second Schedule and guideline Table 6 side by side, with the PRIMS invoice as the final authority.
3. Add the companion guidelines to the reading list. Alongside the main guideline, consult PRA/LPP/GUD/072, HPT/PER/GUD/041 and HPT/PER/GUD/042 at the corresponding project stages.
4. Write the CSDT one tier above current requirements. Anticipate the tightening driven by the January 1, 2027 review milestone and the WHO ML3 effort.
5. Keep version traceability. State the guideline number and version relied upon (HPT/PER/HTR/GUD/011 Rev.02) in submission documents, so differences can be traced when versions change.
6. Check companion legislation in step. Section 1.1 of the guideline notes that the supply and use of devices must also comply with other applicable legislation (such as the Nuclear Regulatory Act); verify these in parallel at project kickoff.

5. Verification checklist

• □ Have the number and version of the guideline relied upon been recorded (HPT/PER/HTR/GUD/011 Rev.02)?
• □ Have the effective date of January 31, 2022 and the review date of January 1, 2027 been checked?
• □ Has the product been confirmed to fall within the scope of Section 1.3?
• □ Have the three companion guidelines been consulted (PRA/LPP/GUD/072, HPT/PER/GUD/041, HPT/PER/GUD/042)?
• □ Have fee calculations been checked against both the Second Schedule and guideline Table 6?
• □ Is a monitoring and comparison mechanism in place for guideline version changes?
• □ For drug-containing or combination products, has the track determination been completed first?
• □ Have parallel obligations under other applicable legislation (radiation, data protection, standards) been checked?

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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For a Kenya market access plan tailored to your product, contact the GRZAN regulatory team at info@grzanglobal.com.