Kenya CSDT Dossier Format: Modules, Classes and Evidence Requirements

Content verified as of 30 October 2026.

1. Key takeaways

• Kenya does not accept free-format technical documentation. Whether the route is a Class A listing or a Class B/C/D registration, the dossier must be organised under the Common Submission Dossier Template (CSDT); the template itself is one of the thresholds for acceptance.
• The CSDT embeds the Summary Technical Documentation (STED) elements of the International Medical Device Regulators Forum (IMDRF), which aligns the structure of a Kenya submission directly with the internationally accepted structure.
• The full CSDT comprises 20 modules, covering administrative information, device identification and classification rationale, 5 years of sales, complaint and vigilance data, a draft declaration of conformity, an Essential Principles checklist, design verification and validation, risk management, clinical evaluation, post-market surveillance and post-market clinical follow-up, biological safety, sterilization validation, software, packaging, and shelf life and stability.
• The number of dossier items is tiered by class: 9 items for a Class A listing and 12 items for Class B/C/D (Table 5 of the guidelines). The two tiers are not a simplified-versus-full containment relationship; the logic for missing items differs entirely.
• Complete modules do not mean sufficient evidence. In project work, GRZAN has observed that most rejections arise from broken chains of evidence inside modules, not from one missing module.

2. Legal basis

3. Expert insights

Insight 1: The CSDT is the container, the STED is the measure. The division of labour between the two determines how much translation work a company must do. The CSDT fixes module order, numbering and how attachments are mounted; the STED fixes the level of detail expected inside each module. The reason Kenya applies the IMDRF structure directly lies in Section 3B(2)(r) of the Pharmacy and Poisons Act (Cap. 244): PPB is empowered to recognise and rely on decisions of reference regulatory authorities (RRAs) and notified bodies. The reliance route only works if the dossier structure is readable to the other side; otherwise reviewers cannot map CE or FDA conclusions onto domestic requirements. The common pitfall is uploading a wholesale translation of the overseas technical file without rearranging it into CSDT modules, so that no cross-reference exists between the design verification and validation module and the clinical evaluation module, and the reviewer can only return the whole dossier.

Insight 2: Five years of sales, complaint and vigilance data is not an annex. The CSDT treats this as a stand-alone module, and its practical value goes far beyond historical record. It links directly to route eligibility: the expedited EBR route for Class B requires no global safety issues over the past 3 years — no death reports, no reports of serious deterioration in health, and no open field safety corrective actions (FSCAs) at the time of submission; the IBR route likewise requires no safety issues over the past 3 years. Every recall and every complaint recorded in this module is therefore also read as reverse evidence of route eligibility. The GRZAN approach is to clean and characterise the data before submission rather than export a raw complaint ledger.

Insight 3: The divide between 9 and 12 items lies in internal evidence, not in numbers. Within the 9 Class A items, a large share are external credentials: the PVoC pre-export verification certificate or certificate of conformity (CoC), the certificate of analysis (CoA), regulatory approval in the country of origin, and QMS evidence. The 12 Class B/C/D items shift toward internal evidence: detailed design verification and validation, complete preclinical study reports, and clinical evidence. The two logics differ: lower-risk devices are endorsed by external credentials, while medium- and higher-risk devices must persuade through their own evidence chain. Applying Class A thinking to a Class C product, or Class C report volume to Class A, produces unnecessary deficiency letters.

4. Practical recommendations

1. Produce a module mapping table first. GRZAN recommends building a source-document-to-CSDT-module table at project start, marking each item as reusable, rewrite-required or new, before drafting begins.
2. Freeze the administrative information and device identification modules early. These two modules interlock with labelling, the declaration of conformity and the LAR authorisation letter; any name change triggers rework across the full document set.
3. Build the 5-year data ledger first. Organise sales, complaint and vigilance data by year, market and event type, and prepare closure certificates for every FSCA.
4. Unify cross-reference numbering. Use one numbering convention throughout so that in-module references and attachment numbers correspond exactly and nothing is unfindable during review.
5. Map the classification rationale rule by rule. The classification conclusion must state which rule applies to each feature and why the highest class is taken, leaving no gaps.
6. Run a reviewer-perspective walkthrough before submission. Have someone not involved in drafting read the dossier in module order and record every broken link.

5. Verification checklist

• □ Has it been confirmed whether the product falls under the 9-item Class A list or the 12-item Class B/C/D list?
• □ Have all 20 CSDT modules been identified, each marked as applicable or not applicable with reasons?
• □ Has the source technical documentation been rearranged into CSDT modules rather than uploaded as one wholesale translation?
• □ Has a ledger of 5 years of sales, complaint and vigilance data been built with characterisation statements?
• □ Does the classification rationale map rule by rule and explain the highest-class determination?
• □ Are cross-reference numbers consistent throughout and are attachments locatable?
• □ Have the administrative information and device identification modules been three-way checked against the labels and declaration of conformity?
• □ Has a person not involved in drafting completed one full walkthrough?

Regulatory information verified as of 30 October 2026.

In African markets, the GRZAN regulatory team focuses on jurisdictions such as Kenya, Nigeria, South Africa and Egypt and maintains a verification mechanism built on primary regulatory sources. Every regulatory conclusion it issues rests solely on official gazettes, the original text of competent authority guidelines and public legal databases, with the verification date stated; any figure, timeline or amount that cannot be located in an official source is marked as a practical estimate and is never presented as presumption.

GRZAN services cover market access strategy and risk classification; preparation and review of registration dossiers in CSDT, STED and CTD formats; selection and management of local authorized representatives (LARs); quality management system and GMP/GSDP compliance support; post-market vigilance, change management and recall response; import clearance and PVoC coordination; regulatory intelligence subscriptions and corporate compliance ledgers.

For a Kenya market access plan for a specific product, contact the GRZAN regulatory team at info@grzanglobal.com.