🇰🇪 Kenya medical device regulatory data

PPB's Guideline for Advertisement and Promotion of Health Products and Technologies covers medicines and medical devices; it sets out elements of advertisement and promotion, restrictions, and application procedures for obtaining approval to advertise and promote, and addresses advertisements not approved by the Medicines Regulatory Authority.

Under section 36(1) of the Pharmacy and Poisons Act (Cap. 244), no person shall advertise any drug or poison except with the written permission of the Board; related provisions (ss.37-39) prohibit advertisements for certain diseases and misleading or extravagant claims.

A certificate of registration is valid for 5 years from the date of issue (rule 10(1), L.N. 100 of 2022; also section 2.12 of the registration guideline). In an emergency situation or in the public interest, PPB can at its discretion issue a certificate of registration valid for 2 years.

Renewal of registration is applied for using Form 4 (First Schedule) and must comply with the prescribed guideline for re-registration and renewal; if a renewal application is filed before expiry, the certificate remains in force until the Board makes a decision on the application.

All medical devices and IVDs must be annually retained in the PPB database to maintain market authorization status in Kenya; the retention procedure should be done three months before the end of the year, submission opens 60 days before the retention due date, and an annual retention fee is payable via the PPB online portal. Failure to pay may lead to suspension and cancellation of the registration.

The Pharmacy and Poisons Board (PPB) is the national regulator for medical devices and IVDs in Kenya, established under section 3 of the Pharmacy and Poisons Act (Cap. 244); section 3B(1) makes the Board responsible for the regulation of health products and technologies and the profession of pharmacy.

Changes to a registered medical device that can affect its safety, quality or efficacy must be approved prior to the modified device being supplied in Kenya, unless otherwise indicated; applicants are required to notify changes concerning registered medical devices to the Authority, and each simultaneous change must be assessed separately.

Certain changes do not qualify for change notification and require submission of a new CSDT application, including: change to the intended purpose of a registered medical device; change to the risk classification of the device; change to the medicinal substance in a device incorporating a medicinal product in an ancillary role; and adding devices with different proprietary names into a single-family listing.

Under rule 13 of the 2022 Registration Rules the Board may, by written notice, vary the certificate and enter the variation in the Register; certificate holders must report any quality and safety changes or any defect which could impact patient safety of a marketed product.

Classification is determined rule-based by the manufacturer: categories are non-invasive devices, invasive devices (body orifice / surgically invasive), active devices, and exceptional classes (devices incorporating medicinal substances, non-viable animal tissues, sterilizers/disinfectants, ophthalmic solutions, contraception/STD prevention, long-term implants); where a device falls into more than one class the highest applies, and the actual classification is determined by the manufacturer based on intended use

IVDs are classified into four classes A-D: Class A (low individual and low public health risk, e.g. clinical chemistry analyser), Class B (moderate individual/low public health risk, e.g. pregnancy self-testing, urine test strips), Class C (high individual/moderate public health risk, e.g. blood glucose self-testing, PSA screening, rubella), Class D (high individual and high public health risk, e.g. HIV blood donor screening/diagnostic); classification criteria are intended use/indications, technical expertise of the intended user (lay vs professional), and importance of the information to diagnosis and public health impact

IVD classification rules: Rule 1 classifies IVDs intended for certain listed purposes as Class D (per Section 2.15.3, which sets out numbered rules assigning IVDs to Classes A-D)

Axis

Risk classes A through D for devices and IVDs (PPB registration guidelines).

Classes

• Id

  a

  Label

  Class A

  Normalized Risk Level

  low

• Id

  b

  Label

  Class B

  Normalized Risk Level

  medium

• Id

  c

  Label

  Class C

  Normalized Risk Level

  high

• Id

  d

  Label

  Class D

  Normalized Risk Level

  highest

Regulator

PPB

Notes

• Classification based on intended purpose, intended user, duration of contact, degree of invasiveness, delivery of medicinal products or energy, and biological effect (IMDRF-style); where a device has features in more than one class, the highest class applies (Section 2.1, Table 1).
• Rule categories: non-invasive, invasive (body-orifice / surgically invasive), active, and exceptional classes (devices incorporating medicinal substances, non-viable animal tissues, sterilizers/disinfectants, ophthalmic solutions, contraception/STD prevention, long-term implants); the actual classification is determined by the manufacturer based on intended use (Section 2.1.1).
• IVDs: Class A low individual/low public risk (e.g. clinical chemistry analyser), B moderate/low (pregnancy self-testing, urine strips), C high/moderate (blood glucose self-testing, PSA screening, rubella), D high/high (HIV blood-donor screening); criteria are intended use, technical expertise of the intended user (lay vs professional), and importance of the information to diagnosis and public health impact (Section 2.15.1, Table 8); numbered IVD classification rules in Section 2.15.3.

Clinical evaluations are required for all medical devices; if a pre-market clinical investigation has been conducted the documentation should be provided, and supporting evidence must be provided for any claims made in labelling or marketing literature.

For devices registered via the Immediate Class B Registration (IBR) route whose labelled use goes beyond the inherent performance of the device, additional clinical data may be requested post-registration to substantiate the proposed labelled use.

An in-vitro diagnostics medical device is defined in the 2022 Registration Rules as a device intended by the manufacturer for the in vitro examination of specimens derived from the human body.

PPB has issued a Guideline on Regulation of Medical Device Software in Kenya (MDSW) covering Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD), with risk classification harmonized with IMDRF and WHO frameworks and covering cybersecurity, data protection, AI/ML considerations and lifecycle oversight from approval to post-market monitoring.

Kenya applies a GHTF-style definition: a medical device is any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for humans for diagnosis, prevention, monitoring, treatment or alleviation of disease, and other listed medical purposes.

Product registration applications for medical devices submitted to PPB must be prepared in the Common Submission Dossier Template (CSDT) format, which is based on the IMDRF STED guidance; administrative information must include the Local Representative Person details domiciled in Kenya.

Applicants must provide sales, complaints and vigilance data for the last five years, including full details of vigilance issues and the status of any Field Safety Corrective Actions or Notices.

PPB registers all Local Authorized Representatives (LAR) for medical devices in Kenya; only one LAR may be identified and this must be consistent across device labels and Declarations of Conformity; the requirement is mandatory before registration approvals are granted. LAR duties include acting as primary contact point with the authority, keeping the technical file available, adverse event and incident notification (with a declaration to provide regular vigilance reports to PPB), supply-chain compliance, product safety vigilance reporting, FSCA implementation/management/coordination and reporting, and annual technical file review. Any manufacturer based outside Kenya must designate an LAR with written evidence (Letter of Authorization, Annex 1 template).

Under rule 4(2)(b) of the 2022 Registration Rules, an applicant who is not resident in Kenya (foreign manufacturer) must appoint a local representative who is a citizen of Kenya, a person with permanent residence, or a company incorporated in Kenya.

Manufacturers, importers and distributors of medical devices in Kenya are regulated through registration of medical device establishments under the Pharmacy and Poisons Act; establishments are expected to have an established quality management system (ISO 13485:2016) to ensure continued safety, quality and performance of devices throughout the product life cycle and supply chain. Applications are made via the PRIMS portal following the Guideline for Registration of Medical Devices Establishments.

Under sections 3A(e) and 3B(2)(e) of Cap. 244 the Board grants or revokes licences for the manufacture, importation, exportation, distribution and sale of medicinal substances. Import/export permits are applied for and evaluated through PPB's online system (products portal); health products and technologies must be imported through designated and gazetted ports, where the Ports of Entry unit verifies import/export documents and inspects consignments for Good Distribution Practice compliance.

The application fee is payable at the time of submission via the PPB online portal and evaluation fees upon acceptance for evaluation; application fees are non-refundable once the application has been successfully submitted, and evaluation fees are non-refundable once the application is accepted regardless of the final decision - withdrawal after acceptance or rejection by PPB results in forfeiture of evaluation fees. IBR route fees are charged immediately upon successful submission and are not refunded if the application fails the criteria.

For the registration dossier it is sufficient to show labelling information in English only, but items to be translated and the translation plan should be indicated; legible versions of all levels of labels (primary and secondary packaging) representative of the finished form and showing all symbols must be provided, including labels, IFU, patient implant cards, surgical manuals and brochures.

Binding regime: Pharmacy and Poisons Act (Cap. 244) and the Pharmacy and Poisons (Registration of Health Products and Technologies) Rules, 2022 (L.N. 100 of 2022), which contain the application (Form 1), local-representative, dossier, variation (rule 13), renewal (Form 4), five-year validity (rule 10(1)) and fee (Second Schedule) provisions. Operative guidance: PPB 'Guidelines for Registration of Medical Devices Including In-Vitro Diagnostics' (HPTPERHTPGUD011, created April 2022).

Marketing authorization holders must monitor the safety of their products on the market and comply with pharmacovigilance; the manufacturer must establish, document and maintain throughout the device life-cycle an ongoing risk management process per ISO 14971 and a Quality Management System aligned with ISO 13485:2016, with risk management linked post-market to production/process controls, CAPA, servicing and customer feedback.

PPB requires marketing authorization holders to nominate a Qualified Person for Pharmacovigilance (QPPV) - a 'Final Notice on Nomination of QPPV' was issued to MAHs and local technical representatives, and PPB maintains 'Guidelines for Establishment of the Qualified Persons for Pharmacovigilance'.

Applications are submitted through the PPB online portals: PRIMS (prims.pharmacyboardkenya.org) for marketing authorization and establishment applications, with an invoice generated upon completion of the form and payment required to complete the application; portal.pharmacyboardkenya.org serves IBR submissions; import/export permits run through the products portal. Statutory forms under L.N. 100 of 2022: Form 1 (application for registration, First Schedule) and Form 4 (renewal).

Before submitting an application for marketing authorization of medical devices or IVDs, the applicant must first apply for GMP inspection, per the PPB GMP inspection and compliance procedure.

Applicants must provide proof of a Quality Management System, e.g. an ISO 13485 certificate, conformity to US FDA Quality System Regulations (certificate of free sale), Japan MHLW Ordinance 169, CE certificate from EU/UK/Ireland, or an attestation stating adequate QMS; copies of ISO 13485 certificates of new key subcontractors must also be provided.

Regulatory actions taken by the Board on device safety may include recalling the device, reclassifying it, or ordering a redesign from the manufacturer or another; the Board may request the MAH to conduct a concise critical analysis of the device's safety and performance and submit results within a specified time frame, and issues safety alerts and advisories to healthcare professionals on serious adverse incidents and FSCAs. PPB market surveillance protects public health through timely regulatory actions including recalls, alerts and withdrawals, with products sampled and tested in accredited labs.

The manufacturer must report to PPB in a timely manner, directly or through its authorized representative, any Field Safety Corrective Actions it is undertaking within Kenya; Field Safety Notices and FSCAs, including those based on incidents occurring outside Kenya, must be submitted in periodic summary reports with full details of vigilance issues and FSCA status, completed using the current WHO FSCA and FSN reporting template. The MAH must disseminate the FSN to all relevant stakeholders only after obtaining approval from the Board.

A Class B medical device that has obtained at least two reference regulatory agency approvals for a labelled use identical to that intended for marketing in Kenya qualifies for the abridged evaluation route.

A Class C or D medical device qualifies for the abridged evaluation route if it has obtained at least three reference regulatory agency approvals for a labelled use identical to that intended for marketing in Kenya at the time of submission.

Class A medical devices are registered through a listing-type review: documents are submitted via the PPB online portal (prims.pharmacyboardkenya.org), the application fee is charged immediately, PPB reviews the submitted data set, may issue input requests, and only applications satisfying the registration requirements are registered and listed.

A Class B device may use the EBR route if it: (1) has approvals from at least two of PPB's independent reference regulatory agencies for an identical labelled use; (2) has been marketed for at least three years in those agencies' jurisdictions; and (3) has had no safety issues globally in the last three years (no reported deaths, no reported serious deterioration in health, and no open field safety corrective actions including recalls at the point of submission).

A Class C (or D) device may use the ECR/EDR route if it either: (a) has approvals from at least three of PPB's independent reference regulatory agencies for an identical labelled use AND has been marketed for at least five years in those jurisdictions AND has no safety issues globally in the last three years (no deaths, no serious deterioration, no open FSCAs); or (b) has approvals from at least five of PPB's independent reference regulatory agencies.

Class B medical devices have four evaluation routes: Full Evaluation, Abridged Evaluation, Expedited Class B Registration (EBR) and Immediate Class B Registration (IBR). Class C and D and IVD medical devices have three: Full Evaluation, Abridged Evaluation, and Expedited (ECR for Class C, EDR for Class D). Devices without prior approval from any reference regulatory agency are subject to the full evaluation route.

A Class B device may use the IBR route if it: (1) has approvals from at least three of PPB's independent reference regulatory agencies (HC, MHLW, USFDA, TGA, EU-NB, SWISSMEDIC, HPRA) for an identical intended use; (2) has been marketed for at least four years in two of those jurisdictions; and (3) has no safety issues globally in the last three years and no rejection/withdrawal by any reference agency or Kenya. Devices are registered immediately and listed in the PPB Online registry within an hour, with email notification within 48 hours of submission; PPB verifies documents post-registration.

All medical devices including in-vitro diagnostic medical devices must be registered with PPB prior to placing them on the Kenyan market, unless exempted by the Regulations.

Where the medical device under application is the subject of a Field Safety Corrective Action (FSCA), the application is placed on stop-clock until resolution of the FSCA.

The target turn-around-time (TAT) for product registration applications commences from the date of receipt of the application and does not include stop-clock time due to input requests. The stop-clock starts whenever PPB issues an input request and ends when PPB receives a complete and satisfactory response from the applicant.

PPB grants Emergency Use Authorization (EUA) as a risk-based expedited pathway for products addressing urgent threats such as pandemics, epidemics and chemical, biological, radiological and nuclear incidents; eligible products include therapeutics, vaccines, blood products, biotherapeutics, in-vitro diagnostics and critical medical devices. EUA is granted only where potential benefits outweigh the risks based on preliminary quality, safety and efficacy evidence and where no registered alternatives exist; the framework covers pre-emergency planning, emergency phase authorization and post-authorization safety monitoring with transition to full registration.

PPB's Guideline on Evaluation and Authorisation of Unregistered Health Products and Technologies provides a route for accessing unregistered products urgently required to address unmet patient medical needs; it applies to manufacturers, importers, healthcare providers, health institutions and licensed dealers, and authorizations are granted in compliance with the Pharmacy and Poisons (Registration of Health Products and Technologies) Rules, 2022, with eligibility/needs assessment, evaluation timelines, renewal procedures, record-keeping and pharmacovigilance obligations.

Under section 42B of the Pharmacy and Poisons Act, appeals against specified decisions (under ss. 27(2), 28(3), 32(5), 50(2)) shall be in writing and lodged within thirty days after the date of the act appealed against; certain refusals/revocations under s.27(2) lie to the Cabinet Secretary, whose decision is final.

Under rule 5(5) of the 2022 Registration Rules the Board may only reject an application after providing the applicant an opportunity to be heard, and must inform the applicant of the reasons for rejection in writing; under rule 11(3) the Board must give notice and an opportunity to be heard before suspension or cancellation of a certificate.

Statement

The A&T standard's product dataset for medical devices includes a 'Unique Device Identification (UDI)' field described as a series of alpha-numeric characters assigned by the PPB to a medical device, which 'will be the national unique code (descriptive, logical and meaningful)'. The device field list in the same annex also carries the manufacturer's own identifiers alongside it — device family, device group, device class (A to D), GMDN name and code, make/model, and a manufacturer-assigned serial number for equipment — so the national identifier is a distinct field additional to the manufacturer's model and serial numbers.

Identifier Issuer

Pharmacy and Poisons Board

Dataset

Annex I, Products (Pharmaceuticals and Medical Devices)

Companion Fields

device family; device group; device class A-D; GMDN name; GMDN code; device accessories; make/model; serial number; quality and standards (CE, KEBS, ISO 13485)

Statement

Kenya's national authentication-and-traceability standard imposes the mandatory unit-level unique-identifier rule on medicines. Section 2.2 (Standards) requires all serialized units of medicines (individual packages) to be assigned a unique identifier (Global Trade Item Number plus Serial Number) compliant with GS1 standards — GS1-128 with Application Identifier 01 and a unique 20-digit serial number. Medical devices are inside the standard's product scope but are not the subject of that mandatory rule: the only place devices appear in the rollout is Phase 4 (Full-Scale Serialized Authentication and Traceability), whose requirement is to '[e]xtend the serialization requirements to all regulated medicines and potentially other high-risk medical devices'. On the face of the standard, therefore, no mandatory serialization or UDI-carrier obligation for medical devices is in force.

Mandatory For

medicines (individual saleable packages)

Device Obligation

none stated; Phase 4 (full-scale rollout) names 'potentially other high-risk medical devices' as a future extension

Identifier Standard

GS1-128 with Application Identifier 01 (GTIN-14) plus a unique 20-digit serial number; batch/lot AI (10), expiry AI (17), serial AI (21)

Statement

The A&T standard requires verification and authentication to be performed at every location throughout the entire supply chain — manufacturer, importer, distributor/wholesaler — as the first requirement of its A&T methodology, and requires every change of ownership in the supply chain to be accompanied by traceability documentation or verification and authentication. PPB has chosen the centralised model: all A&T data (unique identifiers — GTIN, serial numbers, SSCC — product information such as name, batch number and expiry date, and transaction data for manufacturing, distribution and dispensing) are stored in a centralised, secure database managed by the PPB, either directly or with A&T service providers, and verification of identifiers may be carried out by government agencies (national and county), supply-chain participants, medical professionals and patients against that repository.

Verification Point

every location in the supply chain; every change of ownership

Repository

centralised PPB-managed database

Who May Verify

government agencies (national and county), supply-chain participants, medical professionals, patients

The manufacturer must investigate serious events and submit investigation reports to the Board as soon as possible but not later than 15 days; all other reportable events must be reported as soon as possible but not later than 30 elapsed calendar days following the date of awareness.

Adverse events that result in unanticipated death, unanticipated serious injury, or represent a serious public health threat must be reported to the Board immediately and not later than 2 calendar days after awareness by the manufacturer.

The manufacturer, directly or through its authorized representative, must report to the Board adverse events associated with medical devices that occurred in Kenya when: (a) an event has occurred (malfunction or deterioration in performance; incorrect or out-of-specification test result; design flaw discovered during design review; inaccuracy in labelling, IFU or promotional materials; serious public health threat; use error); (b) the manufacturer's device is associated with the event; and (c) the event led to death, serious injury, or a near incident. Incidents occurring outside Kenya that do not lead to an FSCA relevant to Kenya need not be reported.

All serious and non-serious incidents/events that occurred in Kenya are reported to the Board using the medical devices incident reporting form (Annex 4) at pv.pharmacyboardkenya.org; PPB's general instruction is to report all suspected adverse events through the online reporting tool PvERS as soon as possible. PPB also maintains a Medical Devices Diagnostics Incident Form (Green) among its manual reporting forms, and manufacturers have primary responsibility (directly or through the authorized representative) for notifying users of device problems.