PPB · structured requirements

🇰🇪 Kenya IVD regulatory data

Explore the IVD requirements currently available for Kenya, organized by topic and linked to official sources.

7 facts2 dimensions2 official sourceslatest verification 2026-09-15

Changes after registration in Kenya

Source-linked rules for common changes to a registered IVD. Read the scope and conditions with each rule; unverified details are listed separately.

Does changing a device brand name or logo require an update?

A change to the registered brand name and a change to logo artwork can follow different rules. The legal manufacturer, device design and intended purpose remain the same.

A source-verified answer for this specific scenario is not yet published.

How do I update a manufacturer's name without changing the legal entity?

The same legal manufacturer changes its name, potentially alongside the device brand. A transfer to another legal entity is a separate question; permission to combine filings needs its own evidence.

A source-verified answer for this specific scenario is not yet published.

What changes when the manufacturer's office address changes?

An office address change for the same legal entity, potentially alongside name and brand changes. This does not cover moving a factory or manufacturing site, and a combined filing cannot be assumed.

A source-verified answer for this specific scenario is not yet published.

Does a catalogue or reference code change affect registration or UDI?

Check which identifier actually changes. A commercial catalogue, REF or order code is not automatically a device model, registered identifier, GTIN or UDI-DI. Rules for one identifier do not establish the route for another.

A source-verified answer for this specific scenario is not yet published.

Can a registration transfer to a different legal entity?

A real change of legal manufacturer, registration holder or owner. This differs from renaming the same entity; a change of local representative or importer alone does not establish a registration transfer route. Where other changes occur with the transfer, the exact combination and sequence need separate evidence.

A source-verified answer for this specific scenario is not yet published.

Can several changes be filed together?

Changes to brand, manufacturer name, office address and reference codes may occur together, including with a real transfer to another legal manufacturer, registration holder or owner. Assess transfer with each single change, and transfer with brand plus reference, manufacturer name plus reference, or office address plus reference changes: seven transfer combinations in total. Evidence must establish the exact combination and the order of filings and approvals. These combinations and their sequence are not all verified by the rules below; a rule for one change does not prove that a single application, fee or review period covers the combination.

A source-verified answer for this specific scenario is not yet published.

Classification rules

What local class follows from which rules and decisive product facts?

Compare countries

Classification detail 2

classification.detail-2

Fact-level verified

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

Classification detail 3

classification.detail-3

Fact-level verified

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

Classification detail 4

classification.detail-4

Fact-level verified

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)

Classification scheme (full axis)

classification.scheme-classes

Fact-level verified

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.

Reliance & recognition

Which foreign decisions or evidence can be reused, with what effect and conditions?

Compare countries

Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.

Kenya approvals and evidence in other markets (0 records)

No linked record is currently maintained. This does not establish that a pathway is unavailable.

Prior approvals and evidence for Kenya (6 records)

Prior approval / evidence record

WHO prequalification

Authority: WHO prequalification
Accepted: Yes
Benefit: WHO-listed products get the 7-day abridged review on the expedited pathway

PPB Marketing Authorization Decision Flow chart — Fig. 2 expedited (EUA) and Fig. 3 routine FIFO and fast-track timelines The Pharmacy and Poisons (Registration of Health Products and Technologies) Rules, 2022 (Legal Notice No. 100 of 2022) — rule 5 processing, rule 8 annual retention, rule 10 five-year validity

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

KenyaEU conformity assessment

Prior approval / evidence record

CE Mark (EU MDR)

Authority: CE Mark (EU MDR)
Accepted: Yes
Benefit: Opens the reliance route inside fast track, which replaces the 24-month FIFO review with a 90-day one

PPB Marketing Authorization Decision Flow chart — Fig. 2 expedited (EUA) and Fig. 3 routine FIFO and fast-track timelines The Pharmacy and Poisons (Registration of Health Products and Technologies) Rules, 2022 (Legal Notice No. 100 of 2022) — rule 5 processing, rule 8 annual retention, rule 10 five-year validity

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

Regulatory reference

China NMPA approval: not a PPB reference regulatory agency (eight-agency list)

reliance.china-nmpa-not-reference

Pending verification

Statement: PPB's abridged, expedited (EBR/ECR/EDR) and immediate (IBR) evaluation routes are available only to devices already approved by PPB's listed medical-device reference regulatory agencies: Australia TGA, Health Canada, EU Notified Bodies (MDD/AIMDD/IVDD certificates), Japan MHLW, US FDA (510(k) or PMA; 510(k)-exempt products excluded), Ireland HPRA, Saudi Arabia SFDA and Swissmedic. China NMPA is not among the eight agencies, so an NMPA registration certificate does not qualify a device for any abridged route; a device with no reference-agency approval goes to the full evaluation route.
Source Jurisdiction Id: china
Source Authority Id: nmpa
Source Approval: China NMPA medical device registration certificate (Class II/III) or Class I filing record
Target Jurisdiction Id: kenya
China Classes In Scope: NMPA Class II/III certificates and Class I filings; target Kenya Class B, C and D (abridged, expedited and immediate routes)
Edge Type: No Reliance Route
Market Access Strength: none
Regulatory Layer: Product Marketing
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

Abridged route requires approval from at least three reference agencies (Class B and Class C/D); expedited routes require three to five independent reference-agency approvals plus marketing history.
EU and TGA approvals count only if the device was reviewed by them and not registered under a Mutual Recognition Agreement.
PPB's 'independent' reference agencies are HC, MHLW, USFDA, TGA, EU-NB, Swissmedic and HPRA.
Independent verification is incomplete. Treat this record as a research lead, not a confirmed benefit or exclusion; see the 2026-09-15 independent review.

Effective from 2021-08-01

Source passage: Table 2: Types of marketing clearances or approvals from each country/region — 1. Australia: Australia Therapeutic Goods Administration (TGA) license; 2. Canada: Health Canada License; 3. European Union (EU) [...]; 4. Japan: Ministry of Health, Labour and Welfare (MHLW) License; 5. United States of America (USA): US FDA 510(K) clearance letter [510(K) exempted products do not qualify for abridged evaluation route.]; or US FDA PMA approval letter; 6. Ireland: Irish Health Products Regulatory Authority; 7. Saudi Arabia: Saudi Arabia Food and Drugs Authority; 8. Switzerland: Swiss Medic. [...] A medical device that has not obtained any prior approval from any of PPB's reference regulatory agencies at the point of application will be subject to the full evaluation route.

Regulatory reference

China NMPA approval: outside PPB reliance-guideline reference categories

reliance.china-nmpa-not-reference-reliance-guideline

Pending verification

Statement: PPB's Guidelines on Reliance Mechanisms (HPT/PER/GUD/091 Rev 0, January 2025) enumerate the reference authorities and institutions PPB relies on: WHO PQ/CRP/EUL, SRAs, WHO Listed Authorities, WHO transitional WLAs (Category A ML3/ML4 NRAs for vaccines, B SRA, C highly performing NRA for vaccines), continental and regional harmonisation bodies, EMA Article 58/Swissmedic MAGHP, NRAs with a PPB MoU at WHO ML3 or above, and 'Member of the International Medical Devices Regulators Forum as a founding member country'. China NMPA is not an SRA, not a WLA, and not an IMDRF founding member, so its decisions are not within PPB's recognised reference set.
Source Jurisdiction Id: china
Source Authority Id: nmpa
Source Approval: China NMPA medical device registration certificate (Class II/III) or Class I filing record
Target Jurisdiction Id: kenya
China Classes In Scope: all health products and technologies incl. medical devices and IVDs (reliance pathways)
Edge Type: No Reliance Route
Market Access Strength: none
Regulatory Layer: Product Marketing
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

A Reference Regulatory Authority for medical devices must be an IMDRF member whose decisions PPB can rely on; the list is reviewed 'from time to time based on WHO updates of WLA'.
Bilateral reliance requires an MoU or legally binding agreement with PPB and WHO ML3 or above.
Independent verification is incomplete. Treat this record as a research lead, not a confirmed benefit or exclusion; see the 2026-09-15 independent review.

Effective from 2025-01-01

Source passage: e) WHO Listed Authorities (WLAs)/SRA f) WHO Transitional WLAs (Category A, B and C)- Category A - ML3 & ML4 NRAs for vaccines only, Category B- SRA and Category C- Highly performing NRA (Vaccines) [...] j) Member of the International Medical Devices Regulators Forum as a founding member country. Note: The list of Reference Regulatory Authorities shall be reviewed from time to time based on WHO updates of WLA, changes in regulatory environment and adoption of best practices.

Prior approval / evidence record

China NMPA approval: origin evidence only

reliance.china-nmpa-origin-evidence

Pending verification

Statement: For listing of Class A medical devices PPB requires, among the submission documents, 'Regulatory approval from the country of origin of the product' together with proof of a quality management system. For a device made in China this documentary requirement is met by the NMPA registration certificate or Class I filing record; the requirement is evidentiary only and confers no abridged review.
Source Jurisdiction Id: china
Source Authority Id: nmpa
Source Approval: China NMPA medical device registration certificate (Class II/III) or Class I filing record
Target Jurisdiction Id: kenya
China Classes In Scope: NMPA Class I filing (备案) or Class II/III certificate as country-of-origin evidence; target Kenya Class A listing
Edge Type: Origin Country Evidence
Market Access Strength: Evidence Only
Regulatory Layer: Product Marketing
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

Applies to Class A listing (Table 4, item 8).
QMS proof (ISO 13485, US FDA QSR/CFS, Japan MHLW Ordinance 169 or CE certificate) is a separate requirement (item 9).
Independent verification is incomplete. Treat this record as a research lead, not a confirmed benefit or exclusion; see the 2026-09-15 independent review.

Effective from 2021-08-01

Source passage: 8. Regulatory approval from the country of origin of the product. 9. Proof of Quality Management System (QMS) – E.g. ISO 13485 certificate, conformity to US FDA Quality System Regulations (Certificate of free sale), Japan MHLW Ordinance 169 or attestation stating adequate QMS, CE Certificate from the EU/UK IRELAND

KenyaUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: Yes
Benefit: Recognised reference-authority decision for the same reliance route

PPB Marketing Authorization Decision Flow chart — Fig. 2 expedited (EUA) and Fig. 3 routine FIFO and fast-track timelines The Pharmacy and Poisons (Registration of Health Products and Technologies) Rules, 2022 (Legal Notice No. 100 of 2022) — rule 5 processing, rule 8 annual retention, rule 10 five-year validity

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

Related structured datasets

Classification systems · 1 record

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

Id

kenya:medical-device

Jurisdiction Id

kenya

Domains

medical-device
ivd

Name

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

Official Domains

pharmacyboardkenya.org

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.

Source Status

official-source-verified

Source Title

PPB — Guidelines for Registration of Medical Devices including In Vitro Diagnostics, Sections 2.1 and 2.15

Source Url

https://web.pharmacyboardkenya.org/download/guidelines-for-registration-of-medical-devices-including-in-vitro-diagnostics

Verified On

2026-08-25

Source Supports

class-axis
classification-rules
ivd-class-axis
ivd-classification-rules

Registration pathways, prior approvals and planning · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Kenya registration →

Country

Kenya

Jurisdiction Id

kenya

Country Code

KE

Flag

🇰🇪

Regulator

Pharmacy and Poisons Board

Regulator Abbrev

PPB

Region

africa

Tier

3

Risk Classification

4-class (A, B, C, D) — EU-aligned

Classes

Id
fifo
Class Name
All classes — first in, first out
Pathway
PPB marketing authorisation, default queue
Official Timeline
Min
24
Max
28
Unit
months
Verification Status
official-verified
Official Source
Title
PPB Marketing Authorization Decision Flow chart — Fig. 2 expedited (EUA) and Fig. 3 routine FIFO and fast-track timelines
Url
https://web.pharmacyboardkenya.org/download/marketing-authorisation-pathways/
Accessed Date
2026-08-30
Realistic Timeline
Min
24
Max
30
Unit
months
Notes
PPB publishes its clocks by pathway, not by device class: Fig. 3 gives screening 90 days, scientific review 24 months, approval by the Board 14 days and issue of the registration certificate 7 days
Two steps inside the same chart are expressly unbounded — assessor review time carries "No timeline" and review of the applicant's response carries "No target time" — so the 24 months is the review target rather than a guaranteed decision date
The applicant's own reply is capped at not more than 6 months
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
Yes
Id
fast-track
Class Name
All classes — fast track (reliance route)
Pathway
PPB marketing authorisation, priority queue
Official Timeline
Min
4
Max
5
Unit
months
Verification Status
official-verified
Official Source
Title
PPB Marketing Authorization Decision Flow chart — Fig. 2 expedited (EUA) and Fig. 3 routine FIFO and fast-track timelines
Url
https://web.pharmacyboardkenya.org/download/marketing-authorisation-pathways/
Accessed Date
2026-08-30
Realistic Timeline
Min
5
Max
9
Unit
months
Notes
Fig. 3: screening 30 days instead of 90, and the reliance review is 90 days instead of the FIFO 24 months, with the same 14-day Board approval and 7-day certificate issue
The chart publishes no review clock for the fast-track full-assessment route; this row is the reliance clock
Eligibility is set by the PPB reliance guidelines and the guidelines for fast-track review, not by risk class
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
Yes
Id
expedited-eua
Class Name
All classes — expedited review (emergency use authorisation)
Pathway
PPB emergency use authorisation
Official Timeline
Min
25
Max
48
Unit
days
Verification Status
official-verified
Official Source
Title
PPB Marketing Authorization Decision Flow chart — Fig. 2 expedited (EUA) and Fig. 3 routine FIFO and fast-track timelines
Url
https://web.pharmacyboardkenya.org/download/marketing-authorisation-pathways/
Accessed Date
2026-08-30
Realistic Timeline
Min
1
Max
3
Unit
months
Notes
Fig. 2: screening for completeness 3 days, review 30 days on the full assessment pathway or 7 days for abridged and WHO-listed products, and a final decision in 15 days
The low end of the range is the abridged and WHO-listed route (3 + 7 + 15); the high end is full assessment (3 + 30 + 15)
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
No

Key Requirements

Local representative appointed by agreement; any variation to that agreement must be notified to the Board within seven days (LN 100 of 2022, rule 4(4))
Rule 5 sets the substantive test — safety, efficacy, quality, performance and economic value — but puts no period on the Board, which is why the clocks come from the PPB pathway chart rather than from the Rules
Applications are filed on the PRIMS portal, which routes them to one of the three pathways at scheduling
Annual retention application and fee under rule 8, separate from the five-year renewal under rule 9
Immediate Class B Registration (IBR) route (guideline 2.4.1.4): a Class B device with at least three reference-agency approvals and four years of safe marketing is registered immediately on submission, listed on the PPB online registry within an hour, with email confirmation within 48 hours

Prior Approvals

Authority
CE Mark (EU MDR)
Accepted
Yes
Benefit
Opens the reliance route inside fast track, which replaces the 24-month FIFO review with a 90-day one
Authority
FDA 510(k)/PMA
Accepted
Yes
Benefit
Recognised reference-authority decision for the same reliance route
Authority
WHO prequalification
Accepted
Yes
Benefit
WHO-listed products get the 7-day abridged review on the expedited pathway

Local Rep Required

Yes

Local Rep Name

Kenyan Authorized Representative

Mdsap Accepted

No

Mdsap Benefit

Not accepted

Registration Validity

5 years — LN 100 of 2022 rule 10(1), and rule 10(2) keeps a certificate in force past expiry if the renewal application was filed in time

Last Updated

2026-08-30

Verification Status

partially-verified

Official Sources

Title
PPB Marketing Authorization Decision Flow chart — Fig. 2 expedited (EUA) and Fig. 3 routine FIFO and fast-track timelines
Url
https://web.pharmacyboardkenya.org/download/marketing-authorisation-pathways/
Accessed Date
2026-08-30
Title
The Pharmacy and Poisons (Registration of Health Products and Technologies) Rules, 2022 (Legal Notice No. 100 of 2022) — rule 5 processing, rule 8 annual retention, rule 10 five-year validity
Url
https://new.kenyalaw.org/akn/ke/act/ln/2022/100/eng@2022-12-31
Effective Date
2022-12-31
Accessed Date
2026-08-30

Reviewed On

2026-08-30

Process

Template Id

default

Status

planning-template

Usage Rule

Maintained planning steps and estimates, not verified regulator deadlines.

Steps

Step
1
Title
Pre-Submission Preparation
Description
Gather technical documentation, quality management system (QMS) records, and clinical data required by PPB. Appoint a Kenyan Authorized Representative.
Duration
1-3 months
Icon
📋
Step
2
Title
Application Submission
Description
Submit complete registration dossier to PPB including device description, risk analysis, and testing reports.
Duration
1-2 weeks
Icon
📤
Step
3
Title
Administrative Review
Description
PPB reviews application for completeness. May request additional documents or clarifications.
Duration
2-4 weeks
Icon
🔍
Step
4
Title
Technical Evaluation
Description
In-depth technical assessment of device safety and performance. PPB may issue questions.
Duration
2-2.3 years
Icon
⚙️
Step
5
Title
Registration Approval
Description
Upon successful review, PPB issues Kenya market authorization certificate.
Duration
1-2 weeks
Icon
✅

Government fee schedules · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Kenya fees →

Jurisdiction Id

kenya

Country

Kenya

Country Code

KE

Authority

PPB

Low Risk Local

Min: 50
Max: 50
Currency: USD
Per Product: Yes

High Risk Local

Min: 1000
Max: 1000
Currency: USD
Per Product: Yes

Details

Id
imported-registration-class-a
Item
Imported device registration - Class A
Currency
USD
Amount Local
100
Amount Local Formatted
USD 100
Frequency
Per product
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://web.pharmacyboardkenya.org/download/guidelines-for-registration-of-medical-devices-including-in-vitro-diagnostics
Source Title
Kenya PPB guidelines for registration of medical devices including IVDs, Table 6 fees
Verified On
2026-08-25
Id
imported-registration-class-b
Item
Imported device registration - Class B
Currency
USD
Amount Local
200
Amount Local Formatted
USD 200
Frequency
Per product
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://web.pharmacyboardkenya.org/download/guidelines-for-registration-of-medical-devices-including-in-vitro-diagnostics
Source Title
Kenya PPB guidelines for registration of medical devices including IVDs, Table 6 fees
Verified On
2026-08-25
Id
imported-registration-class-c-d
Item
Imported device registration - Class C/D
Currency
USD
Amount Local
1000
Amount Local Formatted
USD 1,000
Frequency
Per product
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://web.pharmacyboardkenya.org/download/guidelines-for-registration-of-medical-devices-including-in-vitro-diagnostics
Source Title
Kenya PPB guidelines for registration of medical devices including IVDs, Table 6 fees
Verified On
2026-08-25
Id
local-registration-class-a-b
Item
Locally manufactured registration - Class A/B
Currency
USD
Amount Local
50
Amount Local Formatted
USD 50
Frequency
Per product
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://web.pharmacyboardkenya.org/download/guidelines-for-registration-of-medical-devices-including-in-vitro-diagnostics
Source Title
Kenya PPB guidelines for registration of medical devices including IVDs, Table 6 fees
Verified On
2026-08-25
Id
local-registration-class-c-d
Item
Locally manufactured registration - Class C/D
Currency
USD
Amount Local
100
Amount Local Formatted
USD 100
Frequency
Per product
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://web.pharmacyboardkenya.org/download/guidelines-for-registration-of-medical-devices-including-in-vitro-diagnostics
Source Title
Kenya PPB guidelines for registration of medical devices including IVDs, Table 6 fees
Verified On
2026-08-25
Id
major-variation
Item
Variation of a registered medical device - imported product
Currency
USD
Amount Local
200
Amount Local Formatted
USD 200
Frequency
Per variation
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://web.pharmacyboardkenya.org/download/guidelines-for-registration-of-medical-devices-including-in-vitro-diagnostics
Source Title
Kenya PPB guidelines for registration of medical devices including IVDs, Table 6 fees
Verified On
2026-08-25
Id
minor-variation
Item
Variation of a registered medical device - locally manufactured product
Currency
USD
Amount Local
50
Amount Local Formatted
USD 50
Frequency
Per variation
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://web.pharmacyboardkenya.org/download/guidelines-for-registration-of-medical-devices-including-in-vitro-diagnostics
Source Title
Kenya PPB guidelines for registration of medical devices including IVDs, Table 6 fees
Verified On
2026-08-25
Id
retention-class-a-b
Item
Annual retention - Class A/B (imported and locally manufactured)
Currency
USD
Amount Local
50
Amount Local Formatted
USD 50
Frequency
Per product, annual
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://web.pharmacyboardkenya.org/download/guidelines-for-registration-of-medical-devices-including-in-vitro-diagnostics
Source Title
Kenya PPB guidelines for registration of medical devices including IVDs, Table 6 fees
Verified On
2026-08-25
Id
retention-class-c-d
Item
Annual retention - Class C/D imported product (locally manufactured USD 50)
Currency
USD
Amount Local
300
Amount Local Formatted
USD 300
Frequency
Per product, annual
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://web.pharmacyboardkenya.org/download/guidelines-for-registration-of-medical-devices-including-in-vitro-diagnostics
Source Title
Kenya PPB guidelines for registration of medical devices including IVDs, Table 6 fees
Verified On
2026-08-25
Id
general-health-product-registration
Item
General health-product registration (L.N. 100/2022)
Currency
USD
Amount Local
1000
Amount Local Min
500
Amount Local Max
1000
Amount Local Formatted
USD 500–1,000
Frequency
Per product
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://new.kenyalaw.org/akn/ke/act/ln/2022/100/eng@2022-12-31
Source Title
Kenya L.N. 100 of 2022 Second Schedule: health-product fees
Source Effective Date
2022-12-31
Verified On
2026-08-25
Id
donated-product-application
Item
Donated health-product application (L.N. 100/2022)
Currency
USD
Amount Local
0
Amount Local Formatted
USD 0
Frequency
Per application
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://new.kenyalaw.org/akn/ke/act/ln/2022/100/eng@2022-12-31
Source Title
Kenya L.N. 100 of 2022 Second Schedule: health-product fees
Source Effective Date
2022-12-31
Verified On
2026-08-25
Id
fast-track-review
Item
Fast-track review (L.N. 100/2022)
Currency
USD
Amount Local
2000
Amount Local Formatted
USD 2,000
Frequency
Per application
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://new.kenyalaw.org/akn/ke/act/ln/2022/100/eng@2022-12-31
Source Title
Kenya L.N. 100 of 2022 Second Schedule: health-product fees
Source Effective Date
2022-12-31
Verified On
2026-08-25
Id
emergency-use-authorisation
Item
Emergency use authorisation (L.N. 100/2022)
Currency
USD
Amount Local
2500
Amount Local Formatted
USD 2,500
Frequency
Per application
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://new.kenyalaw.org/akn/ke/act/ln/2022/100/eng@2022-12-31
Source Title
Kenya L.N. 100 of 2022 Second Schedule: health-product fees
Source Effective Date
2022-12-31
Verified On
2026-08-25

Notes

Table 6 of the PPB guideline splits every fee by imported vs locally manufactured product; annual retention is USD 50 for Class A/B (either origin) and USD 300 imported / USD 50 locally manufactured for Class C/D.
LN 100 of 2022 Second Schedule items 8-15 separately fix device registration and renewal fees at Class A USD 100, B 200, C 1,000, D 1,000, which differ from the guideline retention amounts.

Last Updated

2026-08-25

Verification Status

official-verified

Official Sources

Title
Kenya PPB guidelines for registration of medical devices including IVDs, Table 6 fees
Url
https://web.pharmacyboardkenya.org/download/guidelines-for-registration-of-medical-devices-including-in-vitro-diagnostics
Accessed Date
2026-08-25
Title
Kenya L.N. 100 of 2022 Second Schedule: health-product fees
Url
https://new.kenyalaw.org/akn/ke/act/ln/2022/100/eng@2022-12-31
Effective Date
2022-12-31
Accessed Date
2026-08-25

Reviewed On

2026-08-25

Amount Status

exact-current

Range Available

Yes

Additional certifications and licences · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Kenya certifications →

Slug

kenya

Market

Kenya

Confidence

low

Schemes

Id
ppb-in-country-ivd-performance-testing
Name
PPB in-country IVD performance testing
Category
Product Specific Conformity
Status
Included In Medical Registration
Object
Ivd Or Condom Device
Note
Section 2.15.2: in-country assessment for performance and evaluation is a mandatory pre-registration requirement for IVDs — samples with defined sample sizes must be submitted to the PPB Quality Control Laboratory department; an IVD that fails the performance-testing criteria will not be approved for registration; male latex condoms and other specified medical devices must also undergo laboratory testing.
Source Urls
https://web.pharmacyboardkenya.org/download/guidelines-for-registration-of-medical-devices-including-in-vitro-diagnostics
Source Binding
reviewed
Id
kebs-pre-verification-or-certificate-of-conformity
Name
KEBS Pre-Verification or Certificate of Conformity
Category
Import Conformity
Status
Mandatory At Import
Object
Class A Listing Or Import
Note
Class A listing requires a Pre-Verification certificate from a Notified Body in liaison with KEBS (Kenya Bureau of Standards); a Certificate of Conformity is also acceptable in place of PVoC (Table 4 item 3).
Source Urls
https://web.pharmacyboardkenya.org/download/guidelines-for-registration-of-medical-devices-including-in-vitro-diagnostics
Source Binding
reviewed
Id
ppe-certificate-of-analysis-and-biocompatibility
Name
PPE certificate of analysis and ISO 10993-1
Category
Product Specific Conformity
Status
Included In Medical Registration
Object
Personal Protective Equipment
Note
Table 4 item 6: face masks, surgical face masks and gloves require a certificate of analysis for conformity through a PPB-recognized laboratory; biological safety assessments should follow ISO 10993-1 (Section 2.2.1).
Source Urls
https://web.pharmacyboardkenya.org/download/guidelines-for-registration-of-medical-devices-including-in-vitro-diagnostics
Source Binding
reviewed

Official Sources

Authority
Pharmacy and Poisons Board (PPB)
Topic
registration guidelines — in-country IVD testing, KEBS pre-verification, PPE certificate of analysis
Url
https://web.pharmacyboardkenya.org/download/guidelines-for-registration-of-medical-devices-including-in-vitro-diagnostics

Keep researching this market

View the Kenya resource hub →

Continue with this market

Need to apply Kenya's requirements to a product?

Confirm the current PPB pathway, evidence, and local-role details for the actual device before filing.