Welcome to Kenya's Trade Information Portal More information
Official Kenya Government website

A .go.ke website belongs to an official government organization in Kenya. The Kenya Trade Information Portal is managed by the Kenya Trade Network Agency (KenTrade)

Secure .go.ke websites use HTTPS

A lock ( ) or https:// means you're safely connected to the .go.ke website.

Share sensitive information only on official, secure websites.

Summary print

Preview & Print

Properties

Steps (46) arrow_drop_up arrow_drop_down
Register with Pharmacy and Poisons Board (PPB) online service portal  (2) expand_more expand_less
Obtain wholesale dealer's licence and certificate of premise registration  (6) expand_more expand_less
Obtain medical device listing  (3) expand_more expand_less
Register with KESWS  (4) expand_more expand_less
Obtain import declaration form  (2) expand_more expand_less
Obtain medical devices import permit  (5) expand_more expand_less
Pre-clearance documentation  (1) expand_more expand_less
Obtain delivery order  (4) expand_more expand_less
Obtain KEBS consignment document  (1) expand_more expand_less
Obtain passed clearance entry  (3) expand_more expand_less
Obtain KEBS release  (1) expand_more expand_less
Obtain PPB release  (2) expand_more expand_less
Obtain certificate of radioanalysis  (2) expand_more expand_less
Obtain Kenya Nuclear Regulatory Authority release  (1) expand_more expand_less
Obtain KRA release  (3) expand_more expand_less
Obtain KPA release  (4) expand_more expand_less
Obtain gate pass  (2) expand_more expand_less

9
Apply for listing of medical device including In-Vitro Diagnostics
(last modified: 21/04/2020)

You can apply for this step online

language Apply online

Where to go?

Entity in charge

Pharmacy and Poisons Board (PPB) Trade Portal

What do I get?

Pharmacy and Poisons Board (PPB) invoice

What are the requirements?

1. 01 - Libre deuda de patente
ISO 13485:2016 certificate (copy)
Of the manufacturing site.
2. 01 - Libre deuda de patente
Certificate of free sale (copy)
From the country of origin for goods originating from the US market.
or 01 - Libre deuda de patente
CE (European Conformity) certificate (copy)
From the country of origin, for goods originating from the EU/ UK/ Ireland markets.
3.
Regulatory approval certificate (copy)
Of the manufacturing site from the country of origin.
4. 01 - Libre deuda de patente
Certificate of analysis (copy)
From the country of origin, where applicable.
5. 01 - Libre deuda de patente
Pre - verification certificate (copy)
From the country of origin issued in liaison with the Kenya Bureau of Standards (KEBS).
6. 01 - Libre deuda de patente
Product packaging (copy)
An electronic scanned copy of the actual primary and secondary packaging of the product.
7. 01 - Libre deuda de patente
Instructions for use (copy)
For the medical device being imported.

Time frame

Attention at counter: Max.   5h.

Legal justification

1. Health Act 2017
Health Act 2017
articles 62, 63

Recourse: Pharmacy and Poisons Board (PPB)

Entity in charge

Pharmacy and Poisons Board (PPB)

P.O. Box 00506-27663, Lenana Road Opp. Department of Defence, Nairobi
Tel: +254 203 562 107 / +254 720 608 811
Email: enquiries@pharmacyboardkenya.org, info@pharmacyboardkenya.org
Website: http://pharmacyboardkenya.org/
Directions: Google maps

Unit in charge

Office of the Head, Product Evaluation and Registration Department (PPB)

Mon: 08:00 - 13:00, 14:00 - 17:00
Tue: 08:00 - 13:00, 14:00 - 17:00
Wed: 08:00 - 13:00, 14:00 - 17:00
Thu: 08:00 - 13:00, 14:00 - 17:00
Fri: 08:00 - 13:00, 14:00 - 17:00
Sat: closed
Sun: closed

Contact person

Dr. Ahmed I. Mohammed

Director, Product Evaluation and Registration
Tel: +254 733 884 411 / +254 720 608 811
Email: drug_reg@pharmacyboardkenya.org, medicaldevices@pharmacyboardkenya.org
Powered by eRegulations ©, a content management system developed by UNCTAD's Business Facilitation Program and licensed under Creative Commons License