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Summary print

Preview & Print

Properties

Steps (3) arrow_drop_up arrow_drop_down
Obtain medical device listing  (3) expand_more expand_less

1
Apply for medical device emergency authorization
(last modified: 08/05/2020)

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 manufacturer of the listed COVID -19 Rapid Test Kit.
For more information on IS0 13485:2016, click here.
2.
Pre - market approval
For each of listed COVID-19 Rapid Test Kit from at least one of the six jurisdictions recognised by Pharmacy and Poisons Board (South Africa Saphra, Australia, Brazil, Canada, Europe, Japan, United States of America) or pre-qualified by the World Health Organization.
3. 01 - Libre deuda de patente
Certificate of free sale (copy)
Confirming that each listed listed COVID-19 Rapid Test Kit is legally sold or distributed in the open market, freely without restriction and approved/listed by the regulatory authority 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)
A copy of the labelling and packaging for each listed COVID-19 Rapid Test Kit.
7. 01 - Libre deuda de patente
Instructions for use (copy)
For each listed COVID -19 Rapid Test Kits.
8.
Product description
Comprehensive description of the components of the product (Test Kit); including its unique features for positive and negative controls and ancillary reagents.

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
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