Kenya

General

Country: Kenya
Geographic region: East Africa
Income level (World bank): Low income
Population (women 15-49 years) in millions, 2015: 11,4
Are condoms (male/female) regulated in the country? yes
If yes, describe the applicable regulation or directive: Guidelines on submission of documents for registration of medical devices, Sep 2011
Condom classification (medical device, medicines, others): Class C medical device
National competent (regulatory) authority: Pharmacy and Poisons Board, Kenya

Essential Medicines List

Condoms on EML? yes
Female condoms specified on EML? yes
EML Version (year): 2010

Registration Requirements

Applicant eligibility: Local authorised representative if the manufacturer is based outside of Kenya
Administrative documents: Details of the applicant and/or local representative
Technical documents: "Description of the device; List of regulatory approvals; Information on safety & performance; Evidence to demonstrate conformity with essential principles of safety & performance; Pre-clinical and clinical studies; Manufacturing details"
Sample: Samples of product, labels and packaging materials
Process: Upon submission and verification of application, fee will be charged and a technical review committee will perform the full evaluation
Timeline: 90 calendar days after acceptance of application and payment of evaluation fee
Registration Fee: Registration fee - US$ 200; Evaluation fee - US$ 250;
Validity of registration: 5 years
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