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 |
