General |
| Country: |
Ghana |
| Geographic region: |
West Africa |
| Income level (World bank): |
Lower middle income |
| Population (women 15-49 years) in millions, 2015: |
6,9 |
| Are condoms (male/female) regulated in the country? |
yes |
| If yes, describe the applicable regulation or directive: |
Section 148 of the Public Health Act 2012, Act 851 and related guidelines |
| Condom classification (medical device, medicines, others): |
Class II medical device |
| National competent (regulatory) authority: |
Food and Drugs Authority (FDA), Ghana |
Essential Medicines List |
| Condoms on EML? |
yes |
| Female condoms specified on EML? |
yes |
| EML Version (year): |
2010 |
Registration Requirements |
| Administrative documents: |
Completed application form; |
| Technical documents: |
"Device description & details; Summary of design verification & validation; Evidence of conformity to essential principles of safety and performance of medical devices; " |
| Sample: |
Sample of product as per FDA sample schedule |
| Process: |
Hard copes and electronic copies of the whole documentation to be submitted. Application will be evaluated by a drug registration committee on a first-in-first-out basis unless it meets the criteria for expedited review. New manufacturing facilities will be subject to site inspection to ensure compliance with cGMP standards. |
| Registration Fee: |
US$ 1500 |
| Validity of registration: |
3 years |
