General
|
| Country: |
Nigeria |
| Geographic region: |
West Africa |
| Income level (World bank): |
Lower middle income |
| Population (women 15-49 years) in millions, 2015: |
41,4 |
| Are condoms (male/female) regulated in the country? |
yes |
| If yes, describe the applicable regulation or directive: |
Guidelines for registration of imported medical devices in Nigeria NAFDAC/RR/007/00 |
| Condom classification (medical device, medicines, others): |
Medical device |
| National competent (regulatory) authority: |
National Agency for Food And Drug Administration and Control (NAFDAC) |
Essential Medicines List
|
| Condoms on EML? |
yes |
| Female condoms specified on EML? |
no |
| EML Version (year): |
2010 |
Registration Requirements
|
| Applicant eligibility: |
Manufacturer or authorised local representative |
| Administrative documents: |
"Written application; Evidence of trademark approval; Certificate of business incorporation (of the importing country). All documents should be authenticated by Nigerian Embassy in the country of origin. " |
| Technical documents: |
"Certificate of manufacture; Free sale certificate; Certificate of analysis" |
| Sample: |
Sample of product and labeling materials |
| Timeline: |
60 days after submission of sample |
| Registration Fee: |
N 250,000 + 5% vAT |
| Validity of registration: |
5 years |
