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
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