South Africa

General

Country: South Africa
Geographic region: Southern Africa
Income level (World bank): Upper middle income
Population (women 15-49 years) in millions, 2015: 14,4
Are condoms (male/female) regulated in the country? yes
If yes, describe the applicable regulation or directive: Medicines Control council
Condom classification (medical device, medicines, others): Class C medical device
National competent (regulatory) authority: South African Bureau of Standards (SABS)

Essential Medicines List

Condoms on EML? yes
Female condoms specified on EML? yes
EML Version (year): 2008

Registration Requirements

Applicant eligibility: Manufacturer or local authorised permit holde
Administrative documents: application form
Technical documents: as descrived in common Technical Docuements (http://www.ich.org/products/ctd.html)
Process: Complete application form, Submit the completed aplicaiton to the Council, Pay the Fee, Ensure conformity assessment evidence, appropriate conformity assessment, sufficient information to sustantiate the application of those conformity assessment procedures, information included is complete and correct
Validity of registration: 5 years
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