Général
|
| Pays |
South Africa |
| Région géographique: |
Southern Africa |
| Le niveau de revenu (Banque mondiale ): |
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 |
