Tanzania

General

Country: Tanzania
Geographic region: East Africa
Income level (World bank): Low income
Population (women 15-49 years) in millions, 2015: 11,9
Are condoms (male/female) regulated in the country? yes
If yes, describe the applicable regulation or directive: Tanzania Food and Drugs Cosmetics Act 2003, section 52(1) and 21(1)
Condom classification (medical device, medicines, others): Class C medical device

Essential Medicines List

Condoms on EML? yes
Female condoms specified on EML? no
EML Version (year): 2013

Registration Requirements

Applicant eligibility: Manufacturer or local authorised permit holder - Must be first registered with TFDA by submitting completed application form; business registration certificate; application fee
Administrative documents: Completed application form;
Technical documents: Device details; Device description & details; Summary of design verification & validation; Evidence of conformity to essential principles of safety and performance of medical devices; Pre-clinical studies; Clinical evidence; Risk analysis; Manufacturing information
Sample: 5 samples should be submitted at the time of application
Process: Separate complete dossier in hard copy and electronic copy (CD-ROM). After the initial screening, if the dossier is accepted for full evaluation, evaluation fee shall be paid. After evaluation, a regulatory decision is given.
Timeline: 270 days after acceptance of dossier and payment of fees
Registration Fee: Screening fee US$ 50 and evaluation fee US$ 750
Validity of registration: 5 years
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