Tanzania

Documents Required

• Application Form
• Payment fee receipt
• Sample
• Letter of Authorization
• Power of Attorney
• Class A – Copies of label, IFUs, Patient Information Leaflet, Sterilization Validation Report (if applicable), Certification of metrology or equivalent, Certification of electrical safety standards
• Class B, C & D – Product description, Regulatory approval from other countries, Risk Assessment plan, QMS certificate, Raw material & packaging specifications, Manufacturing process, List of applicable standards, Clinical Studies Report, Evidence of Biological safety (if present)

Post-market Requirements

• Death or serious deterioration in the state of health – 24 hours
• Other incidents – 14 days

Applicable QMS

ISO 13485

Authorized Representative

Yes.

License Validity

5 years

Special Notes

Import Permit is valid for 6 months