Ministry of Health

Ministry of Health, Community Development, Gender, Elderly and Children (MoHCDGE)

Regulatory Authority

Tanzania Medicines and Medical Devices Authority (TMDA)

Medical Device Regulation

The Tanzania Food, Drugs and Cosmetics (Control of Medical Devices) Regulations, 2015

Official Language

Swahili and English

Classification

Class A, B, C and D

Registration Process

• Determine the device classification
• Appoint an authorized representative
• Prepare the Application form and Registration documents.
• For foreign manufacturers, Import Permit will be required
• Submit the applicable documents to the TMDA.
• Once approved, the product can be marketed in 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