Medical Device Registration in
Ministry of Health
Medical Device Regulation
Swahili and English
Class A, B, C and D
- 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.
- Application Form
- Payment fee receipt
- 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)
- Death or serious deterioration in the state of health – 24 hours
- Other incidents – 14 days
Import Permit is valid for 6 months