1.
Application form for registration of medical devices (original)
or
Application form for registration of in vitro diagnostics devices (original)
2.
Technical file (Simple copy)
Literature review and supporting documents
3.
Medical device/ In vitro diagnostics sample
4.
TMDA receipt (original)
5.
Cover letter (original)
Items found in the technical file-Class A
1.
Label of medical device (original)
2.
Instructions for use (original)
3.
Patient information leaflet (original)
4.
Sterilization validation report (original)
5.
Certification on IVDD methodology (original)
6.
Certification of electrical safety standards (original)
1.
Description of the medical device (original)
2.
Description of the features of the medical devices (original)
3.
List and summary of the countries (original)
4.
Risk assessment comprising an analysis and evaluation of risk (original)
5.
Specification of the materials used (original)
Waiting time in queue:
Min. 5mn
- Max. 10mn
Attention at counter:
Min. 5mn
- Max. 10mn
Waiting time until next step:
Min. 200 days
- Max. 240 days
1.
The Tanzania Food, Drugs and Cosmetics Act, 2003
Sections 52, 53
2.
Tanzania Food, Drug and Cosmetics (Control of Medical Device) Regulations, 2015
Sections 6, 7, 10
3.
Guideline on submission of documentation for registration of medical and in vitro diagostic device
Section 2
Additional information
The trader will be receiving regular notification on the update of the submission
Who certified this information ?
Damas NYANG'ANYI, Ag. Director of Business Support,
18/12/2018