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Steps (37) arrow_drop_up arrow_drop_down
Obtain registration certificate of premises for medical and in vitro diagnostic devices  (5) expand_more expand_less
Obtain medical device or in vitro diagnostic registration certificate  (6) expand_more expand_less
Pre-clearance documentation  (3) expand_more expand_less
Obtain medical device or in vitro diagnostics import permit  (5) expand_more expand_less
Custom declaration  (3) expand_more expand_less
Verification of consignment  (3) expand_more expand_less
Obtain TRA release order  (2) expand_more expand_less
Obtain delivery order  (3) expand_more expand_less
Port clearance  (7) expand_more expand_less

9
Submit technical file (dossier)
(last modified: 03/03/2020)

Timeframe ( see details )

Wait until next step

10 mn  -  20 mn
200 days  -  210 days

Contact details

Entity in charge

Tanzania Medicines and Medical Devices Authority (TMDA), Sub- Head Office

Off Mandela Road, Mabibo - External , Dar es Salaam P.O. Box 77150, Dar Es Salaam
Tel: +255 222 450 512 / +255 222 450 751 / +255 800 110 084
Fax: +255 222 450 793
Email: tmda.go.tz, info@tmda.go.tz
Website: https://www.tmda.go.tz/
Directions: Google maps

Unit in charge

Medicines, cosmetics and medical devices registration customer window.

Mon: 08:30 - 13:00, 14:00 - 17:00
Tue: 08:30 - 13:00, 14:00 - 17:00
Wed: 08:30 - 13:00, 14:00 - 17:00
Thu: 08:30 - 13:00, 14:00 - 17:00
Fri: 08:30 - 13:00, 14:00 - 17:00
The office is closed during weekend and public holiday.

Person in charge

Prosper Mwandepa

Data entry technician
Tel: +255 699 707 774
Email: mis@tfda.go.tz

Expected results

Appointment

Requirements

1. Application form for registration of medical devices
Application form for registration of medical devices
or Application form for registration of in vitro diagnostics devices
Application form for registration of in vitro diagnostics devices (original)
2. 01 - Libre deuda de patente
Cover letter (original)
Addressed to the Director General.
3. 01 - Libre deuda de patente
TMDA receipt (original)
4. 01 - Libre deuda de patente
Technical file (original)
5. 01 - Libre deuda de patente
Medical device/ In vitro diagnostics sample
Items found in the technical file-Class A
1. 01 - Libre deuda de patente
Label of medical device (original)
2. 01 - Libre deuda de patente
Instructions for use (original)
3. 01 - Libre deuda de patente
Patient information leaflet (original)
4. 01 - Libre deuda de patente
Sterilization validation report (original)
5.
Certification on IVDD methodology (original)
For class B,C,D
1. 01 - Libre deuda de patente
Description of the medical device (original)
2. 01 - Libre deuda de patente
Description of the features of the medical devices (original)
3. 01 - Libre deuda de patente
List and summary of the countries (original)
4. 01 - Libre deuda de patente
Risk assessment comprising an analysis and evaluation of risk (original)
5. 01 - Libre deuda de patente
Specification of the materials used (original)

Time frame

Waiting time in queue: Min.   5mn - Max.  10mn
Attention at counter: Min.   5mn - Max.   10mn
Waiting time until next step: Min.   200 days - Max.   210 days

Legal justification

1. Tanzania Food, Drug and Cosmetics (Control of Medical Device) Regulations, 2015
Tanzania Food, Drug and Cosmetics (Control of Medical Device) Regulations, 2015
Section 7
2. The Tanzania Food, Drugs and Cosmetics Act, 2003
The Tanzania Food, Drugs and Cosmetics Act, 2003
Section 28

Additional information

The trader will be receiving regular notification on the update of the submission

Recourse: Tanzania Medicines and Medical Devices Authority (TMDA), Sub- Head Office

Entity in charge

Tanzania Medicines and Medical Devices Authority (TMDA), Sub- Head Office

Off Mandela Road, Mabibo - External , Dar es Salaam P.O. Box 77150, Dar Es Salaam
Tel: +255 222 450 512 / +255 222 450 751 / +255 800 110 084
Fax: +255 222 450 793
Email: tmda.go.tz, info@tmda.go.tz
Website: https://www.tmda.go.tz/
Directions: Google maps

Unit in charge

Communication and Public Education Section

Mon: 08:30 - 13:00, 14:00 - 17:00
Tue: 08:30 - 13:00, 14:00 - 17:00
Wed: 08:30 - 13:00, 14:00 - 17:00
Thu: 08:30 - 13:00, 14:00 - 17:00
Fri: 08:30 - 13:00, 14:00 - 17:00
The office is closed during weekend and public holiday.

Person in charge

Gaudensia Simwanza

Manager, Communication and public Education
Tel: +255 713616 263
Email: info@tfda.go.tz, gaudencia.simwanza@tfda.go.tz
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