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Steps (6) arrow_drop_up arrow_drop_down
Obtain medical device or in vitro diagnostic devices registration certificate  (6) expand_more expand_less

certification bar

4
Submit technical file (dossier)
(last modified: 09/09/2020)

Timeframe ( see details )

Wait until next step

10 mn  -  20 mn
200 days  -  240 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
The office is closed during weekend and public holiday.

Unit in charge

Medicines 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 (original)
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
Technical file (Simple copy)
Literature review and supporting documents
3. 01 - Libre deuda de patente
Medical device/ In vitro diagnostics sample
4. 01 - Libre deuda de patente
TMDA receipt (original)
5. 01 - Libre deuda de patente
Cover letter (original)
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)
6. 01 - Libre deuda de patente
Certification of electrical safety standards (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.   240 days

Legal justification

1. The Tanzania Food, Drugs and Cosmetics Act, 2003
The Tanzania Food, Drugs and Cosmetics Act, 2003
Sections 52, 53
2. Tanzania Food, Drug and Cosmetics (Control of Medical Device) Regulations, 2015
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
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

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
The office is closed during weekend and public holiday.

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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