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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

6
Obtain TFDA profoma invoice for medical device or in vitro diagnostic registration
(last modified: 03/03/2020)

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

TMDA profoma invoice.

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
Cover letter (original)
Addressed to Director General
3. 01 - Libre deuda de patente
Technical file (original)
4. 01 - Libre deuda de patente
Medical device/ In vitro diagnostics sample
If applicable
Items found in the technical file-Class A
1. 01 - Libre deuda de patente
Label of medical device (original)
For both primary and secondary components
2. 01 - Libre deuda de patente
Instructions for use (original)
3. 01 - Libre deuda de patente
Patient information leaflet (original)
Where applicable
4. 01 - Libre deuda de patente
Sterilization validation report (original)
For sterile medical device
5.
Certification on IVDD methodology (original)
For active medical device
6. 01 - Libre deuda de patente
Certification of electrical safety standards (original)
Items found in the technical file class B, C, D
1. 01 - Libre deuda de patente
Description of the medical device (original)
Materials used for manufacturing and packing
2. 01 - Libre deuda de patente
Description of the features of the medical devices (original)
Document describing the purposes and uses for which the medical device is manufactured, sold or represented.
3. 01 - Libre deuda de patente
List and summary of the countries (original)
That the device has been sold
4. 01 - Libre deuda de patente
Risk assessment comprising an analysis and evaluation of risk (original)
ISO 14971
5. 01 - Libre deuda de patente
Specification of the materials used (original)
In manufacturing and packaging

Time frame

Waiting time in queue: Min.   5mn - Max.  10mn
Attention at counter: Min.   5mn - Max.   10mn

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, 7and10
3. Guidelines on Submission of Documentation for Registration of Medical Devices
Guidelines on Submission of Documentation for Registration of Medical Devices
4. Guidelines on Submission of Documentation for Registration of In Vitro Diagnostics Devices May, 2018
Guidelines on Submission of Documentation for Registration of In Vitro Diagnostics Devices May, 2018

Additional information

At this step trader submit the technical file fo TFDA for review and given back to him.

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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