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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

11
Obtain medical device or in vitro diagnostics registration certificate
(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

Director of Medicine, Cosmetics and Food safety (2nd floor)

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

Joyce Komba

Office management secretary
Tel: +255 699 707 774
Email: joyce.komba@tfda.go.tz

Expected results

Medical device certificate of registration

Requirements

1. 01 - Libre deuda de patente
TMDA receipt (original)

Time frame

Waiting time in queue: Min.   15mn - Max.  20mn
Attention at counter: Min.   5mn - Max.   15mn

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 14

Additional information

The registration of medical device is valid for five (5) years subject to payment of annual retention fee

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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