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

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6
Obtain medical device or in vitro diagnostics devices registration certificate
(last modified: 09/09/2020)

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
The office is closed during weekend and public holiday.

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.   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
Section 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 14, 17

Additional information

The registration of medical device shall be valid for five (5) years subject to payment of annual retention fee as prescribed under the Fees and Charges Regulations made under the Act.

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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