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Obtain registration certificate of premises for medical and in vitro diagnostic devices  (5) expand_more expand_less

certification bar

1
Submit application for premise registration
(last modified: 09/11/2021)

Timeframe ( see details )

Wait until next step

10 mn  -  20 mn
 -  0.5 day

Contact details

Entity in charge

Tanzania Medicines and Medical Devices Authority

Ally Hassan Mwinyi road, Victoria GEPF house Box 31356, Dar es Salaam
Tel: +255 788 470 312
Website: https://www.tmda.go.tz/
The office is closed during weekend and public holiday.

Unit in charge

Customer Service and Compliance Desk

Mon: 07:30 - 15:30
Tue: 07:30 - 15:30
Wed: 07:30 - 15:30
Thu: 07:30 - 15:30
Fri: 07:30 - 15:30
The office is closed during weekend and public holiday.

Person in charge

Nancy Mwimbwa

Assistant information and education officer
Tel: +255 788 470 312
Email: nancy.mwimbwa@tfda.go.tz
TFDA zonal office TFDA zonal office

Expected results

TMDA profoma invoice

Requirements

1. Application form for medical device premise registration
Application form for medical device premise registration (original)
2. Application form for licence
Application form for licence (original)
3. 01 - Libre deuda de patente
Tax Identification Number certificate (Simple copy)
For registered company or business name
4. 01 - Libre deuda de patente
Memorandum and articles of association (Simple copy)
5. 01 - Libre deuda de patente
Certificate of incorporation (Simple copy)
For companies which are incorporated in Tanzania.
or 01 - Libre deuda de patente
Business registration certificate (Simple copy)
For registered business name
or 01 - Libre deuda de patente
Certificate of compliance (Simple copy)
For foreign companies (companies are incorporated outside Tanzania mainland and they come in the country as branches of such foreign companies.)
6. 01 - Libre deuda de patente
Academic certificate (Simple copy)
Should be a health related certificate, certified by the supervisor
7. 01 - Libre deuda de patente
Commitment letter (Simple copy)
Addressed to the Director General
8. 01 - Libre deuda de patente
Sketch location of the premise (Simple copy)

Time frame

Waiting time in queue: Min.   5mn - Max.  10mn
Attention at counter: Min.   5mn - Max.   10mn
Waiting time until next step: Max.   0.5 day

Legal justification

1. The Tanzania Food, Drugs and Cosmetics Act, 2003
The Tanzania Food, Drugs and Cosmetics Act, 2003
Sections 18, 20
2. Tanzania Food, Drug and Cosmetics (Control of Medical Device) Regulations, 2015
Tanzania Food, Drug and Cosmetics (Control of Medical Device) Regulations, 2015
Sections 24, 31

Additional information

Applications for registration of premises can be made at any Tanzania Medicines and Medical devices Authority zone offices.

Who certified this information ?

Damas NYANG'ANYI, Ag. Director of Business Support, 18/12/2018

Recourse: Tanzania Medicines and Medical Devices Authority

Entity in charge

Tanzania Medicines and Medical Devices Authority

Ally Hassan Mwinyi road, Victoria GEPF house Box 31356, Dar es Salaam
Tel: +255 788 470 312
Website: https://www.tmda.go.tz/
The office is closed during weekend and public holiday.

Unit in charge

Customer Service and Compliance Desk

Mon: 07:30 - 15:30
Tue: 07:30 - 15:30
Wed: 07:30 - 15:30
Thu: 07:30 - 15:30
Fri: 07:30 - 15:30
The office is closed during weekend and public holiday.

Person in charge

Emmanuel Alphonce

Manager, Eastern zone
Tel: +255 754 284 367
Email: emmanuel.alphonce@tfda.go.tz
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