Welcome to Tanzania's Official Trade Portal More information
Official uses .go.tz

The Tanzania Trade Portal is managed by the Tanzania Trade Development Authority (TanTrade) under the auspices of the National Trade Facilitation Committee (NTFC)

Secure .go.tz website using HTTPS

A lock ( ) or https:// means you're safely connected to the .gov website.

Share sensitive information only on official, secure websites.

Summary print

Preview & Print

Properties

Steps (31) arrow_drop_up arrow_drop_down
Obtain registration certificate of premises for medical or in vitro diagnosis device  (5) expand_more expand_less
Obtain medical device or in vitro diagnostic devices registration certificate  (6) expand_more expand_less
Obtain medical device or in vitro diagnosis device export permit  (2) expand_more expand_less
Pre-clearance documentation  (2) expand_more expand_less
Custom declaration  (2) expand_more expand_less
Consignment inspection  (2) expand_more expand_less
Obtain TRA release order  (2) expand_more expand_less
Port clearance  (5) expand_more expand_less
Obtain EAC certificate of origin  (5) expand_more expand_less

certification bar

1
Register and apply for premise registration
(last modified: 17/01/2022)

You can apply for this step online

language Apply online

Contact details

Entity in charge

RIMS Customer Self Service Portal

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 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

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 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 of the Tanzania Medicine 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
Powered by eRegulations ©, a content management system developed by UNCTAD's Business Facilitation Program and licensed under Creative Commons License