TANZANIA INVESTMENT AND SPECIAL ECONOMIC ZONES AUTHORITY


Food and Drugs license from TFDA / Registration of Food, Drugs, Cosmetics and Devices / Register medical devices

Summary of the procedure

List of steps

List of steps (4)
1
Submit application for registraction of devices
2
Pay device registration fee
3
Obtain TMDA receipt
4
Obtain device registration certificate
 

Where to go?

Tanzania Medicines and Medical Devices Authority (TMDA) HQ (x 3)
1 3 4
Tanzania Medicines and Medical Devices Authority (TMDA) HQ
National Microfinance Bank (NMB)
2
National Microfinance Bank (NMB)

What you will get

Device registration certificate
4

Required documents

Device registration application form
1
NMB Bank slip
3
NMB Bank slip
TFDA receipt
4
TFDA receipt

How much?

Estimated minimum cost of the procedure : TZS  1,300,000 + USD 50
TZS  600,000 (  Registration fee for class D devices )
TZS  400,000 (  Registration fees for class B devices)
TZS  300,000 (  Registration fee for class B devices )
USD  50 (  Application fee for registration of class A medical devices)

How long ?

  min. max.
Total time (sum): 20mn 1h.
of which:
Waiting time in queue (sum): 0mn 20mn
Attention at counter: 20mn 40mn

Legal justification?

THE TANZANIA FOOD, DRUGS AND COSMETICS ACT, 2003  THE TANZANIA FOOD, DRUGS AND COSMETICS ACT, CAP 219, 2003
  ( Article S. 7 )

Detailed steps

1
Submit application for registraction of devices

Contact details

Entity in charge

Tanzania Medicines and Medical Devices Authority (TMDA) HQ

Off Mandela Road, Mabibo - External, Dar es Salaam P.o.Box: 77150
Tel: +255 22 2450512 / +255 22 2450751
Tel. 1: +255 22 2450793
Email: info@tmda.go.tz
Website: www.tfda.or.tz

Unit in charge

MEDICINES AND MEDICAL DEVICES REGISTRATION CUSTOMER WINDOW.

Mon: 08:30 - 01:00, 02:30 - 00:00
Tue: 08:30 - 01:00, 02:30 - 00:00
Wed: 08:30 - 01:00, 02:30 - 00:00
Thu: 08:30 - 01:00, 02:30 - 00:00
Fri: 08:30 - 01:00, 02:30 - 00:00

Person in charge

PROSPER MWANDEPA

Data entry technician
Tel: +255 699 707 774
Email: mis@tmda.go.tz

Expected results

1. 01 - TMDA proforma invoice
TMDA proforma invoice

Requirements

1.
Device registration application form (original)
2.
Device registration application form (soft copy)
3. 01 - Libre deuda de patente
Sample (devices)

Time frame

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

Legal justification

1. THE TANZANIA FOOD, DRUGS AND COSMETICS ACT, CAP 219, 2003
THE TANZANIA FOOD, DRUGS AND COSMETICS ACT, CAP 219, 2003

Recourse: Tanzania Medicines and Medical Devices Authority (TMDA) HQ

Entity in charge

Tanzania Medicines and Medical Devices Authority (TMDA) HQ

Off Mandela Road, Mabibo - External, Dar es Salaam P.o.Box: 77150
Tel: +255 22 2450512 / +255 22 2450751
Tel. 1: +255 22 2450793
Email: info@tmda.go.tz
Website: www.tfda.or.tz

Unit in charge

TMDA Customer Service

Mon: 08:30 - 01:00, 02:30 - 00:00
Tue: 08:30 - 01:00, 02:30 - 00:00
Wed: 08:30 - 01:00, 02:30 - 00:00
Thu: 08:30 - 01:00, 02:30 - 00:00
Fri: 08:30 - 01:00, 02:30 - 00:00

Person in charge

Roberta Feruzi

Customer Care Officer
Tel: +255 753649019
Email: mis@tfda.or.tz
2
Pay device registration fee

Contact details

Entity in charge

National Microfinance Bank (NMB)

Head Office Ohio/Ali Hassan Mwinyi Road, Dar es Salaam P.O Box 9213
Tel: Tel: +255222322000 / 0800 11 22 33
Tel. 1: Fax: +255222112148
Email: tuambie@nmbbank.co.tz
Website: www.nmbbank.co.tz

Unit in charge

NMB Customer Service

Mon: 08:30 - 03:30
Tue: 08:30 - 03:30
Wed: 08:30 - 03:30
Thu: 08:30 - 03:30
Fri: 08:30 - 03:30
Sat: 08:30 - 03:30
Sun: 08:30 - 03:30

Person in charge

NMB Teller

Teller

Expected results

1. 01 - NMB bank slip
NMB bank slip

Requirements

1.
TMDA Bank account number (NMB)
or
TMDA Bank account number (Citibank)

Cost TZS 1,300,000 + USD 50

TZS expand_more expand_less
  • TZS Add Name Here
Foreign medical devices
USD 50
Application fee for registration of class A medical devices
or  USD 500
Application fee for registration of class B devices
or  USD 750
Application fee for registration of class C devices
or  USD 1,000
Application fee for registration of class D of devices
Locally manufactured devices
TZS 300,000
Registration fee for class B devices
TZS 400,000
Registration fees for class B devices
TZS 600,000
Registration fee for class D devices

Time frame

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

Legal justification

1. THE TANZANIA FOOD, DRUGS AND COSMETICS ACT, CAP 219, 2003
THE TANZANIA FOOD, DRUGS AND COSMETICS ACT, CAP 219, 2003
Article S.7
3
Obtain TMDA receipt

Contact details

Entity in charge

Tanzania Medicines and Medical Devices Authority (TMDA) HQ

Off Mandela Road, Mabibo - External, Dar es Salaam P.o.Box: 77150
Tel: +255 22 2450512 / +255 22 2450751
Tel. 1: +255 22 2450793
Email: info@tmda.go.tz
Website: www.tfda.or.tz

Unit in charge

TMDA Accounts department

Mon: 08:30 - 01:00, 02:30 - 00:00
Tue: 08:30 - 01:00, 02:30 - 00:00
Wed: 08:30 - 01:00, 02:30 - 00:00
Thu: 08:30 - 01:00, 02:30 - 00:00
Fri: 08:30 - 01:00, 02:30 - 00:00

Person in charge

Noela Nyaitika

Cashier
Tel: +255 717913020
Email: nnyaitika@gmail.com

Expected results

1. 01 - TFDA receipt
TFDA receipt

Requirements

1. 01 - Libre deuda de patente
NMB Bank slip (original)

Time frame

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

Recourse: Tanzania Medicines and Medical Devices Authority (TMDA) HQ

Entity in charge

Tanzania Medicines and Medical Devices Authority (TMDA) HQ

Off Mandela Road, Mabibo - External, Dar es Salaam P.o.Box: 77150
Tel: +255 22 2450512 / +255 22 2450751
Tel. 1: +255 22 2450793
Email: info@tmda.go.tz
Website: www.tfda.or.tz

Unit in charge

TMDA Customer Service

Mon: 08:30 - 01:00, 02:30 - 00:00
Tue: 08:30 - 01:00, 02:30 - 00:00
Wed: 08:30 - 01:00, 02:30 - 00:00
Thu: 08:30 - 01:00, 02:30 - 00:00
Fri: 08:30 - 01:00, 02:30 - 00:00

Person in charge

Roberta Feruzi

Customer Care Officer
Tel: +255 753649019
Email: mis@tfda.or.tz
4
Obtain device registration certificate

Contact details

Entity in charge

Tanzania Medicines and Medical Devices Authority (TMDA) HQ

Off Mandela Road, Mabibo - External, Dar es Salaam P.o.Box: 77150
Tel: +255 22 2450512 / +255 22 2450751
Tel. 1: +255 22 2450793
Email: info@tmda.go.tz
Website: www.tfda.or.tz

Expected results

1. Device registration certificate
Device registration certificate

Requirements

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

Time frame

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

Recourse: Tanzania Medicines and Medical Devices Authority (TMDA) HQ

Entity in charge

Tanzania Medicines and Medical Devices Authority (TMDA) HQ

Off Mandela Road, Mabibo - External, Dar es Salaam P.o.Box: 77150
Tel: +255 22 2450512 / +255 22 2450751
Tel. 1: +255 22 2450793
Email: info@tmda.go.tz
Website: www.tfda.or.tz

Unit in charge

TMDA Customer Service

Mon: 08:30 - 01:00, 02:30 - 00:00
Tue: 08:30 - 01:00, 02:30 - 00:00
Wed: 08:30 - 01:00, 02:30 - 00:00
Thu: 08:30 - 01:00, 02:30 - 00:00
Fri: 08:30 - 01:00, 02:30 - 00:00

Person in charge

Roberta Feruzi

Customer Care Officer
Tel: +255 753649019
Email: mis@tfda.or.tz