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

certification bar

1
Apply for medical device or in vitro diagnostic devices registration
(last modified: 15/11/2021)

You can apply for this step online

language Apply online

Contact details

Entity in charge

RIMS Customer Self Service Portal

Expected results

TMDA profoma invoice

Requirements

1. Application form for registration of medical devices
Application form for registration of medical devices (original)
or Application form for registration of in vitro diagnostics devices
Application form for registration of in vitro diagnostics devices (original)
2. 01 - Libre deuda de patente
Cover letter (original)
3. 01 - Libre deuda de patente
Technical file
Literature review and supporting documents
4. 01 - Libre deuda de patente
Medical device/ In vitro diagnostics sample
Items found in the technical file-Class A
1. 01 - Libre deuda de patente
Label of medical device (original)
for both primary and secondary components
2. 01 - Libre deuda de patente
Instructions for use (original)
3. 01 - Libre deuda de patente
Patient information leaflet (original)
where applicable
4. 01 - Libre deuda de patente
Sterilization validation report (original)
for sterile medical device
5.
Certification on IVDD methodology (original)
6. 01 - Libre deuda de patente
Certification of electrical safety standards (original)
For class B,C,D
1. 01 - Libre deuda de patente
Description of the medical device (original)
Material used and its manufacturing and packing
2. 01 - Libre deuda de patente
Description of the features of the medical devices (original)
Permit it to be used for the medical conditions, purposes and uses for which it is manufactured, sold or represented
3. 01 - Libre deuda de patente
List and summary of the countries (original)
That the device has been sold
4. 01 - Libre deuda de patente
Risk assessment comprising an analysis and evaluation of risk (original)
ISO 14971
5. 01 - Libre deuda de patente
Specification of the materials used (original)
in manufacture and packaging

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 52, 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 6, 7, 10
3. Guideline on submission of documentation for registration of medical and in vitro diagostic device
Guideline on submission of documentation for registration of medical and in vitro diagostic device
Section 2
4. Guidelines on Submission of Documentation for Registration of Medical Devices
Guidelines on Submission of Documentation for Registration of Medical Devices

Additional information

At this step trader submit the technical file fo TMDA for review and given back to him.

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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