print

Preview & Print

Properties

Preview & Print

Properties

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

arrow_drop_up arrow_drop_down
Summary of the procedure

Institutions involved 2 expand_more expand_less

Tanzania Medicines and Medical Devices Authority (TMDA), Sub- Head Office (x 5)
Bank

Results 1 expand_more expand_less

Medical device certificate of registration

Required Documents expand_more expand_less

Application form for registration of medical devices (x 2)
Cover letter (x 2)
Technical file (x 2)
Label of medical device (x 2)
Instructions for use (x 2)
Patient information leaflet (x 2)
Sterilization validation report (x 2)
Certification on IVDD methodology (x 2)
Certification of electrical safety standards (x 2)
Description of the medical device (x 2)
Description of the features of the medical devices (x 2)
List and summary of the countries (x 2)
Risk assessment comprising an analysis and evaluation of risk (x 2)
Specification of the materials used (x 2)
TFDA profoma invoice
Stamped bank deposit slip
TFDA receipt (x 2)

Estimated cost  USD  925

expand_more expand_less

USD expand_more expand_less
  • USD Add Name Here
USD 500
Registration fee for medical device Class A
USD 75
Registration fee for class B
USD 350
Registration fee for class A

Total Duration 220 d - 271 d expand_more expand_less

  Min. Max.
Total time (sum): 220 d 271 d
of which:
Waiting time in queue (sum): 20mn 55mn
Attention at counter: 25mn 55mn
Waiting time until next step (sum): 220 d 270 d

Laws 4 expand_more expand_less

Guidline 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
Tanzania Food, Drug and Cosmetics (Control of Medicine Device) regulation 2015 Tanzania Food, Drug and Cosmetics (Control of Medical Device) Regulations, 2015
  Sections 6, 7, 10, 13
TFDA fee and charges regulation Tanzania Food, Drugs and Cosmetics (Fee and Charges) Regulations, 2015
  Article First schedule 42-80
THE TANZANIA FOOD, DRUGS AND COSMETICS ACT, CAP 219, 2003 The Tanzania Food, Drugs and Cosmetics Act, 2003
  Sections 52, 53
Powered by eRegulations ©, a content management system developed by UNCTAD's Business Facilitation Program and licensed under Creative Commons License