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Properties

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

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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)
TMDA profoma invoice
Stamped bank deposit slip
TMDA receipt (x 2)

Estimated cost USD  75

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TZS expand_more expand_less
  • TZS Add Name Here
USD 75
Registration fee for class B

Total Duration 221d - 271d  expand_more expand_less

  Min. Max.
Total time (sum): 221d 271d
of which:
Waiting time in queue (sum): 20mn 55mn
Attention at counter: 25mn 55mn
Waiting time until next step (sum): 220d 270d

Laws 5 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
GUIDELINES ON SUBMISSION OF DOCUMENTATION FOR REGISTRATION OF MEDICAL DEVICES Guidelines on Submission of Documentation for Registration of Medical Devices
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, 14, 17
TFDA fee and charges regulation Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 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
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