1. IMPORT
  2. Commodities
  3. Medical device or in vitro diagnostic devices
  4. Initial registration and licences
  5. Registration of medical device or in vitro diagnostic devices
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Properties

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

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Summary of the procedure

Institutions involved 2 expand_more expand_less

Tanzania Food and Drugs Authority (TFDA), Sub- Head Office (x 5)
1 3 4 5 6
Bank
2

Results 1 expand_more expand_less

Medical device certificate of registration
6

Required Documents expand_more expand_less

Application form for registration of medical devices (x 2)
1 4
Technical file (x 2)
1 4
Cover letter (x 2)
1 4
Label of medical device (x 2)
1 4
The instruction for use (x 2)
1 4
The patient information leaflet (x 2)
1 4
Sterilization validation report (x 2)
1 4
Certification on IVDD methodology (x 2)
1 4
Certification of electrical safety standards
1
Description of the medical device (x 2)
1 4
Description of the features of the medical devices (x 2)
1 4
List and summary of the countries (x 2)
1 4
Risk assessment comprising an analysis and evaluation of risk (x 2)
1 4
Specification of the material used (x 2)
1 4
TFDA profoma invoice
2
Stamped bank deposit slip
3
TFDA receipt (x 2)
4 6

Estimated cost  USD  12,580

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USD expand_more expand_less
  • USD Add Name Here
USD 500
For medical device Class A non-exempted from registration
USD 2,500
For medical devices class B, C and D
USD 150
Variation-minor
USD 300
Variation-major
USD 200
Retention- Class A
USD 200
Class B, C and C
USD 100
Duplicate certificate
USD 350
Class A
USD 1,250
Class B
USD 1,500
Class C
USD 2,000
Class D
USD 125
Variation-minor
USD 250
Variation-major
USD 250
Retention
USD 100
Duplicate certificate
USD 75
class B
USD 250
Class C,D
USD 75
Class B
USD 250
Class B and D
USD 50
Variation- minor
USD 75
Variation-major
USD 100
Retention
USD 25
Export certificate
USD 30
Duplicate certificate
USD 125
Class A
USD 250
Class B
USD 375
Class C
USD 400
Class D
USD 125
Variation-minor
USD 250
Variation-major
USD 250
Retetion
USD 100
Duplicate certificate

Total Duration 220 d - 241 d expand_more expand_less

  Min. Max.
Total time (sum): 220 d 241 d
of which:
Waiting time in queue (sum): 30mn 55mn
Attention at counter: 25mn 1h.
Waiting time until next step (sum): 220 d 240 d

Laws 5 expand_more expand_less

Guidelines on Submission of Documentation for Registration of In Vitro Diagnostics Devices May, 2018 Guidelines on Submission of Documentation for Registration of In Vitro Diagnostics Devices May, 2018
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, 7 and 10, 14
TFDA fee and charges regulation Tanzania Food, Drugs and Cosmetics (Fee and Charges) Regulations, 2015
  Section  122 (1) (i)) schedule 42- 80
THE TANZANIA FOOD, DRUGS AND COSMETICS ACT, CAP 219, 2003 The Tanzania Food, Drugs and Cosmetics Act, 2003
  Sections 28, 52, 53
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