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Properties

Steps (5) arrow_drop_up arrow_drop_down
Obtain medical device or in vitro diagnostics import permit  (5) 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 3)
Bank

Results 1 expand_more expand_less

Permision to import medical devices

Required Documents expand_more expand_less

Customer registration form
Registration certificate of premise (x 2)
Medical device certificate of registration
Proforma invoice
Certificate of analysis of products
Certificate of origin
Bill of lading
Declaration of conformity of the device from the manufacturer
Certificate of conformity of the manufacturer to ISO 13485
TFDA profoma invoice
Stamped bank deposit slip
TFDA receipt

Cost expand_more expand_less

Cost detail

Estimate your cost

USD 0 -
2 % goods-value
of FOB value of the consignment
Fee for Import Permit

Total Duration 1 d - 1 d expand_more expand_less

  Min. Max.
Total time (sum): 1 d 1 d
of which:
Waiting time in queue (sum): 0mn 20mn
Attention at counter: 20mn 50mn
Waiting time until next step (sum): 0 d 1 d

Laws 4 expand_more expand_less

Guidelines for importation and exportation of medical devices including in vitro diagnostics Guidelines for importation and exportation of medical devices including in vitro diagnostics
Tanzania Food, Drug and Cosmetics (Control of Medicine Device) regulation 2015 Tanzania Food, Drug and Cosmetics (Control of Medical Device) Regulations, 2015
  Sections 46, 47
TFDA fee and charges regulation Tanzania Food, Drugs and Cosmetics (Fee and Charges) Regulations, 2015
  Section  51
THE TANZANIA FOOD, DRUGS AND COSMETICS ACT, CAP 219, 2003 The Tanzania Food, Drugs and Cosmetics Act, 2003
  Sections 20, 46
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