Preview & Print


Preview & Print


Steps (6) arrow_drop_up arrow_drop_down
Obtain registration certificate of premises for medical and in vitro diagnostic devices  (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) ( Eastern zone office) (x 5)

Results 2 expand_more expand_less

Registration certificate of premise
Business permit of a premise (TFDA)

Required Documents expand_more expand_less

Application form for medical device premise registration
Application form for licence
Tax Identification Number certificate
Memorandum and articles of association
Certificate of incorporation
Academic certificate
Commitment letter
Sketch location of the premise
TFDA profoma invoice
Stamped bank deposit slip
TFDA receipt

Estimated cost TZS  350,000

expand_more expand_less

USD expand_more expand_less
  • USD Add Name Here
TZS 300,000
Premise registration fee
TZS 50,000
Inspection fee.

Total Duration 8 d - 19 d expand_more expand_less

  Min. Max.
Total time (sum): 8 d 19 d
of which:
Waiting time in queue (sum): 30mn 1h.
Attention at counter: 40mn 1h. 25mn
Waiting time until next step (sum): 8 d 18 d

Laws 3 expand_more expand_less

Tanzania Food, Drug and Cosmetics (Control of Medicine Device) regulation 2015 Tanzania Food, Drug and Cosmetics (Control of Medical Device) Regulations, 2015
  Sections 14, 31 (2)
TFDA fee and charges regulation Tanzania Food, Drugs and Cosmetics (Fee and Charges) Regulations, 2015
  Sections 4, first schedule
THE TANZANIA FOOD, DRUGS AND COSMETICS ACT, CAP 219, 2003 The Tanzania Food, Drugs and Cosmetics Act, 2003
  Sections 5 (h), 18, 20
Powered by eRegulations ©, a content management system developed by UNCTAD's Business Facilitation Program and licensed under Creative Commons License