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Steps (3) arrow_drop_up arrow_drop_down
Register a medical product  (3) expand_more expand_less

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Summary of the procedure

Institutions involved 2 expand_more expand_less

Bank of Kigali
Rwanda Food and Drugs Authority (x 2)

Results 1 expand_more expand_less

Certificate of medical product registration

Required Documents expand_more expand_less

Payment slip
Payment receipt
Application letter - med registration
Application form - med registration
Certificate of analysis (laboratory analysis results)

Estimated cost RWF  400,000

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RWF expand_more expand_less
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Cost detail

Estimate your cost

RWF 400,000
registration fee for human medicine

Total Duration 181d - 276d  expand_more expand_less

  Min. Max.
Total time (sum): 181d 276d
of which:
Waiting time in queue (sum): 0mn 50mn
Attention at counter: 20mn 1h.
Waiting time until next step (sum): 180d 275d

Laws 5 expand_more expand_less

Guidelines on submission of documentation for registration of human medicinal products FDA Guidelines on submission of documentation for registration of human medicinal products annex III-X
FDA Notice to the public - 20 March 2020 FDA Notice to the public - 20 March 2020
FDA Regulation Governing Registration of Medicinal Products FDA Regulation governing registration of medicinal products
  articles 1-14, 14-18
FDA Regulation governing service fees, tariff and fines FDA Regulation governing service fees, tariff and fines annex I
Law nº 003/2018 of 09/02/2018 establishing Rwanda Food and Drugs Authority and determining its mission, organisation and functioning Law nº 003/2018 of 09/02/2018 establishing Rwanda Food and Drugs Authority and determining its mission, organisation and functioning
  articles 3, 8, 9
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