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Steps (3) arrow_drop_up arrow_drop_down
Register a medical device  (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 receipt
Application letter - medical device
Application form - med registration
Certificate of analysis (laboratory analysis results)

Estimated cost RWF  100,000

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RWF expand_more expand_less
  • RWF Add Name Here
RWF 100,000
Class A

Total Duration 91d - 276d  expand_more expand_less

  Min. Max.
Total time (sum): 91d 276d
of which:
Waiting time in queue (sum): 0mn 50mn
Attention at counter: 20mn 1h.
Waiting time until next step (sum): 90d 275d

Laws 6 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
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
  Article 14-18
FDA Regulation governing service fees, tariff and fines FDA Regulation governing service fees, tariff and fines annex I
Guidelines on submission of documentation for registration of medical devices Guidelines on submission of documentation for registration of medical devices
  articles 1.4, 1.6
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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