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Preview & Print

Properties

Steps (3) arrow_drop_up arrow_drop_down
Obtain medical device listing  (3) expand_more expand_less

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Summary of the procedure

Institutions involved 2 expand_more expand_less

Pharmacy and Poisons Board (PPB) Trade Portal (x 2)
Pharmacy and Poisons Board (PPB)

Results 1 expand_more expand_less

Medical device listing

Required Documents expand_more expand_less

ISO 13485:2016 certificate
Pre - market approval
Certificate of free sale
Certificate of analysis
Pre - verification certificate
Product packaging
Instructions for use
Pharmacy and Poisons Board (PPB) invoice

Estimated cost USD  1,000

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KES expand_more expand_less
  • KES Add Name Here

Cost detail

Estimate your cost

USD 1,000
For medical device emergency authorization.

Total Duration 15mn - 3d   expand_more expand_less

  Min. Max.
Total time (sum): 15mn 3d
of which:
Waiting time in queue (sum): 5mn 30mn
Attention at counter: 10mn 5h. 20mn
Waiting time until next step (sum): 0mn 2d

Laws 1 expand_more expand_less

Health Act 2017 Health Act 2017
  Sections 62, 63 ,  articles 62, 63
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