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Preview & Print


Preview & Print


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/Systems 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
Certificate of free sale
Regulatory approval certificate
Certificate of analysis
Pre - verification certificate
Product packaging
Instructions for use
Pharmacy and Poisons Board (PPB) invoice


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Cost detail

Estimate your cost

USD 0 -
USD  100 per manufacturing site per year
For medical device registration.

Total Duration 15mn - 181d  expand_more expand_less

  Min. Max.
Total time (sum): 15mn 181d
of which:
Waiting time in queue (sum): 5mn 30mn
Attention at counter: 10mn 5h. 20mn
Waiting time until next step (sum): 0mn 180d

Laws 1 expand_more expand_less

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