(Total Views: 367)
Posted On: 11/25/2020 7:24:47 PM
Post# of 8402
Re: NOTsteve34 #2824
MDSAP is currently only being used by 5 Countries:
USA
Australia
Japan
Canada
Brazil
The way I understand it the 'Medical Device Single Audit Program' certifies 'Quality Management Systems' for a manufacturer from all countries who sign onto MDSAP.
MDSAP is not involved in the actual approval of a Medical Device to be Safe and Effective for a specific medical condition.
None of the countries in Mundipharma's latest Distribution expansion, Philippines, Thailand, Singapore, Indonesia, Malaysia are a part of MDSAP.
USA
Australia
Japan
Canada
Brazil
The way I understand it the 'Medical Device Single Audit Program' certifies 'Quality Management Systems' for a manufacturer from all countries who sign onto MDSAP.
MDSAP is not involved in the actual approval of a Medical Device to be Safe and Effective for a specific medical condition.
None of the countries in Mundipharma's latest Distribution expansion, Philippines, Thailand, Singapore, Indonesia, Malaysia are a part of MDSAP.
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