MDSAP is currently only being used by 5 Countries:
Post# of 7755
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.