The FDA published a revised MDSAP AUDIT APPROACH (MDSAP AU P0002.009) on August 6, 2024.
The revision from MDSAP AU P0002.008 to 009 is briefly as follows.
1. Australia (TGA)
As a result of changes to the Guidance for Australia (TGA) country-specific requirements, the following items have been revised or removed from the TGA requirements.
1) Management - Task 5 & Task 8
2) Device Marketing Authorization and Facility Registration – Task 1, Task 2 & Task 3
3) Measurement, Analysis and Improvement – Task 7 & Task 12
4) Medical Device Adverse Events and Advisory Notices Reporting – Task 1 & Task 2
5) Purchasing – Task 5
6) Annex 4
The responsibility for ensuring compliance with some applicable regulatory requirements for medical devices is specifically imposed on the Australian Sponsor by the TGA. (ISO13485:2016 Cl 3.10 – Note 1)
Consequently, these requirements are not auditable under the MDSAP unless they are identified, in whole or in part, as customer requirements.
2. Japan (MHLW)
Removed references to MHLW MO169 harmonized to ISO 13485:2003 throughout the document.
3. USA (FDA)
Removed colored boxes and colored font throughout to comply with U.S. requirements for Section 508 of the 1998 amendment to the Rehabilitation Act of 1973.
Please refer to the attached file below for more information.
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