PMCF (Post Market Clinical Follow-Up) is maybe one of the most challenging
MEDICAL DEVICE SINGLE AUDIT PROGRAM
The Medical Device Single Audit Program (MDSAP) is led by Australian TGA, Brazilian ANVISA, Health Canada, US FDA and Japanese MHLW to implement a program where Auditing Organizations (AO) can conduct a single audit of a medical device manufacturer’s quality management system that will satisfy the requirements of the medical device regulatory authorities participating in the MDSAP.
Audits performed under the MDSAP program will be process based, focusing on several defined processes, a defined method for linking those processes, and built on a foundation of requirements for risk management.
The MDSAP audit sequence is designed and developed to allow for the audit to be conducted in a logical, focused, and efficient manner and has been based on five processes. Four of which have been called as primary processes are;
- Measurement, Analysis and Improvement;
- Design and Development;
- Production and Service Controls;
And the fifth process (5) Purchasing is called a supporting process.
The definition of each process includes a purpose and an outcome that are indicators of process performance. These five processes are built on a foundation of requirements for risk management and comprise the requirements of a quality management system for medical device manufacturers according to ISO 13485:2016, the Quality Management System requirements of the Conformity Assessment Procedures of the Australian Therapeutic Goods (Medical Devices) Regulations (TG(MD)R Sch3), Brazilian Good Manufacturing Practices (RDC ANVISA16/2013), Japan Ordinance on Standards for Manufacturing Control and Quality Control of Medical Devices and In Vitro Diagnostic Reagents (MHLW Ministerial Ordinance No. 169), and the Quality System Regulation (21 CFR Part 820).
Five of the RAs (Australian TGA, Brazilian ANVISA, Health Canada, US FDA and Japanese MHLW) have been running a three year MDSAP pilot. Health Canada has announced that as of 1 January 2019, they will terminate their current CMDCAS program and only accept MDSAP certificates.
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