MDSAP (medical device single audit program) is an international program, which allows a single regulatory audit of medical device manufacturer’s QMS’ for the following regulatory agencies:
• Therapeutics goods Administration (TGA) – Australia
• Agência Nacional de Vigilância Sanitária (Anvisa) – Brazil
• Health Canada (HC) – Canada
• Food and Drug Administration (FDA) – US
• Ministry of Health and Labour and Welfare (MHLW) – Japan
The benefit of MDSAP, is one single quality system inspection that will encompass 5 markets versus having to complete 5 separate audits. One single audit report will be shared among all the 5 regulatory agencies and will be accepted by the FDA and substituted for routine FDA inspections. MDSAP uses ISO 13485 as the underlying standard, however it will not replace ISO certification. Canada is the only Regulatory body that will require the MDSAP Audit for licensing/registration, all other countries recommend MDSAP in lieu of their own inspection.
MDSAP Companion Document
The Companion Document is the most critical component of MDSAP, this outlines the audit tasks to be carried out by the auditor, linkages between the various QMS process and the country specific requirements. It is critical that the medical device manufacturer is familiar with the companion document and has addressed all requirements in the QMS.
MDSAP audits are process based audits and focus on the following seven processes; 1. Management, 2. Measurement, analysis and improvement, 3. Design and development, 4. Production and service controls, 5. Purchasing, 6. Device marketing authorisation and facility registration, 7. Medical devices events and advisory notices reporting
MDSAP auditors will assess risk management activities during the audit of the QMS process. Risk management is an integral aspect of an organisation’s QMS and it is the responsibility of top management to provide the necessary commitment and resources for risk management.
Nonconformities are graded based on the degree of impact on the QMS and frequency of occurrence. If a medical device manufacturer receives a high-grade nonconformity, this may trigger an unannounced audit.
MDSAP Audit Cycle
There is a 3-year certification cycle, with surveillance audits conducted annually. Unlike ISO 13485 the audit time is based on tasks and not the employee count. As part of MDSAP all regulatory agencies review the report.
MDSAP will be fully implemented by 2019 and the biggest benefit for medical device manufacturers is, it will allow medical device manufacturers to sell in the 5 participant countries on the basis of one QMS audit. It is essential that medical device manufacturers are familiar with the MDSAP requirements outlined in the Companion document. In order to achieve compliance with the MDSAP requirements, it is necessary to carry out a MDSAP gap analysis against the requirements in the companion document, KD&A can help your organisation by performing gap analysis and help with the implementation of any specific requirements.
June 27, 2019