What is the Medical Device Single Audit Program (MDSAP)?
The Medical Device Single Audit Program (MDSAP) was launched by the International Medical Device Regulators Forum (IMDRF) in 2014 as a pilot program, satisfying the requirements of the pilot program in December 2016. MDSAP allows a MDSAP recognized third party Auditing Organisation (AO) to conduct a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the relevant requirements of the regulatory authorities participating in the program. The use of third-party auditors allows government resources to focus on high risk medical devices and manufacturers that are not in compliance with the regulations whilst also keeping oversight of the third-party Auditing Organisations.
There are currently 14 Eligible Auditing Organisations authorised to conduct MDSAP Audits which are listed on the FDA website AO Availability To Conduct MDSAP Audits 2019-08-30
Who are the Participating Countries?
Four IMDRF members joined the pilot program in 2014 – Australia (TGA), Canada (Health Canada), The United States (FDA) and Brazil (ANVISA). Japan (PMDA and MHLW) joined as an Official Observer.
In 2015, Japan officially joined the MDSAP program on an annual basis in order to reduce the burden on the Japanese regulatory process. In 2019, Japan renewed its participation in MDSAP so that Japan’s Pharmaceutical and Medical Device Agency (PMDA) will continue to recognise MDSAP certifications for Quality Management System compliance until March 2020.
Participation in MDSAP is voluntary, with the exception of Canada.
As of 01 January 2019, any organisation wishing to sell medical devices in Canada must have a MDSAP Quality Management System certification. Health Canada received over 3000 MDSAP certificates or transition submissions, representing over 90% of medical device manufacturers. Health Canada continues to support the transition to MDSAP to ensure Canadians have access to safe and effective medical devices. Health Canada has engaged and continues to engage with the MDSAP Consortium to identify opportunities to reduce audit times and improve efficiencies.
For example, Manufacturers could benefit from reductions in audit duration if they meet the following criteria:
- Have 100 or fewer employees
- Make only lower risk products (Class II medical devices)
- Use simple design and manufacturing process using commonly available materials and established technologies
- Have a good history of conformity to ISO 13485 and regulatory requirements.
Official Observers: The European Union (EU) and the World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Program are Official Observers of the MDSAP program.
What are the differences between MDSAP and ISO 13585:2016?
MDSAP is aligned with ISO 13485:2016, however the key differences include:
- Country specific regulatory requirements are included in the MDSAP audit.
- Grading system for Non-Conformities is a point-based system based on QMS Impact (Direct and Indirect) and Occurrence which is aligned with the Global Harmonization Task Force Quality Management System – Medical Devices – Nonconformity Grading System for Regulatory Purposes and Information Exchange.
- There are two Stages in the initial assessment (Stage 1: Documentation Review, Stage 2: On-Site Assessment)
- Documentation Differences (Pre-Market Regulatory, Post-Market Regulatory, Recalls and Product Notifications, Design and Development, Design Changes)
What are the benefits of MDSAP?
During a MDSAP audit, country specific regulatory requirements are included in the scope of the audit. Regulators included in the IMDRF will use the MDSAP audit report to substitute for the evidence of manufacturer’s QMS certifications. These countries will not require additional country-specific audits.
- Canada: MDSAP Audit Certificates replace CMDCAS certificates (key change)
- US: MDSAP audit reports are acceptable as a substitute for FDA routine inspections. This does not include other inspections such as For Cause, Pre/ Post approval, Compliance Follow ups and Compliance with Electronic Product Radiation Control (EPRC) Regulations)
- Australia: MDSAP audit reports will be used to evaluate compliance in support of market authorisation requirements.
- Brazil: MDSAP Audit Certificates replace Brazilian GMP Certificates.
- Japan: PMDA accepts MDSAP audit reports to reduce burden to medical device manufacturers. PMDA may perform off-site inspection instead of on-site inspection.
What is the MDSAP Audit Process?
There are 7 MDSAP Auditing Processes. There are four primary processes and three supporting processes each with documentation requirements.
- Management (Primary Process)
- Device Marketing Authorization and Facility Registration (Supporting Process)
- Measurement, Analysis and Improvement (Primary Process)
- Medical Device Adverse Events and Advisory Notices Reporting (Supporting Process)
- Design and Development (Primary Process)
- Production and Service Controls (Primary Process)
- Purchasing (Supporting Process)
The take up of MDSAP is growing exponentially. Please contact PharmOut for external audit support to ensure your organisation is MDSAP ready.