The International Medical Device Regulators Forum (IMDRF) recognizes that a global approach to auditing and monitoring medical device developers and manufacturers could improve the devices’ safety and the regulators’ oversight on an international scale. Back in 2012, the IMDRF identified a work group to develop specific documents for advancing a Medical Device Single Audit Program (MDSAP).
The MDSAP Program allows an MDSAP recognized Auditing Organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program.
Gsap has led MDSAP readiness activities with its Medical Device customers. We have a professional and knowledgeable team to support you in defining and aligning your business regulatory and quality strategy in accordance with the new approach of the MDSAP.
International partners that are participating in the MDSAP:
• Australia’s Therapeutic Goods Administration (TGA)
• Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA)
• Health Canada – Santé Canada – MDSAP is mandatory from January 2019
• Japan’s Ministry of Health, Labour and Welfare (MHLW)
• USA – Food and Drug Administration (FDA)
MDSAP in General
• MDSAP covers regulatory aspects as well as:
o Registration
o Licensing
o Adverse event reporting
• MDSAP participating countries have direct access to the audit reports
• Audit is focused on requirements of ISO 13485:2016 and the regulatory requirements of the applicable jurisdictions (A manufacturer may exclude the requirements of a jurisdiction where the organization does not intend to supply medical devices)
• Audits conducted by approved Auditing Organizations (AO; Updated, official list is available at FDA site)
Preparation for the MDSAP
• Perform gap assessment for all procedures and processes
• Develop and implement risk assessment program
• Reach out to approved Auditing Organizations (AO)
• Fill AO’s questionnaire (to be used for additional assessment)
• Get a quote for services
• List products, registrations and licenses for applicable markets
• List types of products under the scope of the company
• Schedule an audit
• Be prepared for audits – # of days based on # of tasks to be audited
Gsap will be happy to support you in getting ready for the MDSAP requirements!
For more information visit Medical device Industry page
This Newsletter Prepared by:
Marina Lebel, B.Sc, CQE
VP Medical Device