MDSAP Certification: Single Audit Program for Medical Devices

What is MDSAP certification?

The Medical Device Single Audit Program (MDSAP) is a recognised scheme that allows a single regulatory audit of a medical device manufacturer's quality management system to satisfy the requirements of multiple jurisdictions. In practice, one MDSAP audit covers the regulatory authorities of Australia (TGA), Brazil (ANVISA), Canada (Health Canada), Japan (MHLW/PMDA), and the United States (FDA). For device makers exporting to several of these markets, MDSAP replaces repeated country-by-country inspections with one combined audit programme.

How to obtain MDSAP certification

The MDSAP certification process for medical device manufacturers includes the following stages:

• Application: the manufacturer applies to an MDSAP-authorised auditing organisation, listing product types, intended use, and manufacturing processes.
• Audit: the auditing organisation evaluates production and quality-system processes against MDSAP requirements and the regulations of the participating authorities.
• Reporting and follow-up: audit findings are documented and presented to the manufacturer, who then closes out any nonconformities through corrective action.
• Certification: once the audit is successfully completed and findings are cleared, the MDSAP certificate is issued, supporting access to multiple regulated markets.
• Surveillance: certificate holders are audited on an ongoing cycle to maintain validity and the certificate is renewed on schedule.

Products covered

MDSAP applies to medical device manufacturers whose quality management system falls within the scope of ISO 13485 and the regulatory requirements of the participating authorities. This covers a broad range of device classes, from general medical equipment to higher-risk implants and in vitro diagnostics, where placement on any of the five participating markets is planned.

MDSAP certification pricing

MDSAP pricing varies with the number of sites, the number and class of device families, and the complexity of the quality system. Contact Sistem Patent Kalite for a quotation tailored to your scope.

Why work with Sistem Patent Kalite

For medical device manufacturers pursuing MDSAP, Sistem Patent Kalite offers practical support:

• Sector experience: we work regularly with medical device quality and regulatory teams and understand the documentation MDSAP auditors expect.
• Project-specific approach: we plan the programme around your device families, sites, and target markets rather than applying a generic checklist.
• Process management: we coordinate timelines with the auditing organisation so the certificate issues without avoidable delays.
• Clear pricing: we quote in writing and keep the commercial side predictable for the finance team.
• Ongoing support: MDSAP is a multi-year commitment and we stay with clients through surveillance audits and recertification.

MDSAP is an important certification for medical device manufacturers competing in regulated global markets. It verifies safety and quality and simplifies international acceptance. Sistem Patent Kalite supports manufacturers at each stage of the programme.

Contact us for detailed information or to begin the application. For a reliable partner in international medical device certification, Sistem Patent Kalite is the right address.