MDSAP

The Medical Device Single Audit Program (MDSAP) is an international collaborative initiative that enables medical device manufacturers to undergo a single regulatory audit that satisfies the requirements of multiple regulatory authorities. Currently, five countries participate: United States (FDA), Canada (Health Canada), Brazil (ANVISA), Australia (TGA), and Japan (MHLW/PMDA).

How MDSAP works:
- A single audit conducted by an accredited MDSAP Auditing Organization
- Audit covers ISO 13485 requirements plus country-specific regulations
- Results recognized by all five participating regulatory authorities
- Reduces duplicate audits and streamlines compliance
- Certificates valid for 3 years with annual surveillance audits

MDSAP audit scope: MDSAP audits assess compliance with: - ISO 13485 - Quality Management System requirements - FDA 21 CFR Part 820 - Quality System Regulation (USA) - Canada Medical Devices Regulations (SOR/98-282) - Brazil RDC 16/2013 - Good Manufacturing Practices - Australia Therapeutic Goods Regulations - Japan MHLW Ministerial Ordinance 169

Benefits of MDSAP participation:
- Single audit replaces multiple country inspections
- Cost and time savings for manufacturers
- Standardized approach to quality management
- Enhanced global market access
- Reduced regulatory burden
- Recognized proof of GMP compliance

MDSAP Auditing Organizations:
Only accredited Auditing Organizations (AOs) can conduct MDSAP audits. These organizations are accredited by members of the International Accreditation Forum (IAF) and authorized by participating regulatory authorities.

MDSAP vs traditional audits:
Without MDSAP, manufacturers must undergo separate inspections by each country's regulatory authority. MDSAP consolidates these into one comprehensive audit, significantly reducing compliance costs and administrative burden.

Participation status: While MDSAP participation is voluntary for most countries, Brazil (ANVISA) requires MDSAP certification for Class III and Class IV medical devices.