MDSAP certification differs from 13485

The main differences between MDSAP certification and ISO 13485 certification lie in their scope, purpose, applicability, and market access requirements.

Scope and purpose: ISO 13485 is an international standard focused on quality management systems for medical devices, ensuring product quality and safety. MDSAP is a multinational certification program aimed at meeting the market requirements of multiple countries (such as Australia, Brazil, Canada, Japan, and the United States) through a single audit, simplifying and reducing the audit and certification work for enterprises in these markets. ‌

Scope of application: ISO 13485 is mainly applicable to the quality management system of medical device manufacturers, while MDSAP not only applies to manufacturers, but also includes distributors and after-sales service to ensure the compliance of the entire supply chain. ‌

Market access: ISO 13485 certification helps manufacturers meet market access requirements, but does not directly involve recognition in multiple national markets. In contrast, MDSAP can help manufacturers gain recognition and meet market access requirements in multiple countries through a single audit.

Certification bodies and audits: ISO 13485 certification is usually conducted by independent certification bodies, while MDSAP certification is carried out by accredited MDSAP audit bodies, which must be approved by the MDSAP Management Committee and audited in accordance with MDSAP regulations.

In summary, although MDSAP includes the requirements of ISO 13485, it is a more comprehensive multi country certification program designed to meet the market demands of multiple countries through a single audit, while ISO 13485 is an international standard that focuses more on quality management systems.