🌍 ISO 13485:2016 Global Standard for Medical Devices - EU, FDA, MDSAP
ISO 13485:2016 outlines the requirements for a quality management system (QMS) where organizations must demonstrate their ability to provide medical devices and related services that consistently meet applicable regulatory and customer expectations. It applies to all stages of the product lifecycle, including design, development, production, storage, distribution, installation, and servicing.
- EU Compliance: Manufacturers intending to market medical devices in the European Union Countries must comply with the The EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The implementation of a Quality Management System (QMS) in accordance with ISO 13485:2016, along with adherence to the requirements set out in EU MDR 2017/745 (MDR) or EU IVDR 2017/746 (IVDR), enables medical device manufacturers to demonstrate regulatory compliance, ensure product safety and performance, and maintain consistent effectiveness throughout the device lifecycle. This is essential for CE marking and regulatory approval.
- Scope of Application: The standard applies based on the type of organization, its activities, and the nature of the medical device.
🇺🇸 FDA QSR Transition to QMSR - Alignment with ISO 13485
In a major regulatory shift, the U.S. FDA has finalized a rule to replace the existing Quality System Regulation (QSR) under 21 CFR Part 820 with the Quality Management System Regulation (QMSR), which incorporates ISO 13485:2016 by reference.
- Effective Date: The new QMSR will take effect on February 2, 2026, with a transition period for manufacturers to align their systems.
- Key Changes:
- Harmonization with international standards
- Simplified regulatory language
- Enhanced global consistency in device quality systems
- Impact: This change streamlines compliance for manufacturers operating in multiple jurisdictions and supports global market access.
🇨🇦 Canada - MDSAP Certification Requirement
Canada mandates participation in the Medical Device Single Audit Program (MDSAP) for manufacturers seeking market access.
- Certification: ISO 13485:2016 certification must be obtained through the Canadian Medical Devices Conformity Assessment System (CMDCAS), now integrated into MDSAP.
- Requirement: Certification is mandatory before marketing medical devices in Canada.
🌐 MDSAP - Participating Countries and Core Requirements
The Medical Device Single Audit Program (MDSAP) allows a single regulatory audit to satisfy the requirements of multiple jurisdictions. It is based on ISO 13485:2016 and includes additional country-specific criteria.
Participating Countries:
| Country | Regulatory Authority |
|---|---|
| United States | FDA |
| Canada | Health Canada |
| Brazil | ANVISA |
| Japan | PMDA and MHLW |
| Australia | TGA |
Key Requirements:
- Compliance with ISO 13485:2016
- Country-specific regulatory requirements (e.g., FDA’s QMSR, ANVISA’s RDC, Japan’s Ordinance No. 169)
- Risk management and post-market surveillance
- Documented procedures and traceability
🛠 Sterling Medical Registration - Your Partner in Compliance
Sterling Medical Registration, led by Daniela Levy, Advocate, specializes in implementing quality management systems for medical device companies. With deep expertise in regulatory affairs and global standards, Sterling ensures your organization is audit-ready and compliant across all target markets.