ISO 13485 and MDSAP medical device quality certifications are two of the most important signals a procurement team or distributor can use to evaluate a manufacturer before signing any agreement. Both confirm that a manufacturer has an independently audited quality management system. Both determine whether a device can legally reach specific markets. And since February 2026, ISO 13485 has become the formal foundation of FDA quality system requirements in the United States as well. For anyone evaluating a video laryngoscope supplier across the U.S., Canada, or the UK, understanding what these certifications mean and what to look for is essential due diligence. This guide explains exactly what ISO 13485 MDSAP medical device quality certification covers and how to verify it before signing any agreement.
What ISO 13485 is and why it matters
ISO 13485:2016 is the international standard for quality management systems in the medical device industry. Published by the International Organization for Standardization, it defines the requirements an organisation must meet to demonstrate its ability to consistently provide medical devices that meet customer and regulatory requirements.
Unlike ISO 9001, which applies across all industries, ISO 13485 is purpose-built for medical devices. It places heavy emphasis on risk management, regulatory compliance, traceability, and process validation. These are the elements that matter when the product you ship is used inside a patient’s airway.
As MedDeviceGuide’s ISO 13485 certification guide explains, ISO 13485 is now the foundation of QMS requirements in the EU through Notified Bodies, the US through the FDA’s QMSR, Canada through MDSAP, Australia, Brazil, and Japan. The era of maintaining separate FDA QSR and ISO 13485 systems is over.
ISO 13485 certification covers the full device lifecycle: design and development, production, installation, servicing, and post-market surveillance. A manufacturer holding a current ISO 13485 certificate has had its quality management system independently audited by a recognised certification body such as BSI, TUV SUD, SGS, Intertek, or Bureau Veritas. The certificate is not self-declared. It is issued following a structured audit process.
What changed with the FDA QMSR in February 2026
The most significant recent development for U.S. buyers is the FDA’s Quality Management System Regulation (QMSR). The QMSR was published in the Federal Register on February 2, 2024 and took effect on February 2, 2026. It amends 21 CFR Part 820 by incorporating ISO 13485:2016 by reference, replacing the standalone Quality System Regulation (QSR) that had been in place since 1996.
As MedStrato’s 2026 tender compliance guide confirms, major U.S. GPOs including Premier, Vizient, HealthTrust, and Intalere began updating their vendor qualification questionnaire templates in Q4 2025. By mid-2026, most Tier 1 GPO formulary applications require QMSR-aligned quality documentation. For Class II and Class III medical devices, ISO 13485 third-party certification from an MDSAP-recognised certification body is now effectively required for Tier 1 GPO formulary access.
This means that for procurement teams evaluating video laryngoscope suppliers for U.S. hospitals, an ISO 13485 certificate is no longer just a nice-to-have signal of quality. It is a practical prerequisite for GPO-contracted purchasing. Suppliers presenting pre-QMSR quality documentation risk failing GPO vendor qualification reviews even if their underlying quality systems are sound.
For context on how GPO vendor qualification works in practice, see our guide on how U.S. GPOs and IDNs shape video laryngoscope procurement decisions.
What MDSAP is and how it differs from ISO 13485
ISO 13485 and MDSAP are related but distinct. ISO 13485 is the standard. MDSAP is an audit program.
The Medical Device Single Audit Program (MDSAP) is an international initiative that allows a single regulatory audit of a medical device manufacturer’s quality management system. MDSAP enables recognised Auditing Organisations to conduct one audit that satisfies the quality system requirements of five regulatory authorities simultaneously: the U.S. FDA, Health Canada, Australia’s TGA, Brazil’s ANVISA, and Japan’s MHLW/PMDA. The UK MHRA participates as an observer.
The practical difference is this: ISO 13485 certification is issued by a certification body and confirms compliance with the international standard. MDSAP certification is issued by a recognised Auditing Organisation and confirms compliance with ISO 13485 plus the country-specific regulatory requirements of all five MDSAP participating jurisdictions. ISO 13485 is the foundation. MDSAP builds the regulatory overlay on top of it.
As Emergo by UL explains, a manufacturer with existing ISO 13485 certification can upgrade their QMS to meet MDSAP requirements by adding the specific procedures and documentation required by each MDSAP participating country. The MDSAP auditing organisation must be recognised by all five participating regulatory authorities. Recognised bodies include BSI, TUV SUD, SGS, UL, and DNV.
Why MDSAP matters specifically for the Canadian market
MDSAP is the single most important quality certification for manufacturers targeting the Canadian market. Since January 2019, Health Canada has required all manufacturers of Class II, III, and IV medical devices to hold MDSAP certification as a prerequisite for obtaining a Medical Device Licence (MDL). An ISO 13485 certificate alone is not sufficient for Canada. The certificate must come from an MDSAP-recognised Auditing Organisation.
Video laryngoscopes are Class II medical devices in Canada. Any manufacturer seeking a Canadian MDL for a video laryngoscope system must hold a valid MDSAP certificate. Distributors evaluating manufacturers for the Canadian market should confirm MDSAP status before any commercial discussion. A manufacturer without MDSAP cannot obtain a Canadian MDL. Without an MDL, the device cannot legally be sold in Canada.
For the full Canadian registration pathway, including MDL and MDEL requirements, see our medical device registration in Canada distributor walkthrough.
How ISO 13485 and MDSAP certification converge in 2026
The ISO 13485 MDSAP medical device quality convergence story is clearly captured in MedDeviceGuide’s analysis: with the FDA’s QMSR formally incorporating ISO 13485 into 21 CFR 820, the U.S. regulatory baseline now structurally mirrors what MDSAP has used for years. MDSAP and QMSR are no longer parallel pathways. They are converging.
For manufacturers selling across the U.S., EU, Canada, Australia, Brazil, and Japan, a single well-implemented ISO 13485-based QMS audited through MDSAP can now satisfy regulatory quality system requirements across all six jurisdictions. This is the closest the medical device industry has come to true global regulatory harmonisation for quality management.
For procurement teams and distributors, this convergence simplifies supplier evaluation. A manufacturer holding a current MDSAP certificate from a recognised auditing organisation meets the quality system requirements for the U.S. (QMSR), Canada (MDSAP mandatory), Australia, Brazil, and Japan simultaneously. That single certificate is the strongest quality signal available in the current regulatory environment.
What procurement teams should verify before buying
ISO 13485 and MDSAP certification claims are verifiable. Procurement teams should verify the following before accepting any quality documentation from a manufacturer:
Confirm the certificate is current. ISO 13485 and MDSAP certificates carry expiry dates. An expired certificate has no regulatory value. Ask for the current certificate with the validity period clearly shown.
Confirm the certification body is recognised. For ISO 13485, the certification body should be accredited under ISO 17021. For MDSAP, the auditing organisation must be officially recognised by the MDSAP participating regulatory authorities. Recognised bodies include BSI, TUV SUD, TUV Rheinland, SGS, Intertek, Bureau Veritas, DNV, and UL.
Confirm the scope covers the device you are buying. ISO 13485 certificates include a defined scope statement covering specific device types or product categories. Confirm the video laryngoscope system you are evaluating falls within the scope of the certificate.
Confirm MDSAP status for Canadian distribution. If you are distributing in Canada, a standalone ISO 13485 certificate does not satisfy Health Canada’s requirements. Confirm the manufacturer holds a specific MDSAP certificate, not just an ISO 13485 certificate.
Check for open non-conformities. Ask the manufacturer to confirm whether any major or minor non-conformities were raised in their most recent audit and what corrective actions were taken. A manufacturer with unresolved major non-conformities carries regulatory risk.
What ISO 13485 and MDSAP certification means for Astra-vue
Astra-vue’s video laryngoscope systems are built on Goldstar Medical’s manufacturing heritage. The quality management system underpinning Astra-vue’s product line is certified to ISO 13485 standards and supports MDSAP compliance requirements for the target markets of the USA, Canada, and UK.
For procurement teams requesting quality documentation as part of a tender or vendor qualification process, or for distributors requiring manufacturer certification documentation before entering a distribution agreement, contact our team directly. Full certification documentation is available on request. To explore the product line, visit our products page.
Frequently asked questions about ISO 13485 and MDSAP for medical device buyers
What is ISO 13485 and why does it matter for medical device procurement?
ISO 13485:2016 is the international standard for quality management systems in the medical device industry. It defines the requirements a manufacturer must meet to demonstrate consistent ability to produce safe and effective medical devices. Holding a current ISO 13485 certificate means a manufacturer’s quality system has been independently audited by a recognised certification body. Since February 2026, ISO 13485 has also become the formal foundation of FDA quality system requirements in the United States through the QMSR.
What is the difference between ISO 13485 and MDSAP?
ISO 13485 is the international quality management standard. MDSAP is an audit program that verifies compliance with ISO 13485 plus the country-specific regulatory requirements of five jurisdictions: the U.S., Canada, Australia, Brazil, and Japan. A manufacturer can hold ISO 13485 certification without MDSAP. However, MDSAP certification is mandatory for the Canadian market and represents the strongest combined quality and regulatory signal across all five jurisdictions.
Is MDSAP mandatory for selling medical devices in Canada?
Yes. Since January 2019, Health Canada requires all manufacturers of Class II, III, and IV medical devices to hold MDSAP certification from a recognised Auditing Organisation as a prerequisite for obtaining a Medical Device Licence. An ISO 13485 certificate alone does not satisfy this requirement. Video laryngoscopes are Class II devices in Canada and therefore require the manufacturer to hold a valid MDSAP certificate.
How do I verify a manufacturer’s ISO 13485 or MDSAP certification?
Ask the manufacturer to provide the current certificate with the validity date and certification body name clearly shown. Confirm the certification body is accredited under ISO 17021 for ISO 13485. For MDSAP, confirm the auditing organisation is officially recognised by the MDSAP participating regulatory authorities. Also confirm the scope of the certificate covers the specific device you are evaluating.
What did the FDA QMSR change for U.S. medical device procurement in 2026?
The FDA QMSR, effective February 2, 2026, amended 21 CFR Part 820 to incorporate ISO 13485:2016 by reference. This formally aligned U.S. quality system requirements with the same international standard used by the EU, Canada, Australia, Brazil, and Japan. Major U.S. GPOs updated their vendor qualification processes following the QMSR’s effective date. ISO 13485 certification from an MDSAP-recognised body is now effectively required for Tier 1 GPO formulary access for Class II and Class III devices.
