Global Medical Device Registration: Regulatory Expectations Across Key Markets

Global Medical Device Registration: Regulatory Expectations Across Key Markets

Bringing a single medical device to various international markets is rarely a “copy and paste” exercise. While the core science remains consistent, the specific regulatory expectations governing classification, evidence, and post-market oversight differ significantly across jurisdictions.

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Snapshot of Key Regulatory Frameworks

EU MDR (European Union)

• Focus: Detailed and often stricter device classification rules.
• Emphasis: Strong focus on clinical evidence, Post-Market Surveillance (PMS), and Post-Market Clinical Follow-up (PMCF).
• Process: Requires Notified Body involvement for most devices and subjects legacy products to close scrutiny.

FDA 510(k) / De Novo (USA)

• Focus: The 510(k) pathway relies on demonstrating substantial equivalence to an already legally marketed predicate device.
• Emphasis: Clear focus on benefit-to-risk ratio and increasing use of real-world evidence.
• Process: The De Novo pathway is available for novel, lower-risk devices without a suitable predicate.

UKCA (Great Britain)

• Focus: Currently broadly aligned with the old EU MDD.
• Process: Uses its own pathway and timing. Notified Bodies are now referred to as Approved Bodies.
• Future Note: Future divergence from EU requirements is expected, making strategic planning essential.

TGA (Australia)

• Focus: Leans heavily on conformity assessment.
• Emphasis: Options exist to leverage evidence and approvals from other major regulators. Growing attention is placed on software, cybersecurity, and post-market monitoring.

Health Canada (Canada)

• Focus: Risk-based classification with a strong expectation for a robust quality management system.
• Process: Certain higher-risk classes require detailed licensing and clinical data. There is a clear and active focus on safety signal detection and recalls.

PMDA and MHLW (Japan)

• Focus: Classification structure is similar to other markets, but the review process is highly process-driven.
• Emphasis: Close oversight of clinical evidence, quality systems, and risk management. Many devices require third-party certification, and higher risk devices undergo direct PMDA review. Local clinical data may be required depending on the device type and intended use.

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Streamlining Global QMS Oversight: MDSAP

The Medical Device Single Audit Program (MDSAP) allows a single quality management system (QMS) audit to be recognized by multiple authorities, including the FDA, TGA, and Health Canada.

• Role: While MDSAP does not replace local regulatory submissions, it significantly streamlines the QMS oversight and auditing process across participating markets, improving efficiency for manufacturers with global footprints.