July 5, 2024
As we move into the latter half of 2024, and as we shared earlier this year, global regulatory harmonization persists.
In this update, we take a whirlwind tour of countries exemplifying regulatory reliance, IVD updates and globalization modeling.
Leveraging regulatory authorizations or more examples of reliance
The Hong Kong MDCAS made effective (April 2) its acceptance of authorizations from the Singapore Health Sciences Authority (HSA). This adds to the countries that could be used to demonstrate compliance with the Essential Principles of Safety and Performance: Global Harmonization Task Force (GHTF) founding members (U.S., EU, Canada, Australia, Japan), China and South Korea.
The Brazil regulator, ANVISA, posted Normative Instruction IN 290/2024 (April 8) which went into effect (June 3). This legislation establishes the Equivalent Foreign Regulatory Authority (AREE) and permits manufacturers (or Brazil Registration Holders) to use authorizations from four of the former GHTF founding members. While this does not reduce the compliance or compilation requirements, it is estimated to decrease ANVISA review time by 30%.
The Medicines and Healthcare products Regulatory Agency (MHRA), the UK regulator, posted a draft policy (May 21) to leverage authorizations from Comparable Regulator Countries (CRCs) comprised of four former GHTF founding members. Depending on the available access route, this would reduce the number of regulatory documents that must be submitted to the MHRA and shorten the review time
Legislative updates, IVDs
IVD legislative updates continue. After many years (decades), the U.S. Food and Drug Administration (FDA) officially published the Final Rule (May 6) on laboratory-developed tests (LDTs). The requirements are phased in and discussed in our update, though the first deadline (Stage 1) will be May 6, 2025. It will impose complaint management and vigilance reporting requirements on LDT manufacturers.
At the same time as the MHRA released draft information about CRCs, there were consultation questions about high-risk IVDs (consultation closed June 14).
Lastly, RDC 830/2023 on IVDs in Brazil became effective June 1. While we still eagerly anticipate publication by the EU of the amending regulation in the EU which updates the In Vitro Diagnostic Devices (IVDR, 2017/746) in the Official Journal of the European Union, there have been tremendous IVD updates.
Global regulatory initiatives
Two developments in Mexico further align medical device requirements globally. The medical device regulator in Mexico, COFEPRIS, released a new draft project (March 12) to revise medical device labeling with ISO 15223, NOM-137-SSA1-2024. We reported on the draft NOM in a four-part series. COFEPRIS also posted two press releases about the authorization of software as a medical device (SaMD) in May, demonstrating that SaMDs must now be authorized as medical devices.
To close out the quarter, the International Medical Device Regulators Forum (IMDRF) released revised (June 25) guidance on the regulatory submissions (Edition 4 of nIVD MA ToC and IVD MA ToC). The guidance represents a significant regulatory update.
Concluding remarks
The first half of the year concludes with regulatory updates that focus on global regulatory harmonization. The IMDRF continues to advance its initiatives. The developments in Brazil and the UK demonstrate that regulators are advancing regulatory reliance. The founding GHTF members still retain a significant impact on global regulatory harmonization.
We at Emergo by UL continue to monitor regulatory developments and celebrate successes in global harmonization.
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