2025 Q3: Commitments to Market Data Transparency and Regulatory Reliance

Evangeline Loh

Three-fourths into 2025 (the first and second quarters are now behind us), quarter three continues to be influenced by the International Medical Device Regulators Forum (IMDRF), the Medical Device Single Audit Program (MDSAP), and ongoing efforts in regulatory reliance.

Many developments this quarter are examples of regulatory reliance. Initiatives to promote data transparency continue, and our last topic notes noteworthy developments in the U.S., EU and Canada.

Many examples of regulatory reliance

It may have only been three months, though it was replete with examples of the IMDRF regulatory reliance. In Mexico, a new Equivalence Agreement was released (July 18), expanding the countries suitable for equivalence. Authorizations from Reference Regulatory Authorities (RRA), the Management Committee of the IMDRF, and full members MDSAP: Australia, Brazil, Canada, China, European Union, Japan, Russia, Singapore, South Korea, Switzerland, the United Kingdom and the U.S. can be leveraged. This became effective Sept. 1. Shortly thereafter, another legislation (Aug. 22) was released, simplifying and consolidating medical device legislation and homoclaves. The Equivalence Agreements from 2010 (U.S. Food and Drug Administration (FDA) and Health Canada) and 2012 (Japan Ministry of Health, Labour and Welfare (MHLW) were eliminated effective Oct. 6. Emergo by UL will report on experience with the Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS) and RRA.

The regulator in Malaysia, the Medical Device Authority (MDA), announced (July 16, July 22) a pilot for in vitro diagnostics (IVDs) between the MDA and China’s National Medical Products Administration (NMPA) to reduce review times. IVDs manufactured in Malaysia in a manufacturing facility owned by the manufacturer and registered with MDA can use the NMPA Green Channel program. IVDs manufactured in China in a manufacturing facility owned by the manufacturer and registered with NMPA can use the Verification pathway with the MDA. This is estimated to reduce the NMPA review time from two years to 60 working days and MDA + Conformity Assessment Body from 90 days to 30 days. The MDA and Singapore’s Health Sciences Authority (HSA) shared details of a pilot between the two regulators at the Association of Southeast Asian Nations (ASEAN) meeting (Aug. 22, MDARIS#376| (17) MDA.6-2/1/4 JILID 5). The pilot commenced on Sept. 1 and ends on Feb. 28, 2026, expediting review for Class B, C and D devices.

During this time, the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) shared the outcome of the public consultation (July 22) on the future legislation. It is clear that routes in comparable regulator countries (CRCs) will be implemented to permit international reliance. Interested in Emergo by UL’s assessment of the reliance legislation in Brazil? This Regulatory Insight discusses our experience with Normative Instruction 290/2024.

Regulatory databases and market data transparency

Data and database development continue. The Unique Device Identification (UDI) Devices Module, which provides more functionality in the Swiss medical device database, swissdamed, is available. Device registration becomes mandatory on Jan. 1, 2027. If a vigilance or post-market surveillance (PMS) occurs after July 1, 2026, the devices will need to be registered.

The regulator in Brazil, Agência Nacional de Vigilância Sanitária (ANVISA), has hosted a public event on the UDI System (June 30) and released an Official Notice on July 10. The Official Notice summarizes the state of UDI in Brazil, references legislation and guidance, provides examples of UDI on labeling, and shares the website for reference materials for the UDI database, Sistema de Identificação Única de Dispositivos Médicos (SIUD). We are still monitoring for the release of Normative Instruction on SIUD.

Brazil also released the Single Import Declaration (DUIMP) petitions using the Single Foreign Trade Portal. This permits real time access by both ANVISA and the Federal Revenue Service of documents for swifter importation clearance. The corresponding released ANVISA manual affirms the continuance of the Declaration of Registration (DDR) Holder model.

We expect updates on the European Database on Medical Devices (EUDAMED) in Q4 of this year.

Noteworthy developments in the U.S., EU and Canada

The U.S. FDA revised the definition of IVD products, 21 CFR §809.3(a), to the pre-2024 definition, to acknowledge the revocation of the Final Rule on Laboratory Developed Tests (LDTs). Revocation of the Final Rule on LDTs generally re-aligns the regulatory requirements for these types of IVDs in the U.S. with the EU (Article 5(5)). From the writing of this Insight, the U.S. FDA Quality Management System Regulation (QMSR) will take effect on Feb. 2, 2026.

The European Commission (EC) has a month-long consultation (September 8-October 6) to collect feedback on how to simplify the MDR and IVDR, with a draft document by the end of the year.

Health Canada announced the second pilot (August 2025, submit MDL in 2025) on the electronic Submission Template Resource (eSTAR). The eSTAR pilot would be for Class III and Class IV Medical Device Licenses (MDLs), prioritizing IVDs.  

Concluding remarks

The year is not over, and regulators continue to advance the activities of the IMDRF and MDSAP.

Regulatory reliance and the concept of leveraging other regulators’ authorizations continue. COFEPRIS expands the countries considered equivalent (RRA), MHRA moves more formally to CRCs, and the MDA has pilot programs with the NMPA and HSA.

Regulators demonstrate confidence in the MDSAP Quality Management System (QMS). The U.S. FDA Quality System Regulation (QSR) will soon take effect and incorporate ISO 13485 by reference. MDSAP launches its official website, the EC expresses interest, and affiliate memberships increase.