Q4 2025 Continues with Commitments to Market Data Transparency, Regulatory Reliance and Visions for 2026

By Evangeline Loh

It was clear that 2025 was influenced by the IMDRF and MDSAP, and a theme was regulatory reliance : first quarter, second quarter, and third quarter.

Examples of regulatory reliance continue, as well as data transparency initiatives and visions for the upcoming year. 

Regulatory reliance programs continue

The regulator in Malaysia, MDA, continues to advance global harmonization.  Circular Letter Number 2 Year 2025, announced the addition of the Singapore HSA and Thailand FDA to its list of recognized regulatory authorities, adding to European (EU) Notified Bodies, Japan Ministry of Health, Labour and Welfare (MHLW), Australia TGA, Health Canada (HC), US FDA, and UK MHRA. Guidance Document MDA/GD/0068 has also been revised. This expansion reinforces MDA’s commitment to global regulatory reliance with use of the Verification Assessment (for eligible devices from recognized regulatory authorities), a more succinct and efficient review alternative to full conformity assessment.

The MHLW in Japan also published Cabinet Order No. 362 of 2025, marking a major milestone in Japan’s regulatory framework as it established priority review for devices authorized by the US FDA (considered an equivalent regulator). There are conditions, of course (predicate registered in Japan, same device class and JMDN Code, no differences in key properties), though this marks the first example of regulatory reliance in Japan. 

Regulatory databases and market data transparency

As expected, progress was made with the EU database EUDAMED. The European Commission (EC) provided a two-day training on the EUDAMED UDI/Device module in advance of the release of legislation for compulsory use. Finally, the EC published legislation for compulsory use of four modules of EUDAMED (Commission Decision 2025/2371). Starting May 28, 2026, any MDR/IVDR-compliant devices placed on the EU market for the first time must be registered in EUDAMED: Actor Registration, UDI/Device Registration, and Notified Bodies and Certificates, if relevant. Devices already on the market before that date have until November 27, 2026.

We reported on the Health Canada database and the availability of clinical data for Class III and Class IV Medical Device Licenses (MDL) because of the Public Release of Clinical Information (PRCI) initiative. There is an opportunity to meet with HC to redact sensitive information. And, while there is currently no information about unsuccessful MDL applications, the clinical information may still be published. 

Last, while formal legislation about the UDI database in Brazil, SIUD, was expected, one of the priorities identified by the regulator, ANVISA, for 2026-2027 year was this. 

2025 in review and priorities for 2026

The U.S. FDA Center for Devices and Radiological Health  (CDRH) published its priorities for guidance documents for 2026 aligned with the start of the 2026 fiscal year.  The plan is organized into A-List, B-List, and Under Construction. As part of our article, Emergo experts have performed a regulatory assessment of the 2026 plan compared to the 2025 plan.  As the calendar year has concluded, we have completed an analysis of the 54 warning letters issued to medical device manufacturers from 2025. Our regulatory insight included multiple tables documenting the identified deficiencies. 

In Brazil, ANVISA published their priorities for the 2026-2027 year (December 16), effective January 1. On the priority list are 14 topics for medical devices. Emergo experts discussed the 14 topics as well as a few relevant general topics in our update. We are interested in all regulatory developments, though are particularly tuned into a discussion about requiring MDSAP certificates for non-Brazil-based manufacturers. 

Developments in the EU in December have been tremendous. Many guidance documents were posted or updated, including a new MDCG 2025-10 on PMS. Release of the long-awaited Manufacturer Incident Report (MIR) MIR version 7.3.1 form (SB-10781) (December 22), which becomes mandatory May 1. The EC has an open feedback period on Proposed Commission Implementing Regulation introducing uniform quality management and procedural requirements for conformity assessment activities by notified bodies under Regulations (EU) 2017/745 and 2017/746 (closes January 23) and a new proposal to simplify rules for medical devices and IVDs (2025/0404, December 16). 

Concluding remarks

Regulatory reliance and the concept of leveraging other regulators’ authorizations was in full development in 2025, most notably in the second half of 2025. The Mexican regulator, COFEPRIS, expanded the countries considered equivalent (RRA), UK MHRA moved more formally to CRCs, and the MDA has pilot programs with the China NMPA and Singapore HSA, as well as recognizing the HSA and Thailand FDA for abbreviated review. In a new decision, the Japan MHLW identified the U.S. FDA as an equivalent regulator. Regulators continue to demonstrate their confidence in MDSAP. The U.S. FDA QMSR will soon take effect and incorporate by reference ISO 13485 (February 2). MDSAP launched their official website, the EC expressed interest, and affiliate member memberships increased. And, ANVISA proposes to discuss requiring MDSAP certificates for non-Brazil-based manufacturers in 2026-2027. 

On behalf of Emergo (our global consulting experts and amazing colleagues), we remain exuberant for the 2026 year and look forward to sharing the regulatory developments!