2026 Commences with a Look Back, a Look Forward and New Legislation and Guidance

By Evangeline Loh

The past three months have been filled with regulatory developments. As shared in our review of the last quarter of 2025, reviews of the 2025 year and announced priorities for 2026 continue.

2025 annual reports

The U.S. Food and Drug Administration (FDA), true to form, released the 2025 CDRH Annual Report as well as the 2025 International Harmonization Annual Assessment Report in late January. In 2025, the FDA authorized 3,238 510(k)s, 27 De Novo reclassification requests, 41 PMAs (plus 2,210 PMA supplements), including 1,300 AI-enabled devices. The level of vigilance and PMS reports remains constant.  The International Harmonization Annual Report highlighted the FDA’s leadership within the International Medical Device Regulators Forum (IMDRF), as well as its upcoming role as chair of the Medical Device Single Audit Program (MDSAP). Regulatory Authority Council (RAC) for 2026–2027 term. In this capacity, the FDA intends to expand MDSAP participation in Asia. In 2025, the U.S. FDA issued 54 warning letters. 

The annual address by the Medical Device Authority (MDA) in Malaysia provided both a synopsis of 2025, as well as expectations for 2026. Last year, 2025 heralded regulatory reliance programs from the China NMPA, Singapore HSA, and Thai FDA. The MDA also shared a proposed ASEAN framework for a single submission accepted by four countries: Malaysia, Singapore, Thailand and Indonesia. 

2026 looking forward

In addition to the MDA’s 2026 vision, the U.S. FDA shared priorities for guidance documents for 2026, the Brazil regulator, ANVISA, published their priorities for the 2026-2027 year, the European Commission had its consultation for a new proposal to simplify rules for medical devices and IVDs (2025/0404), and 

the Australian Therapeutic Goods Administration (TGA) posted 2026-2027 priority focus areas. 

The UK MHRA opened a consultation on a proposal for indefinite recognition of medical devices compliant with the EU legislation. Likely a welcome initiative because 90% of devices on the GB market possess CE marking. ANVISA attended the ABIOMED meeting at the end of February and further shared objectives for 2026, including an assessment explaining why manufacturers weren’t capitalizing on regulatory reliance initiatives such as AREEs (IN 290/2024) to the levels expected by ANVISA.

The regulator in Singapore, HSA, hosted the 29th IMDRF conference in mid-March. The first two days of the joint industry workshop featured the IMDRF Playbook for Medical Device Regulatory Reliance.  

Legislative updates

In Mexico, a Decree (January 15) modified the General Health Law. Article 376 was amended to expand the renewal validity period of medical device registrations to 10 years. On February 2, the U.S. FDA Quality Management System (QMS) became the QMS Regulation (QMSR), and 21 CFR 820 incorporated by reference ISO 13485:2016. Related to QMS, the GMP legislation was revised in China Announcement No. 107 of 2025, to become effective this November. Brazil released legislation related to UDI, Normative Instruction 426/2026 for the deadlines and requirements related to use of the ANVISA UDI database, SIUD.

The European Commission announced two proposed Delegated Acts to expand the list of well-established technologies (WET) devices in Article 52(4)(b) and Article 61(6)(b) of the MDR.

Guidance updates

Many guidance documents were updated, a few of note. 

The FDA updated the General Wellness Guidance and Clinical Decision Support (CDS) Guidance, while withdrawing the SaMD Clinical Evaluation Guidance. The revised General Wellness guidance now more clearly distinguishes among three categories: products not considered medical devices, products that qualify as general wellness under enforcement discretion, and products that are medical devices and therefore regulated. Similarly, the CDS guidance was clarified to describe non-device CDS and CDS that meet the definition of a medical device. The TGA revised guidance on 𝐫𝐞𝐜𝐚𝐥𝐥𝐬, 𝐩𝐫𝐨𝐝𝐮𝐜𝐭 𝐚𝐥𝐞𝐫𝐭𝐬, 𝐚𝐧𝐝 𝐩𝐫𝐨𝐝𝐮𝐜𝐭 𝐜𝐨𝐫𝐫𝐞𝐜𝐭𝐢𝐨𝐧𝐬 (𝐏𝐑𝐀𝐂) as well as new FAQs and guidance. 

And in the category of not completely guidance …

The FDA also released the updated Compliance Program Manual (CP 7382.850) to accompany the QMSR. The FDA emphasized its risk-based inspection strategy and the importance of risk management documentation. Interested in some insight into differences that exist in regulatory strategy between the US FDA and other regulatory regimes, our featured regulatory insight discusses this: biocompatibility, reprocessing and cybersecurity.

EUDAMED, PARD, and Swissdamed improved, and a new version of the European Manufacturer Incident Report (MIR), released as Version 7.3.1 (SP-11010).

Concluding remarks

The first quarter of 2026 was replete with regulatory developments. 

Our regulatory intelligence teams continue to monitor regulatory developments to assess the impact of regulatory changes on a manufacturer’s global regulatory strategy. We remain optimistic about the new initiatives related to regulatory reliance: we’re anticipating guidance in Japan on Cabinet Order No. 362 of 2025, which becomes effective May 1.