Pure Global Editorial Team

Mexico has published the COFEPRIS Medical Device Registration Guidance 2026, providing the first comprehensive instructions for preparing registration dossiers under the Equivalence Agreements and Abbreviated Regulatory Pathway. The guidance clarifies expectations for administrative, quality, technical, clinical, and post-market surveillance documentation, with a strong emphasis on document consistency, manufacturing traceability, Spanish-language compliance, and risk-based evidence.

MDA's MeDC@St 2.0+ Automated Re-Registration Route allows eligible medical device registration holders to renew registrations through an automated process. Applications must be submitted within one year before expiry, as expired registrations require a new registration under the Medical Device Act 2012 (Act 737).

Malaysia's MDA and China's NMPA have launched Pilot Phase 2 of the Malaysia-China Joint Evaluation Pilot Programme, open from 1 July to 30 September 2026. The programme enables simultaneous evaluation of eligible medical devices under the GHWP CERP framework to reduce duplicative review and support faster access to both markets.

The Philippine Department of Health has extended the suspension of higher medical device registration fees for another 120 working days from 2 June 2026, keeping CMDR applications under the current lower government fee schedule while Administrative Order No. 2024-0016 remains suspended.

Starting 1 July 2026, Australia's TGA has updated fees and annual charges for medical devices and IVDs, including ARTG application assessments, audit fees, annual charges, and Annual Charge Exemption deadlines. Manufacturers and Australian Sponsors should review portfolio status and payment timelines to avoid unnecessary costs or ARTG disruption.

The European Commission has published Implementing Decision (EU) 2026/1231, updating the list of harmonized standards across several medical device areas. Manufacturers should review technical documentation, declarations, test documentation, and internal standards registers against the revised list.

MDCG 2021-5 Rev.1 clarifies the transition from EC REP to EU REP after EN ISO 15223-1:2021/A1:2025. Manufacturers may use EC REP, EU REP, or both symbols during a 60-month transition ending on 17 June 2031, provided Authorized Representative information remains clear and intelligible.

Malaysia's Medical Device Authority (MDA) and Japan's Ministry of Health, Labour and Welfare (MHLW) have signed a Memorandum of Cooperation (MoC) in Tokyo, marking a significant step toward regulatory alignment and closer collaboration between the two countries. The agreement lays the groundwork for more efficient medical device registration, enhanced information sharing, and improved post-market surveillance frameworks. Manufacturers operating in both markets could benefit from greater regulatory predictability and streamlined market access as the partnership develops.

The U.S. FDA human factors guidance 2026 update revises requirements for human factors information in medical device marketing submissions, including 510(k), De Novo, and PMA pathways. It introduces new risk-based Human Factors Submission Categories 1–3, expands examples for modified devices, and clarifies expectations for usability validation. Sponsors must assess use-related risks, device complexity, and interface changes when determining submission requirements to ensure compliance with FDA usability engineering expectations.

The Swissmedic swissdamed fees 2026 update introduces mandatory medical device registration in Switzerland from 1 July 2026 under MedDO and IvDO. Devices must be registered in swissdamed and will be subject to annual fees based on UDI-DI counts, with a CHF 200 base fee and CHF 20 per additional device, capped at CHF 10,000 per manufacturer. The regulation aligns Swiss medical device registration with lifecycle-based compliance and introduces a transition period until 31 December 2026.

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Mexico has published NOM-137-SSA1-2025, a major overhaul of its medical device labeling standard that introduces stricter traceability requirements, expanded use of international symbols, and stronger sterility labeling expectations. Foreign manufacturers and importers will feel the greatest impact, with likely updates needed across labels, IFUs, and contra-labeling processes. With mandatory compliance kicking in on May 14, 2027, the roughly 360-day transition window makes now the right time to start your gap assessment.

The European Commission has published Regulation (EU) 2026/977, introducing standardized requirements for Notified Bodies that promise to bring much-needed consistency to EU MDR and IVDR conformity assessments. Manufacturers can expect clearer timelines, including a maximum of 90 days for technical documentation assessment and greater cost transparency in NB quotations. With the regulation applying from February 2027, now is the time to start preparing.

The European Commission has released the third 2026 update to the Manufacturer Incident Report (MIR) form version 7.3.1 (SB-11154), addressing technical bugs and compatibility issues affecting electronic vigilance submissions to EU and non-EU regulatory databases. While the changes may seem minor, manufacturers who don't update their workflows risk XML upload failures, rejected submissions, and potential audit nonconformities. Read on to learn what's changed and the concrete steps your regulatory team should take now to stay compliant.

Malaysia’s Medical Device Authority (MDA) has published the first edition of MDA/GD/0072 Change Management for Registered Medical Devices, which will replace MDA/GD/0020 following the official launch of MedCAST 3.0. Until implementation takes effect, the current change notification guidance remains applicable. Companies should review the new guidance and prepare for upcoming regulatory process changes.

Malaysia’s MDA updated the Requirements for Labelling of Medical Devices in 2026 by revising Clause 4.8(e) for foreign manufacturers. Under the new requirement, manufacturer name and address remain mandatory, while contact details such as email, phone number, or website address for technical assistance are now optional. The update provides greater flexibility for medical device labelling compliance in Malaysia.

Singapore and China have renewed their health products regulatory partnership, expanding collaboration into cutting-edge therapies including cell, tissue, and gene therapy products. The updated MOU between Singapore's HSA and China's NMPA aims to streamline regulatory pathways and accelerate patient access to innovative treatments across both countries. For healthcare companies and researchers, the strengthened agreement could unlock new cross-border opportunities in one of the world's fastest-growing life sciences markets.

The CMS and FDA RAPID Coverage Pathway 2026 accelerates Medicare access to breakthrough medical devices by aligning regulatory approval and coverage decisions. It enables early CMS–FDA collaboration, shared clinical evidence, and same-day proposed coverage decisions upon FDA authorization. Eligible devices include certain Class II and Class III breakthrough devices studied in Medicare populations, reducing coverage timelines from over a year to approximately two months.