Swissmedic’s 2024 Hospital Inspections Report reveals widespread compliance gaps in Swiss hospitals’ medical device management, from weak quality systems and staff training to cybersecurity risks and inadequate vigilance reporting. Resource constraints, structural inefficiencies, and workforce shortages are cited as root causes. To close these gaps, Swissmedic urges hospitals to strengthen training, infrastructure, cybersecurity, and reporting practices to safeguard patient safety and regulatory compliance.

Mexico’s regulatory authority, COFEPRIS, has issued new measures to simplify medical device registration, including clearer application codes by risk class and reduced approval timelines. These updates aim to streamline market access for both domestic and international manufacturers while maintaining regulatory oversight.

Swissmedic has activated the swissdamed UDI Devices module, marking a significant step toward mandatory medical device registration in Switzerland. While use of the system is currently voluntary, all medical devices, IVDs, and procedure packs must be registered by 1 July 2026.

Malaysia’s MDA and Singapore’s HSA have launched a six-month Regulatory Reliance Pilot to streamline Class B–D medical device approvals. By leveraging each other’s reviews, the initiative cuts duplication, shortens timelines, and accelerates patient access to safe, innovative technologies. If successful, this program could evolve into a long-term ASEAN reliance framework, reshaping regional market entry.

Anatel’s new Resolution 780/2025 reshapes telecom compliance in Brazil. Marketplaces are now jointly liable for irregular sales, refurbished products face stricter requirements, and data centers must undergo conformity assessments. The update expands sanctions and applies the Consumer Protection Code, raising the stakes for manufacturers, importers, and digital platforms.

Swissmedic’s August 2025 update brings Switzerland’s systems and procedure pack (SPP) rules in line with EU MDR/IVDR, tightening requirements for registration, labelling, and vigilance reporting. Assemblers now have just three months to register with Swissmedic, and can expect random inspections to verify compliance.

The EU Notified Bodies Survey 2025 highlights rising MDR and IVDR certification activities but also ongoing challenges with capacity and documentation. Manufacturers should proactively plan their certification strategies to ensure timely compliance and market access across the European Union.

FDA’s 2025 user fee guidance updates small business fee waiver rules, detailing financial hardship criteria and replacing Forms 3602/3602A with Form 3602N. It supports small medical device companies by clarifying eligible documentation, including for entities in tax-exempt jurisdictions, to ease FDA registration costs and encourage market entry.

Mexico’s COFEPRIS has introduced a new Abbreviated Regulatory Pathway, effective September 1, 2025, allowing medical device manufacturers to leverage prior approvals from IMDRF or MDSAP member authorities. This fast-track route reduces documentation requirements and mandates a 30-day decision timeline, aligning Mexico’s regulatory framework more closely with international standards.