ISO 13485:2026 Annex A revision introduces AI remote audit rules—critical for medical device manufacturers & suppliers. Act now to ensure compliance, avoid 2027 surveillance disruptions.

RCM certification update for vital sign sensors in Australia: SAA report + EMC raw data (CSV) now mandatory from 22 May 2026—act now to avoid delays.

US-China Joint Statement on Agri-Trade Facilitation and IVD Hardware Test Recognition: Key implications for medical device exporters, regulators & labs—stay ahead of pilot developments.

Fruit Attraction 2026 booth bookings top 90%—Bio-Sample cold chain gear takes center stage. Discover smart storage, blockchain traceability & EU compliance insights.

Lomitech Remote Monitoring drew strong Latin American interest at Hospitalar 2026—key focus on ANVISA/CE compliance, cloud interoperability & AI-driven remote patient monitoring.

EU green packaging rules for IVD hardware take effect Jan 2027—recyclability ≥95%, PFAS ban. Act now to secure supply chain compliance & market access.

ASEAN MDSR Cold Chain Blockchain Mandate takes effect May 2026—mandating ISO/IEC 20008-certified blockchain tracking for temp, humidity & vibration across ASEAN medical device exports. Act now to avoid delays.

FDA mandates API-based batch traceability for centrifuge rotor materials—key for U.S. exporters, alloy suppliers & OEMs. Act now to ensure UDI compliance by Q3 2026.

MFDS now accepts YY/T 0640-2025 biological reports for smart orthotics—cut testing time by 4–6 weeks & costs by 35–45%. Learn how to qualify & export faster to Korea.