https://medreglo.com/en/insights/ Practical notes on FDA, EU MDR / IVDR and international medical device registration. en https://medreglo.com/en/insights/fda-qmsr-faq/ https://medreglo.com/en/insights/fda-qmsr-faq/ Sat, 07 Nov 2026 02:52:28 GMT QMS QMSR has been in effect since 2 February 2026. FDA retired QSIT, introduced a new inspection process, and brought internal audit, supplier audit and management review reports into scope. The 13 FAQs, summarized, with our reading. https://medreglo.com/en/insights/fda-pccp-draft-guidance/ https://medreglo.com/en/insights/fda-pccp-draft-guidance/ Fri, 06 Nov 2026 02:22:21 GMT FDA FDA's August 2024 draft guidance extends predetermined change control plans to all device types. What a PCCP can and cannot cover, and whether one is worth it for a PRP centrifuge. https://medreglo.com/en/insights/fda-china-clinical-data/ https://medreglo.com/en/insights/fda-china-clinical-data/ Thu, 05 Nov 2026 03:04:36 GMT FDA In its regulations, FDA has never refused clinical data from China. What decides acceptance is population representativeness, comparable standard of care and verifiable data, and Bayesian methods offer a quantifiable way to borrow data from outside the US. https://medreglo.com/en/insights/2026-11-regulatory-update/ https://medreglo.com/en/insights/2026-11-regulatory-update/ Tue, 03 Nov 2026 14:28:48 GMT Monthly update China's new device GMP took effect on 1 November; EUDAMED registration for devices already on the EU market closes on 28 November; the US, EU and Australia keep refining their rules for medical device software. https://medreglo.com/en/insights/2026-10-regulatory-update/ https://medreglo.com/en/insights/2026-10-regulatory-update/ Tue, 03 Nov 2026 13:49:38 GMT Monthly update FDA confirms radiology AI software still needs a 510(k); the FY2027 FDA annual registration window opened on 1 October; EUDAMED registration for devices already on the EU market closes on 28 November.