Insights
Notes from the regulatory desk.
Practical articles on FDA, EU MDR / IVDR and international registration, written by our team.
FDA's QMSR FAQ: what manufacturers need to know
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.
Read articlePlanning device changes in advance: FDA's 2024 draft guidance on PCCPs
FDA's August 2024 draft guidance extends predetermined change control plans to all device types.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.
Read articleDoes FDA accept clinical trial data from China?
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.
Read articleRegulatory update, November 2026: what changed in October
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.
Read articleRegulatory update, October 2026: what changed in September
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.
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