Regulatory newsfeed
Curated developments across the seven frameworks GORA AI covers — so your launch strategy never runs on stale guidance.
With staggered transition provisions for legacy devices, manufacturers of Class III and implantable devices should re-confirm Notified Body capacity and conformity-assessment scheduling well ahead of certificate expiry.
Read summary →Updated guidance emphasises clearer predicate rationale and performance testing for PTCA and peripheral angioplasty catheters. Teams should align bench, animal, and clinical evidence to the stated product code early.
Read summary →As Switzerland's device database expands, economic operators are reminded to verify CH-REP appointments, CHRN registration, and importer linking to keep market access uninterrupted.
Read summary →As additional EUDAMED modules move toward mandatory status, manufacturers should prepare actor, UDI, and device registration data now to avoid bottlenecks at go-live.
Read summary →Refined expectations on clinical-evaluation exemptions and local data requirements affect registration strategy for overseas manufacturers entering the Chinese market.
Read summary →Early consultation continues to shorten review for high-risk implants. Sponsors should scope Shonin requirements and foreign clinical-data acceptability before filing.
Read summary →For drug-coated balloons and drug-eluting stents, regulators continue to stress integrated safety and effectiveness data reflecting the ancillary medicinal action.
Read summary →Teams launching in parallel are building a shared evidence core — clinical evaluation, risk management, biocompatibility — then layering jurisdiction-specific requirements on top.
Read summary →Comparable-overseas-regulator pathways can streamline ARTG inclusion. Confirm conformity-assessment evidence and sponsor responsibilities to use them effectively.
Read summary →These entries are curated, illustrative summaries for orientation only. Always confirm the current text and effective dates with the relevant authority before acting. Inside the workspace, GORA AI links each requirement to its versioned source record.
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