Kitazato (368A) · RiskFirst stated

Risks from Changes in, and Delays in Responding to, Medical Device Regulations and Certification Requirements in Different Countries

First written in FY2026. . Latest entry: FY2026.

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How it moved

Same theme, other companies

Uncertainty in Obtaining Certifications and Approvals for Medical Devices and Responding to Healthcare SystemsA theme 11 companies write about · 13 as a headwind · 0 as a tailwind

The whole theme swung hardest in 2026: 3 of 7 companies on the "Worse" side.

0 other companies' latest entry also says "First stated".

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Full recordFilings, disclosures and news, newest first

FY2026First statedAnnual report
「Overseas, the tightening of medical device regulations in individual countries and regions is increasing the need to register medical device products in accordance with local requirements. Specifically, exports to Europe require compliance with the MDR (European Medical Device Regulation), while exports to the United States require registration with the FDA (U.S. Food and Drug Administration).」
The Company identifies the need to comply with regulations in each country, including the MDR and FDA requirements, and the possibility that responding to regulatory changes and tightening may take time as a risk.

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Kitazato's next results are scheduled for 2026-10-28. Read the earnings preview

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