TAUNS Laboratories (197A) · RiskDetails of IVDR compliance status
Domestic and Overseas Pharmaceutical and Medical Device Regulatory Changes and Approval Responses
First written in FY2024. . Latest entry: FY2026.
2entries
3years
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Medical Device Regulatory and Licensing ComplianceA theme 16 companies write about · 16 as a headwind · 0 as a tailwind
The whole theme swung hardest in 2018: 1 of 7 companies on the "Worse" side.
0 other companies' latest entry also says "Other".
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Showing 14 of the 16 companies compared. The sentences above are computed from all 16.Full recordFilings, disclosures and news, newest first
- FY2026Details of IVDR compliance statusAnnual report
「Of our products, Capilia TB-Neo, a tuberculosis test, has obtained IVDR approval, while the other products are registered under the IVDD.」
While the company disclosed that its tuberculosis testing product had obtained IVDR approval, it also stated that Flu Neo, Adeno Neo and RSV Neo had Confirmation Letters valid through 26 May 2027, sales periods through 31 December 2029 and plans to obtain approval. It also stated that it would for the time being defer obtaining IVDR approval for its other products. - FY2024First statedAnnual report
「If we are unable to submit applications under the IVDR by 2027, we will no longer be able to sell these products in Europe. We are therefore responding sequentially on a product-by-product basis.」
Changes in regulations, including the PMD Act, overseas regulatory requirements, the European IVDR, and the U.S. QMSR, are identified as risks. The company is gathering information and considering responses with the relevant departments.