TÜV SÜD Japan's Yonezawa Testing Centre Accredited Under FDA ASCA for EMC Testing

TÜV SÜD Japan Ltd. has announced that its Yonezawa Testing Centre has received accreditation under the FDA's ASCA (Accreditation Scheme for Conformity Assessment) programme for EMC standards. The accreditation allows TÜV SÜD Japan, a subsidiary of TÜV SÜD, to issue FDA ASCA Summary Test Reports for EMC testing, adding to its existing electrical safety testing services.

The accreditation scope covers EMC standards for medical devices, including IEC 61326-2-6:2025, an EMC standard specific to in vitro diagnostic devices (IVDs). TÜV SÜD Japan is the first FDA ASCA-accredited laboratory in Japan to include this particular standard within its accreditation scope.

FDA ASCA is an FDA-run accreditation programme intended to streamline premarket review for medical devices and IVDs. Manufacturers seeking FDA market authorization can use ASCA-accredited labs to generate an ASCA Summary Test Report, which is submitted alongside the standard test report as part of their regulatory filing — offering a standardized path to demonstrating conformity with recognized standards and potentially speeding up the review process.

The Yonezawa Testing Centre's new EMC accreditation (ASCA ID: TL-171) confirms compliance with both ISO/IEC 17025 requirements and FDA ASCA programme requirements. It builds on TÜV SÜD Japan's earlier ASCA accreditation for electrical safety testing at its Tokyo Testing Centre, obtained in 2023 (ASCA ID: TL-116). With this addition, the company now offers FDA ASCA-recognized testing across both electrical safety and EMC requirements for medical devices and IVDs.

TÜV SÜD Japan operates as a Notified Body under the EU's MDR and IVDR regulations, and was the first certification body registered under Japan's Pharmaceuticals and Medical Devices Act by the Ministry of Health, Labour and Welfare. The Yonezawa Testing Centre itself is an ISO/IEC 17025-accredited laboratory located in Yamagata, Japan.