02
2021
September
Highlights
PAHSCO awarded the first DNV Asia issued EU CE MDR certificate
DNV Norway headquarters recently issued CE MDR certificate to Pacific Hospital Supply Co., Ltd., which made PAHSCO the first medical device manufacturer to obtain the DNV EU CE MDR certificate, and also the second in the worldwide.
The EU Medical Device Directive has been officially upgraded from the current MDD to the new Medical Device Law MDR, proclaiming that the EU has set more stringent management standards for medical devices. In order to convert to MDR, medical device manufacturers must strengthen clinical evaluation, quality management systems, post-marketing supervision and post-marketing clinical tracking, etc., to ensure the transparency of product information and improve the traceability of supervision.
The DNV representative Manager Zheng-Xiong Lin issued the certificate to PAHSCO. Mr. Lin said, "This MDR certificate not only achieves an important milestone for the loyal partners of DNV and PAHSCO, but also demonstrates a key indicator that PAHSCO, as the leader of Taiwan medical device industry, is moving towards MDR and gaining a foothold in the international market.“
Photo: PAHSCO Chairperson An-Ting Chung (left) and DNV Manager Zheng-Xiong Lin (right)
The EU Medical Device Directive has been officially upgraded from the current MDD to the new Medical Device Law MDR, proclaiming that the EU has set more stringent management standards for medical devices. In order to convert to MDR, medical device manufacturers must strengthen clinical evaluation, quality management systems, post-marketing supervision and post-marketing clinical tracking, etc., to ensure the transparency of product information and improve the traceability of supervision.
The DNV representative Manager Zheng-Xiong Lin issued the certificate to PAHSCO. Mr. Lin said, "This MDR certificate not only achieves an important milestone for the loyal partners of DNV and PAHSCO, but also demonstrates a key indicator that PAHSCO, as the leader of Taiwan medical device industry, is moving towards MDR and gaining a foothold in the international market.“
Photo: PAHSCO Chairperson An-Ting Chung (left) and DNV Manager Zheng-Xiong Lin (right)