Certification

FDA 510(K)

When medical devices are imported into a U.S. market, they must be approved by Food and Drug Administration (FDA) in advance. St.Shine intends to develop the market in U.S. through Optical Connection Inc.. The corporation submitted Section 510(k) premarket notification to FDA on March 21, 2002. After FDA review, the clearance letter was received on May 6, 2002, allowing us to begin ISO 13485 & marketing lenses in United States.

ISO 13485 & CE Marking

obtained the certificate of European Quality System for medical devices and can proudly use CE marking on all products since 1996

GMP

prepared aggressively to meet the medical device regulation for "Good Manufacturing Practice."
On February 10, 1999, the Department of Health in Taiwan mandated that all manufacturers of medical devices must meet GMP regulation. St.Shine was proud to announce that it obtained the GMP Certification that year

ISO 13485 (CMDCAS) & ISO 9001

The quality management system for medical devices imported to Canada is required to conform to the regulatory requirements of CMDCAS by Health Canada. In order to meet the Canadian regulatory requirements to develop the local market, St.Shine has obtained the certificate of ISO 13485: 2003 under CMDCAS according to the plan and also continuously obtained the certificate of ISO 9001:2000 in the meantime.