Products and Services

Certification

ISO 13485 & CE marking

QMS(Taiwan)

MDSAP(USA, Canada, Australia and Japan)

ISO 13485 & CE marking

St.Shine Optical obtained the certificate of European Quality System for medical devices and can proudly use CE marking on all products since 1996, becoming the first contact lens manufacturing company to achieve these certifications in Taiwan and Asia.

QMS(Taiwan)

St.Shine Optical 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, making it the first domestic contact lens manufacturer to achieve such certification. Furthermore, in 2022, St.Shine successfully obtained the Taiwan Ministry of Health and Welfare's Quality Management System (QMS) Manufacturing License Certification for medical devices.

MDSAP(USA, Canada, Australia and Japan)

MDSAP (Medical Device Single Audit Program) is an audit program jointly initiated by members of the International Medical Device Regulators Forum (IMDRF). It serves as a comprehensive audit scheme for quality management systems, addressing the regulatory requirements of health authorities in countries such as the United States, Canada, Australia, Japan, and others. MDSAP is conducted by authorized third-party audit organizations (AOs) through a collaborative auditing approach, verifying compliance with regulatory standards across multiple countries in a single review. St.Shine Optical obtained MDSAP certification in 2019, actively showcasing our commitment to international regulatory compliance and our capabilities for expanding into overseas markets.