Certification

LAGIS strictly complies with medical device regulations of various countries and has established a robust quality management system. The company has obtained multiple international quality management system certifications, including Taiwan’s QMS, the international standard ISO 13485:2016, the European Union’s MDR 2017/745, the United Kingdom’s UK MDR 2002, as well as the multinational MDSAP certification. Furthermore, LAGIS’s own products have obtained market approvals in Taiwan, Japan, the EU, the UK, the USA, and other countries. The quality performance has received high recognition in the international market, continuously strengthening the company’s product responsibility and global trust.

• Certified under the European Union MDD (93/42/EEC), obtaining European sales approval

• Certified under Japan PMD Act, obtaining Japanese sales approval

• Certified under the U.S. FDA (510k), obtaining U.S. sales approval

• Certified under Korea KGMP, obtaining Korean sales approval

• Certified under Brazil ANVISA GMP, obtaining Brazilian sales approval

• Certified under Australia TGA, obtaining Australian sales approval

• Certified under China CFDA, obtaining Chinese sales approval

• Certified under Canada CMDCAS, obtaining Canadian sales approval

• Certified under Malaysia MDA, obtaining Malaysian sales approval

• Certified under Singapore HSA, obtaining Singaporean sales approval

• Completed ISO 13485:2016 quality management system transition

• Obtained BSI CE certificate

• Certified under Serbia ALIMS, obtaining Serbian sales approval

• Implemented Material Flow Cost Accounting (MFCA) system

• Trocar obtained BSI Class IIa MDR certificate

• TR, TRO, and TRE obtained Albanian sales permits

• EB, EBH, and SI obtained Brazilian sales permits

• Completed product transition from MDD to MDR certification

• Certified under ISO 14001 Environmental Management System and passed MDSAP certification