Certification
LAGIS strictly adheres to international medical device regulations, establishing a robust quality management system. We have obtained numerous international quality certifications, including Taiwan "QMS," "ISO 13485:2016," EU "MDR 2017/745," UK "UK MDR 2002," and the multi-country "MDSAP." Furthermore, our proprietary products have secured marketing authorizations in Taiwan, Japan, the EU, the UK, the USA, and many other countries. Our quality performance is highly recognized in the international market, continuously strengthening corporate product responsibility and global trust.
- Certified by EU MDD (93/42/EEC); secured European market access
- Certified by Japan PMD Act; secured Japan market access
- Certified by US FDA (510k); secured USA market access
- Certified by Korea KGMP; secured South Korea market access
- Certified by Brazil ANVISA GMP; secured Brazil market access
- Certified by Australia TGA; secured Australia market access
- Certified by China NMPA (CFDA); secured China market access
- Certified by Canada CMDCAS; secured Canada market access
- Certified by Malaysia MDA; secured Malaysia market access
- Certified by Singapore HSA; secured Singapore market access
- Completed transition to Quality Management System ISO 13485:2016
- Obtained CE Certificate from BSI
- Certified by Serbia ALIMS; secured Serbia market access
- Implemented Material Flow Cost Accounting (MFCA) system
- Trocar obtained BSI Class IIa MDR Certificate
- TR, TRO, and TRE secured Albania marketing authorization
- EB, EBH, and SI secured Brazil marketing authorization
- Completed product transition from MDD to MDR certification
- Certified by ISO 14001 EMS and MDSAP