Certificates

As a trusted leader in genomics and medical technology, MGI has earned certifications that demonstrate our dedication to excellence and regulatory compliance worldwide. Our achievements empower research and clinical applications across continents.

• Over 434 product certifications covering 85+ products, empowering research and clinical markets in 90+ countries including China, Asia-Pacific, Europe, Africa, and the Americas.
• 41 gene sequencers approved by the China National Medical Products Administration (NMPA) for clinical use, with 24 based on MGI’s DNBSEQ™ core sequencing technology.

International Accreditations

• ISO 9001: Quality Management System
• ISO 13485: Medical Device Quality Management System
• MDSAP: Medical Device Single Audit Program Certification
• ISO 14001: Environmental Management System
• ISO 45001: Occupational Health and Safety Management System
• ISO 27001: Information Security Management System
• ISO 27701: Privacy Information Management System
• IECQ QC 080000: Hazardous Substances Process Management System

Leadership

MGI has led or contributed to 104 standards, spanning national, industry, group, enterprise, and “Belt and Road” regional levels. These standards cover genomics, medical devices, data security, and emerging technologies, shaping industry benchmarks globally. Key examples include:

• High-throughput Sequencing Data specifications for Human Genome interpretation
• Blockchain standards for Genomic Data circulation
• Remote Ultrasound Robot Operational standards
• PCR requirements for SARS-CoV-2 testing
• Automated nucleic acid extraction and purification system standards
• ESG disclosure and evaluation guidelines for medical devices

Data Security & Digital Standards

MGI ensures that user privacy and data integrity are at the forefront of its operations. Certified to ISO 27001 and ISO 27701, the company implements end-to-end security protocols across all data systems. In alignment with global data protection laws, MGI fully complies with the General Data Protection Regulation (GDPR), ensuring the lawful, transparent, and secure handling of personal and research data.

Commitment to Sustainability and Safety

MGI practices green manufacturing and sustainable innovation, reducing environmental impact through ISO 14001 and IECQ QC 080000 systems. Our certification to ISO 14067 further demonstrates MGI’s commitment to measuring, managing, and reducing the carbon footprint of its products throughout their life cycle. Employee health and safety are safeguarded through ISO 45001.

Global Milestones

• Over 3,100 users worldwide
• Celebrating more than 10 years of innovation, producing 10,000+ research articles
• Continuously upgrading product solutions, including the SEQ ALL “renewal” platform

Through these achievements, MGI continues to drive innovation, ensure regulatory compliance, and establish global industry benchmarks, embodying its philosophy: Excellence in Intelligent Manufacturing, Quality First.