MGI gene sequencing company

Location:Home / About MGI
Standard


MGI is well-established in the product certification qualification system. As a major global company of the industry, it also plays an important role in leading industry standards.

Since its establishment, many products of MGI were the first to receive approval for use in the market. For example, DNBSEQ-T7 was the first to receive emergency approval from the National Medical Products Administration during the epidemic,and MGIUS-R3 became the first remote ultrasonic equipment approved for listing.


1、With regard to qualifications, MGI’s products have obtained more than 140 certifications such as China NMPA, which is similar to FDA, and overseas CE, CB, cTUVus, EAC, etc., and other qualifications in many major markets such as Asia Pacific, EU, Russia, North America, and Central Asia.

2、With regard to certifications, MGI has obtained various standard system certifications such as ISO 13485 medical device quality management system, ISO 14001 environmental management system, ISO 27001 information security management system, BS OHSAS 18001 China ccupational health and safety management system.

3、 In terms of standards, MGI has comprehensive standards, covering three aspects: birth, aging and disease, and it is also committed to promoting the establishment of industry databases. Besides, MGI has participated in the formulation and release of 14 standards and industry  guidelines such as ”High-throughput Sequencing Data Sequence Format Specification” and formulated 13 national standard substances, and actively promoted the industry standards.