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Lunit Obtains MDSAP Certificate, Granted Fast-Track Regulatory Process in Major Countries

Dec 27, 2021 - Lunit Media
  • Lunit meets MDSAP requirements as a global standard medical AI software manufacturer

  • QMS audit exemption in the US, Canada, Japan, Australia, and Brazil

Seoul, South Korea, Dec 27, 2021–Lunit, a leading AI software company for cancer screening and treatment, announced it has obtained MDSAP (Medical Device Single Audit Program) certificate.

The MDSAP, operated by International Medical Device Regulators Forum (IMDRF), is a global audit program that leverages regulatory resources to manage an efficient, effective and sustainable single audit program. 

A certified manufacturer is allowed for a single quality management system audit in place of multiple audits for five countries, including the United States (FDA), Canada (Health Canada), Japan (MHLW), Australia (TGA), and Brazil (ANVISA). The certification is considered evidence of a medical device manufacturer’s commitment to product quality and regulatory compliance.

In 2021, FDA said it would accept MDSAP audit reports as a "substitute" for routine agency inspections. In 2019, the Canadian government strengthened market requirements to allow only those who acquired MDSAP certificates.

According to the Korea Health Industry Development Institute, the medical device market size in the above five countries is estimated at USD 223.2 billion, which makes up about 55 percent of the global medical device market.

“MDSAP certificate signals global recognition for an excellent quality management of our products,” said Brandon Suh, CEO of Lunit. “We are looking forward to speeding up global market expansion with our AI solutions both currently commercialized and in the pipeline.”

Lunit INSIGHT CXR for chest X-ray images and Lunit INSIGHT MMG for mammography are already used at 450 medical institutions in 38 countries worldwide.

Lunit has recently obtained FDA clearance for Lunit INSIGHT CXR Triage for emergency disease triage and Lunit INSIGHT MMG for breast cancer detection.

Lunit plans to expand its solution lineup to include the AI biomarker platform Lunit SCOPE and other AI software, such as Lunit INSIGHT Chest CT and Lunit INSIGHT DBT for breast tomography.

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