Lunit said Monday that its latest AI solution has obtained the Medical Device Single Audit Program (MDSAP) certificate, issued by five major countries after conducting one regulatory audit of a medical device.

The company will be partially or fully exempted from a duplicate regulatory procedure from the U.S. Food and Drug Administration (FDA), Health Canada, Japan Ministry of Health, Labor and Welfare (MHLW), Australian Therapeutic Goods Administration (TGA), and Brazilian Health Regulatory Agency (ANVISA).

Recently, the Canadian government strengthened requirements to allow only those who acquired MDSAP certificates for marketing medical devices in the home since 2019.

MDSAP is a system implemented by the International Medical Device Regulators Forum (IMDRF), certifying companies that have met safety and quality management standards through a single and coordinated audit of their medical devices.

The medical device market size in the five countries participating in MDSAP is estimated at $223.2 billion, accounting for about 55 percent of the global market.

“Our winning of the MDSAP certificate means the global recognition of the excellent quality management of our products,” Lunit CEO Suh Beom-seok said. “We will speed up advancing to the global market as our artificial intelligence-based solutions have laid the foundation for targeting the market.”

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.

The company recently obtained FDA clearance for Lunit Insight CXR Triage and Lunit Insight MMG for automatically classifying those with the emergency disease.

The company said it plans to continue expanding its solution lineup to include AI biomarker platform Lunit Scope and other AI software, such as Lunit Insight Chest CT and Lunit Insight DBT for breast tomography.