DRGEM Obtains Class II MDL in Canada
DRGEM has obtained Class II Medical Device Licenses (MDL) from Health Canada under the Canadian Medical Device Regulations (CMDR, SOR-98-282) for five product groups across nine models.
Approved systems include:
- GXR-S/CS, Diagnostic X-ray System
- GXR-ES/ECS, Diagnostic X-ray System
- TOPAZ, Mobile X-ray System
- JADE, Mobile X-ray System
- AcquiDR, Digital Imaging System
This certification confirms that DRGEM’s products meet Canadian regulatory standards for safety and performance. It also improves access to the Canadian medical device market, thereby expanding commercial reach throughout the entire North American region, where regulatory compliance is essential for business growth.
“This Health Canada MDL certification demonstrates that DRGEM’s quality and technology are trusted globally,” said Mr. J.B. Park, President of DRGEM. “We will continue to meet regulatory standards and strengthen our global presence by earning the trust of our partners.”
With a wide range of systems now certified, including general, compact, and mobile X-ray solutions, DRGEM further enhances its global competitiveness and readiness to support diverse clinical environments.
