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Unchanged Regulatory Process for DXA-BMD Device Approval Makes it Easier for Market Adoption
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This study carries Frost & Sullivan’s observation of bone mineral density solutions in select Asian Countries (Australia, South Korea, and China); the regulatory trends for the same have been covered, highlighting the following:• Product registration and regulatory approval process details in select Asian countries (such as the Therapeutic Goods Advertising (TGA) approval for Australia, the China Food and Drug Administration (CFDA) approval for China, and the Ministry of Food and Drug Safety (MDFS) approval for South Korea)• Regulatory requirements for product registration for the DEXA-BMD device in Australia, China, and South Korea (including preclinical amendments, new clinical trials requirements according to country-specific and beta-testing documents, and device classification documentation) o During the country approval and product registration process, the original equipment manufacturer (OEM) need to submit the product clinical evaluation summary reports of the BMD device to verify the safety and performance of the DXA-BMD products, along with the technical file documentation or design dossiers, to the regulatory bodies.• Phantom testing, including the calibration and quality check for the DEXA-BMD device in evaluating the accuracy levels for targeted compositions (spine, lumbar, and peripheral) o When performing BMD testing with DXA systems, a quality analysis program is required to be implemented for guaranteeing any observed density changes and to validate that the changes are real and are not due to machine or operator variability.• Prevalence of osteoporosis and fracture incidence data in the respective countries (Australia, China, and South Korea)• Recommended Young Adult Mean (YAM) for bone mineral density in the countries of Australia, China, and South Korea
Key Issues Addressed
Author: Srikanth Kompalli
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