Unchanged Regulatory Process for DXA-BMD Device Approval Makes it Easier for Market Adoption
This study carries an 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)
- During the country approval and product registration process, the original equipment manufacturer (OEM) needs 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)
- 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
- What is the regulatory process for the DXA-BMD device to obtain TGA, CFDA, and MDFS approvals?
- How is DXA-BMD device registration done in Australia, South Korea, and China?
- What are the guidelines that OEMs need to follow for phantom testing and technical file documentation?
- What are the key quality control tests required for DEXA-BMD device approvals?
- What is the recommended YAM data for BMD measurements in Australia, South Korea, and China?
- What are the key documentation needs or equipment specifications for the product in the countries?
Table of Contents
Executive Summary
DXA-BMD Device-Product Registration and Regulatory Requirements
Osteoporosis Definitions, BMD Prevalence, Incidence Overview, and Recommended YAM
Phantom Testing and Documentation Needs
Appendix
Companies Mentioned (Partial List)
A selection of companies mentioned in this report includes, but is not limited to:
- China Food and Drug Administration (CFDA)
- Ministry of Food and Drug Safety (MDFS)
- Therapeutic Goods Advertising (TGA)
