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?
- Key Findings
- Key Questions this Study will Answer
DXA-BMD Device-Product Registration and Regulatory Requirements
- Process Guidelines for DXA-BMD Device Regulation in Australia
- Registration Process for DXA-BMD Device in Australia
- Clinical Trial Documentation and Conformity Assessment for DXA-BMD Device in Australia
- Registration Process for DXA-BMD Device in China
- Registration Process for DXA-BMD Device in South Korea
Osteoporosis Definitions, BMD Prevalence, Incidence Overview, and Recommended YAM
- Osteoporosis Diagnosis and BMD Measurement
- Prevalence of Osteoporosis and Fracture Incidence and Recommended YAM
Phantom Testing and Documentation Needs
- Phantom Testing
- Key Quality Control Tests for DXA-BMD Devices
- Documentation Needs/Equipment Specification for DXA Bone Densitometer
- Legal Disclaimer
- List of Exhibits