Regulatory Trends in Select Asian Bone Mineral Density Solutions, 2017

Regulatory Trends in Select Asian Bone Mineral Density Solutions, 2017

Unchanged Regulatory Process for DXA-BMD Device Approval Makes it Easier for Market Adoption

RELEASE DATE
17-Jun-2019
REGION
Asia Pacific
Research Code: 9AB9-00-99-00-00
SKU: HC03185-AP-MR_23283

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Description

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

  • 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?

Author: Srikanth Kompalli

Table of Contents

Key Findings

Key Questions this Study will Answer

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 Diagnosis and BMD Measurement

Prevalence of Osteoporosis and Fracture Incidence and Recommended YAM

Phantom Testing

Key Quality Control Tests for DXA-BMD Devices

Documentation Needs/Equipment Specification for DXA Bone Densitometer

Documentation Needs/Equipment Specification for DXA Bone Densitometer (continued)

Documentation Needs/Equipment Specification for DXA Bone Densitometer (continued)

Documentation Needs/Equipment Specification for DXA Bone Densitometer (continued)

Legal Disclaimer

List of Exhibits

The Frost & Sullivan Story

Value Proposition—Future of Your Company & Career

Global Perspective

Industry Convergence

360º Research Perspective

Implementation Excellence

Our Blue Ocean Strategy

Related Research
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--BEGIN PROMO--

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?

Author: Srikanth Kompalli

More Information
No Index No
Podcast No
Author Srikanth Kompalli
Industries Healthcare
WIP Number 9AB9-00-99-00-00
Is Prebook No
GPS Codes 9600-B1,9837-B1,9614-B1