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2015 Annual Report

45

Risk Assessment

Management and

Research Outcomes

Cosmetics

Management

Appendix

National

Laboratory and

Testing Network

Risk Communication

and Consumer

Protection

International

Cooperation and

Cross-Strait Exchange

Food

Management

Medicinal

Products

Management

Policy and

Organization

Controlled

Drugs

Management

Medical

Devices

Management

5

Medical device industry is an emerging industry that carries lots of potential to be developed in a broad

array of dynamic and versatile medical fields. Facing with the vividness and quality management of

domestic medical device industry and the core emphasis on consumer protection, a total product life cycle

regulatory system (Figure. 5-1) covering international regulatory harmonization, production source control,

pre-market gatekeeping, post-market monitoring, supply chain management, and professional counseling

service was established to effectively ensure the safety, effectiveness, and quality of medical devices, as

well as to promote development of Taiwan's biotech and pharmaceutical industry, creating an environment

beneficial for consumers, the industries, and the government.

Section 1 Medical Device Regulations and Product Review

Current Status

The medical device industry is the one that requires highly strict regulatory requirements and

management. A transparent, effective, and appropriate regulatory environment must be established

in order to safeguard the safety of device usage for public and promote industrial development. To

strengthen management over medical device safety, effectiveness, and quality before market release,

management items for inspection and registration such as preclinical testing, clinical trials, and

product inspection standards are reviewed accordingly. Medical device industries are also provided

with regulatory inquiry and project consultation services for innovative research and development

applications, providing a strong foundation for their business development.

Production quality

system control

Medical Device Advisory Committee

Manufacturer’s Quality System Audit (GMP)

Consumer Health

Education Promotion

Safey Surveillance &

Alert Collection (GVP)

ADR & Product Defect Reporting

GLP

GTP

GCP

IRB

GMP

ADR

GVP

GDP

Good Laboratory Practice

Good Tissue Practice

Good Clinical Practice

Institutional Review Board

Good Manufacturing Practice

Adverse Drug/Device Reaction

Good Vigilance Practice

Good Distribution Practice

GDP

Post-market Surveillance

Postmarket Control

Medical Care

Needs/

Fundamental

Study

Product

Design/Prototype

Development

Preclinical

Validation

Clinical Trial

Premarket

Application

Postmarket

Surveillance

Production

General / Special

Case Consultation Good Laboratory

Practice

(GLP/GTP)

Product

Designation

Clinical Trial

Inspection (GCP)

Registration

(Approval/Listing)

Clinical Trial

Protocol Review

(TFDA/IRB)

Premarket

Control

Medical Devices Management

Figure 5-1

Medical device total product life cycle management system

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