Chinese Taipei Regulatory Update

Division of Medical Devices and Cosmetics, TFDA

December 2020

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TFDA Organization Chart

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 Medical Device Regulatory Framework

Quality System
• Beginning of registration: 1973
Management
(GMP/QSD) • GMP* implementation: 1999

• Reclassification: 2000
• No. of registered MD licenses:
46,711 (as of 2020)
Postmarket Medical Premarket
Surveillance Registration (75% Imported; 25% Domestic)
Devices
• No. of registered MD manufac-
turers: 1,649 (as of 2019)

Distribution
Management *ISO 13485 adopted

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 Medical Device Life Cycle Management
Product
Design/ Preclinical Clinical Premarket Produc- Postmarket
Prototype Validation Study Application tion Surveillance
Development

General/Advanced Laboratory Clinical Trial Premarket Postmarket

Consultation Practices Inspection
(GLP) (GCP) Control Control
Product
Designation Clinical Study
Protocol Registration
Review (Approval/
(TFDA/IRB) Listing)

MD Advisory Committee
Manufacturer’s Quality System (GMP)

ADR & Product Defect Reporting

GLP ：Good Laboratory Practice
GCP：Good Clinical Practice Safety Surveillance &
IRB： Institutional Review Board Alert Collection (GVP)
GMP：Good Manufacturing Practice Consumer Health
ADR：Adverse Drug/Device Reaction Education Promotion
GVP：Good Vigilance Practice Good Distribution Practice (GDP)
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Basis of Medical Device Regulation

 Pharmaceutical
Affairs Act Act
 Medical Care Act

 Reg. for Governing the Management of Medical Devices

 Reg. for Registration of Medical Devices
 Reg. of Medicament Manufacturer Inspection Regulation
 Reg. for Medicament Contract Manufacture and Analysis
 Reg. for Safety Monitoring of Medicaments
 Reg. for Reporting Serous Adverse Reactions of Medicaments
 Reg. for Medicament Recall

 Guidance for Premarket Registration

 Good Clinical Practice (GCP)
 Guidelines for Registration of IVD Guidance
 Good Laboratory Practice (GLP)
 Recognized International Standards

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 Risk Based Regulation

Low risk High risk

GMP/QSD GMP/QSD GMP/QSD

Class 1 3 Classes
Class 2
Class 3
Affidavit Technical
On-site Document Technical
registration Document
Preclinical testing, Documents
QC documents required for
and clinical trial registration
reports
*QSD: Quality System Documentation

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 Medical Device Categories

A. Clinical Chemistry and Clinical Toxicology Devices

B. Hematology and Pathology Devices IVD
C. Immunology and Microbiology Devices
D. Anesthesiology Devices
E. Cardiovascular Devices
F. Dental Devices
G. Ear, Nose, and Throat Devices
H. Gastroenterology-Urology Devices
16 Categories
I. General and Plastic Surgery Devices
J. General Hospital and Personal Use Devices
K. Neurological Devices
non-IVD
L. Obstetrical and Gynecological Devices
M. Ophthalmic Devices
N. Orthopedic Devices
O. Physical Medicine Devices
P. Radiology Devices

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 Premarket Registration

Manufacturing Facility Product

GMP/QSD Application License Application

DAO: designated auditing organization TFDA

Class 1/2/3
DAO Auditing

Medical Device
Review Center
TFDA Advisory Committee
(Document Review)
(new devices)

GMP/QSD Compliance
Letter
License Issuance

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 Postmarket Surveillance
Manufacturer
• Adverse event / product defect
• Clinical trial adverse event
• Periodic Safety Update Report (PSUR)
• Voluntary recall notification
Asian Harmonization Working Party (AHWP)
Local Health Authority Safety Alert Dissemination System (SADS)
• Investigation, seizure, and
sampling of non-compliant REPORTING
product Active surveillance of
international postmarket
Consumer & Medical Personnel
safety information
• Adverse device reaction (ADR)
• Product defect

TFDA
Medical Device
Recall
Support Analysis

National ADR
Reporting Center

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 Medical Devices Act (MDA)

⚫ 2020-01-15 promulgated by Presidential Order

⚫ Establishing a separate act for a globally harmonized
medical device regulation
⚫ Perfecting the regulatory system of medical device
total product life cycle
Enhance
Advance regulation of Strengthen flow &
development diversified distribution
& innovation technologies management

Fulfill regulation
by risk Set up clinical Reinforce post-
classification trial framework market regulation

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 Key Points of Policy Administration
MDA Premarket Post-market
Clinical Trial
Implementation Control Control
• Draft 22 • Optimize review • Build a platform • Establish
supporting process & of eClinical trials mechanisms to
subsidiary develop management regulate the
regulations & regulatory system source and flow
promulgate 18 practices for of implanted
announcements emerging MDs MD products

Distribution Industry International

Management Assistance Cooperation
• Promote Unique • Improve search • Participate
Device of potential case actively in
Identification sources & early- international
(UDI) System stage regulatory organizations &
assistance establish bilateral
agreements

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