Professional Documents
Culture Documents
December 2020
1
TFDA Organization Chart
2
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
3
Medical Device Life Cycle Management
Product
Design/ Preclinical Clinical Premarket Produc- Postmarket
Prototype Validation Study Application tion Surveillance
Development
MD Advisory Committee
Manufacturer’s Quality System (GMP)
4
Basis of Medical Device Regulation
Pharmaceutical
Affairs Act Act
Medical Care Act
5
Risk Based Regulation
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
6
Medical Device Categories
7
Premarket Registration
Medical Device
Review Center
TFDA Advisory Committee
(Document Review)
(new devices)
GMP/QSD Compliance
Letter
License Issuance
8
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
9
Medical Devices Act (MDA)
Fulfill regulation
by risk Set up clinical Reinforce post-
classification trial framework market regulation
10
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
11