2. Medical Devices Quality Management System in Agnitio
CHEN, Chichen
Auditing Office

3. Medical Devices QMS Taiwan (ISO 13485:2003) International Standard
GMP, Pharmaceutical Good Manufacturing Practice Regulations (藥事法、藥物製造工廠設廠標準、藥物優良製造準則)
Medical Device Product Approval
International Standard
ISO 13485:2003
CE Marking for European Union

4. Product Approval in Taiwan
Risk Based Classification
Class I
Class II
Class III
Low Risk
GMP Required for Certain Categories
Medium Risk
GMP Required
High Risk
Product Approval
Product Approval Clinical Study Required for Certain Categories
Product Approval Clinical Data Required
Submission
Eg. BioIC Analyzer
Eg. BioIC Allergen Specific Ig E
Detection Kit
Eg. Blood Test: HBV HCV HIV

5. Implementation in Agnitio
TW GMP
2006: 1st Registration
2009: Reassessment
2012: Reassessment (every 3 years)
Registration No

6. Implementation in Agnitio
ISO By BSI British Standards Institution
2008: 1st Registration
Annual Reassessment
Registration No. MD525664

7. Implementation in Agnitio
TW Product Approval, 8 certificates
1 Class II: BioIC Allergen Specific Ig E Detection Kit
7 Class I: BioIC Analyzer / DNA Extraction Kit / Automatic Platform for Magnetic System
1 CE Marking: BioIC Allergen Specific Ig E Detection Kit
China : in process

8. Implementation in Agnitio
TW Product Approval
Class I: BioIC Analyzer
Registration No. DOH-MD-(I)-No

9. Implementation in Agnitio
TW Product Approval
Class II: BioIC Allergen Specific Ig E Detection Kit
Registration No. DOH-MD-No

10. Implementation in Agnitio
CE Marking: BioIC Allergen Specific Ig E Detection Kit

11. QMS Continuous Improvement of the Quality Management System Management
Responsibility
Client
Client
Measurement,
Analysis &
Improvement
Resource
Management
Satisfaction
Input
Output
Requirement
Product, Service
Realization
Product
Service
　　　　　Value Added Activities
　　　　　Information

12. Infrastructures Document Control Center
Management Representative: Dr. CHANG, Ping
Pluridisciplinaire Team (EE, ME, Bio, BME…)
Clean Room Facilities, Class 100K
In-House Setup for Manufacturing & QC

13. Continuous Improvement
Design Control / Risk Management ISO 14971: 2009
Monitoring & Measuring
Feedback from Customers
Analysis of Data
Corrective & Preventive Actions
Plan - Do - Check - Act

14. Thank you !!!