Medical DevicesQuality Management

System in AgnitioCHEN, Chichen

Auditing Office

Medical Devices QMS

• Taiwan (ISO 13485:2003)– 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

Product Approval in Taiwan

Class I Class II Class III

Low RiskGMP Required for Certain Categories

Medium RiskGMP Required

High RiskGMP Required

Product Approval Product Approval Clinical Study Required for Certain Categories

Product Approval Clinical Data Required

• Risk Based Classification

Eg. BioIC AnalyzerEg. BioIC Allergen Specific Ig E

Detection KitEg. Blood Test: HBV HCV HIV

Submission

Implementation in Agnitio

• TW GMP – 2006: 1st Registration– 2009: Reassessment – 2012: Reassessment

(every 3 years)

Registration No. 1015060972

Implementation in Agnitio

• ISO 13485 By BSIBritish Standards Institution– 2008: 1st Registration– Annual Reassessment

Registration No. MD525664

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

Implementation in Agnitio

• TW Product Approval– Class I: BioIC Analyzer

Registration No.DOH-MD-(I)-No.001997

Implementation in Agnitio

• TW Product Approval– Class II:

BioIC Allergen Specific Ig E Detection Kit

Registration No.DOH-MD-No.002717

Implementation in Agnitio• CE Marking:

BioIC Allergen Specific Ig E Detection Kit

QMS

ManagementResponsibility

Resource Management

Measurement, Analysis &

Improvement

Product, ServiceRealization

ProductService

Client

RequirementOutput

Satisfaction

Continuous Improvement of the Quality Management System

　　　　　　 Value Added Activities　　　　　 Information

Client

Input

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

Continuous Improvement

• Design Control / Risk Management ISO 14971: 2009

• Monitoring & Measuring

• Feedback from Customers

• Analysis of Data

• Corrective & Preventive Actions

Plan - Do - Check - Act

Thank you !!!