6th Joint Conference of Taiwan and Japan on

Medical Products Regulation

Strategies for Regulatory Convergence

including Asian Region
Cheng-Ning Wu
Taiwan Food and Drug Administration (TFDA)

October 11, 2018

Tokyo

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 Content

• Overview of TFDA’s major international activities

in:
– AHWP (Work Group 2 – Pre-market: IVD)
– APEC (LSIF-RHSC)
• including general introduction, participation
outcomes, future work plans and strategies
• in relation to the above organizations

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 AHWP (1/2)
Totally, 31 Member Economies
In Asia, Africa, Middle-East, Latin America

Kazakhstan Mongolia Bahrain Oman

United Arab Zimbabwe Kenya

Emirates

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 AHWP (2/2)

 Asian Harmonization Working Party (AHWP) is established as

a non-profit organization.
 Its goals are to study and recommend ways to harmonize
medical device regulations in the Asian and other regions and
to work in coordination with the Global Harmonization Task
Force, APEC and other related international organizations
aiming at establishing harmonized requirements, procedures
and standards.
 The Working Party is a group of experts from the medical
device regulatory authorities and the medical device industry.
 Membership is open to those representatives from the Asian
and other regions that support the above stated goals.

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 Participation in AHWP

 AHWP TC WG2 – Pre-market: IVDD

 TFDA holds the WG2 Chair position for 3 consecutive
terms (starting from 2012 till present)
 TFDA organizes 4~5 face-to-face and teleconference
working meetings per year to discuss and conduct
WG2 work plan

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 Outcomes in AHWP (1/2)

AHWP guidance/reference documents developed and endorsed by AHWP

 In 2012-2014 :

– AHWP/WG1a/F001:2013 AHWP Regulatory Framework for IVD

Medical Devices
– AHWP/WG1a/F002:2013 Essential Principles of Safety and
Performance of IVD Medical Devices
– AHWP/WG1a/F004:2013 Comparison between the GHTF Summary
Technical Documentation (STED) formats for Medical Devices and
In Vitro Diagnostic Medical Devices and the Common Submission
Dossier Template (CSDT) format
– AHWP/WG2-WG8/F002:2014 Role of Standards in the Assessment
of Medical Devices
– AHWP/WG2/F001:2014 Comparison between CSDT and STED
IVDDs

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 Outcomes in AHWP (2/2)

AHWP guidance/reference documents developed and endorsed by AHWP

 In 2015-2017 :

– AHWP/WG2-WG1/F001:2016 Definition of the Terms “Medical

Device” and “In Vitro Diagnostic (IVD) Medical Device”
– AHWP/WG2/F003:2016 Submission Dossier for Demonstrating
Conformity to the Essential Principles of Safety and Performance of
In Vitro Diagnostic Medical Devices
– AHWP/WG2/F002:2016 Principles of Conformity Assessment for In
Vitro Diagnostic (IVD) Medical Devices
– AHWP/WG2/F001:2016 Principles of In Vitro Diagnostic (IVD)
Medical Devices Classification
– AHWP/WG2/WD001:2017 Guidance for Additional Considerations
to Support Conformity Assessment of Companion In Vitro
Diagnostic Medical Devices

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 Future Strategy & Work Plan in AHWP

(2018-2020)
 Strategy
Develop AHWP guidance Provide recommendations to
documents implement regulatory framework

Participate in international Expand contributions in AHWP to

organization collaborations the globe

 Work plan
– Develop AHWP guidance documents
 Labelling for in vitro diagnostic medical devices (IVDs)
 Change management for medical devices (including IVDs)
 Approval of reagent for instrument family
– Collaborate with international organizations
 Recommendations provided to WHO IVD PQ program guidance
 Representation to participate in ISO/TC 212/WG3 technical meetings

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 APEC (1/3)

 21 member economies

Source: http://www.egeda.ewg.apec.org/egeda/about

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 APEC (2/3)

APEC Structure:
Leaders Meeting

APEC Business Sectoral Ministerial

Ministerial Meeting
Advisor Council Meetings

Senior Officials
Meeting (SOM)
APEC Secretariat

Committee on Trade Budget and Economic SOM Steering

and Investment (CTI) Management Committee Committee on
Committee (BMC) (EC) ECOTECH (SCE)
17 fora
Policy Level
Life Sciences and Working Level
Regulatory Harmonization
Innovation Forum
Steering Committee(RHSC)
(LSIF)
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 APEC (3/3)

As of August 2018, the current list of “Priority Work Areas”

(PWAs) approved by APEC LSIF-RHSC is as follows:
 Multi-regional Clinical Trials (MRCT), merged with Good
Clinical Practices (GCP) Inspection
 Medical Product Quality and Supply Chain Integrity
 Biotherapeutics (Biotechnological Products)
 Good Registration Management (Good Review Practices
(GRevP), merged with Good Submission Practices)
 Pharmacovigilance
 Advanced Therapies
 Medical Devices

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Participation in APEC LSIF-RHSC

Roles in RHSC
• GRM roadmap co-champion
• GRM CoE hosting institution

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Current Outcomes & Future Strategy in RHSC

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 Future Work Plan in RHSC (1/2)

On 2018/9/3, RHSC circulated a draft on Medical Device PWA roadmap:

 Lead Economies

– USA
– Japan
– Korea
 Structure
– Co-Champions
– Sub-Champions
– Centers of Excellence (CoE)
 Convergence Target
– Premarket
– Quality Management System (QMS)
– Postmarket

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 Future Work Plan in RHSC (2/2)

TFDA plans to support RHSC’s Medical Device PWA:

 Look into the possibility of becoming a sub-
champion/CoE under Medical Device PWA
 Work with co-champions (U.S. FDA, Japan PMDA, and
Korea MFDS) for endorsement of potential topic
 Collaborate with interested partners to carry out
capacity training for APEC member economies
 Help to advance RHSC’s vision of achieving regulatory
convergence for medical products by 2020

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Thank You

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