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Navigating European Union (EU) Medical Device Compliance: Pathways to Market Access and Regulatory Success in EU Market

Event Details

Date

28 July 2026

Time

09:30 - 11:30

Venue
Join Onsite

Classroom 126, 1/F, HKPC Building, 78 Tat Chee Avenue, Kowloon

Language

English

Target

MedTech startups, SMEs, regulatory affairs professionals, and exporters eyeing EU market

Registration Fee

Free

EU Medical Device Compliance Seminar KV

About the Event

This seminar, “Navigating EU Medical Device Compliance: Pathways to Market Access and Regulatory Success in EU Market” delivers an essential strategic framework for APAC MedTech companies aiming to penetrate the dynamic EU market. Participants will understand the regulatory pathways, learn the requirements in MDR, IVDR etc., accelerate market entry and commercial success in this region.

Honourable Speakers

Mr. Michal Pallo

Mr. Michal Pallo

CEO and Co-Founder

GATE-U Limited 

Ir Patrick Tham

Ir Patrick Tham

Consultant, Mechatronics Engineering

Advanced Industries Development

New Industrialisation Division

Hong Kong Productivity Council

Agenda

9:30 - 9:40

Welcome Speech & Introduction to HKPC

Ir Patrick Tham

9:40 – 10:20

Navigating the EU Medical Device Regulatory Landscape: Medical Devices Regulation (MDR), In Vitro Diagnostics Regulation (IVDR) and CE-Marking Pathways

Mr Michal Pallo

10:20 – 10:30

Networking Break

10:30 - 11:10

Strategic EU Medical Device Registration and Market Entry: From Compliance to Commercial Readiness

Mr Michal Pallo

11:10 - 11:30

Driving Industry Innovation: How HKPC Supports Life and Health Industry Development

Ir Patrick Tham

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Sponsors

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Supporting Organisations (in no particular order)

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Disclaimer:​​
Any opinions, findings, conclusions or recommendations expressed in this material/event (or by members of the project team) do not reflect the views of the Government of the Hong Kong Special Administrative Region or the Vetting Committee of the Trade and Industrial Organisation Support Fund.

Enquiry:
Ir Patrick Tham | +852 2789 5131 | patricktham@hkpc.org
Mr Ronnie Chea | +852 2782 8427 | ronniechea@hkpc.org

Event Registration Form
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