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Asia – Europe MedTech Market Access

Your end-to-end partner to certify, launch and sell MedTech across borders

From Asia into Europe, and from Europe into Asia. Market feasibility, EU/HK/US MedTech product registration, import, license holding, commercial outsourcing and distribution — under a single accountable partner.

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100+Authorizations secured
50+Clients served
7 yrsEU regulatory practice
Hong Kong European Union
  • EU MDR 2017/745
  • EU IVDR 2017/746
  • ISO 13485:2016
  • US FDA
  • HK MDCAS
  • EU-REP / HK LRP
Core services

From feasibility to in-market sales

Eight services covering the full journey — assess, validate, certify, import and sell, in either direction between Asia and Europe.

Market feasibility & commercial assessment

An independent, costed evaluation of whether your product can realistically sell in Europe — commercial viability, pricing and regulatory strategy before you commit resources.

Distribution partnerships

We connect APAC manufacturers with European distributors and buyers, support negotiation and secure committed channel partners before you invest in full certification.

EU product registration

The entire EU registration process — technical file development, ISO 13485 QMS implementation and notified body coordination, through to CE-marking and market placement.

Hong Kong product registration

Voluntary device listing under Hong Kong's MDCAS — classification, technical documentation and Local Responsible Person services for manufacturers landing in HK.

US FDA registration & clearance

US market entry through establishment registration, device listing and the right premarket pathway via our US partner network — including US Agent representation and QMS alignment.

EU / HK import & authorized representation

We act as your EU importer and Authorised Representative, and your HK importer and Local Responsible Person — assuming post-market surveillance, vigilance and compliance responsibility.

Product sourcing & EU sales channel

Sourcing of semi-finished and finished MedTech products from APAC manufacturers, distributed to EU buyers — a ready, compliant sales channel with no local establishment of your own.

Third-party audits & due diligence

Independent technical and regulatory audits of manufacturers on behalf of EU partners — and vice versa — covering compliance, quality systems and overall risk profile.

Our platform
TechFile.co The technical documentation platform behind our technical file practice.
Visit TechFile.co
Why GATE-U

What sets us apart

A consultancy pairing deep regulatory expertise with real commercial outcomes across Asia, Europe and the US.

Track record

Proven across 100+ authorizations

Seven years of hands-on EU regulatory practice for more than fifty manufacturers — experience that shows in every submission.

Commercial first

Demand before certification

We validate real commercial demand and secure committed distribution partners before you invest in certification — a costed go/no-go decision, not a leap of faith.

Ownership

One partner, every market

From feasibility to import, license holding and post-market compliance — a single accountable partner across the EU, Hong Kong and the US.

Our mission

The most reliable gateway between Asia's and Europe's MedTech markets.

We give manufacturers on both sides a stable, expert platform to certify, launch and sell across borders.

Let's make things happen
Client journey

A step-by-step path to market

A collaborative process, designed around your product, your target markets and your timeline.

1

Free consultation

A no-cost call to understand your product, your goals and your status quo — the foundation of a path we shape entirely around you.

2

Feasibility & roadmap

We assess whether and where your MedTech product can realistically be sold in Europe or APAC, then agree a costed go/no-go decision and a clear market-entry roadmap.

3

Commercial validation & distribution

We test real demand and connect you with qualified European distributors and buyers — helping you secure commercial traction before you invest in certification.

4

Multi-market registration

We build your technical file and ISO 13485 QMS and steer registration across the EU, Hong Kong and the US — depending on your target market and entry strategy — until you receive clearance from the authorities.

5

Import & license holding

Depending on your target market, we act as your EU / HK importer and Authorized Representative or Local Responsible Person — taking your MedTech live and accountable in-market.

6

Ongoing compliance & training

Post-market surveillance, vigilance, renewals and independent audits keep you compliant — and we upskill your team so compliance becomes an internal capability.

Case studies

Practical experience, across project types

A selection of anonymized engagements from our recent work.

Class Is–III · Non-active devices · EU

EU market access for an established Israeli manufacturer of non-active medical devices

Client
Mid-sized Israeli OEM manufacturer of non-active surgical devices with a Class Is–III portfolio, seeking entry to the EU.
Project
EU market access for the portfolio, with no in-house EU MDR or Notified Body expertise, tight timelines to maintain sales momentum overseas, and a need for an EU REP to begin market entry via CE-mark.
Scope & milestones
  • Temporary role as EU REP to allow entry into the EU market
  • Technical documentation brought in line with EU MDR across the device groups
  • Notified body selection, submission and deficiency response managed to close-out
Expertise provided
EU Authorised Representation, EU MDR gap analysis and technical file development, notified body coordination, project lead through to certification.
Successful CE-marking with TÜV SÜD for 7 medical device groups
Class IIb · Active device · EU

APAC manufacturer to CE-mark

Client
APAC manufacturer of an active monitoring device, with no established presence in Europe.
Project
EU market access for the device through CE-marking under MDR 2017/745.
Scope & milestones
  • Technical file rebuilt to MDR requirements
  • ISO 13485 quality management system implemented
  • Notified body review coordinated and deficiencies resolved
Expertise provided
Technical documentation, QMS implementation, notified body coordination and deficiency response, project lead throughout.
CE certificate achieved — device placed on the EU market
IVD · Feasibility · EU entry

Go/no-go before certification spend

Client
IVD manufacturer weighing whether EU entry justified the certification investment.
Project
Market feasibility and commercial assessment ahead of an EU entry decision.
Scope & milestones
  • Commercial viability and pricing analysis across the target EU markets
  • Costed go/no-go decision with a focused market-entry roadmap
  • Distributor search, introduction and negotiation support
Expertise provided
Market feasibility, pricing and regulatory strategy, distribution partnerships.
Distribution agreement signed before certification investment
EU manufacturer · Hong Kong

European device into the HK market

Client
European manufacturer expanding into Asia, needing a compliant route into Hong Kong.
Project
Voluntary MDCAS listing and ongoing local representation in Hong Kong.
Scope & milestones
  • Device classification under the Hong Kong MDCAS framework
  • Technical documentation compiled and listing application managed
  • Local Responsible Person role assumed in-market
Expertise provided
HK regulatory strategy, technical documentation, Local Responsible Person services, post-market obligations.
Listed with the HK Medical Device Division — selling in Hong Kong
Team

The people behind the gate

Experienced regulatory and operations specialists who guide you personally — at every step.

Michal Pallo

Michal Pallo

CEO, Co-Founder
Business Development SEA (Hong Kong)

10+ years of experience as MedTech consultant in Denmark, and Austria. Leads business development and client partnerships across the GBA. Expert in EU and HK regulatory landscape with experience in cross-border commercialization. Connector of people, skilled at translating customer needs into clear, actionable plans and closing deals across cultures.

Non-active devices Substance-based devices Drug-device combinations
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Jozef Kováč

Jozef Kováč

COO, Co-Founder
Business Development Europe (Slovakia)

20+ years of experience in medical device industry. Leads the European operations, founder of MDRC s.r.o., leverages extensive network of EU manufacturers, distributors, notified bodies, expert in Central Europe market entry strategies and regulatory compliance, with practical experience in manufacturing. Supports HK MDCAS listing.

Active devices Medical device software
Connect on LinkedIn
Operations team
Katarína Poláková
Katarína PolákováConsultant · Medical Devices & Digital Health

5+ years in medical device regulatory affairs, focused on EU MDR and digital health. Builds technical documentation for EU market access with a structured, detail-driven approach.

Zuzana Holková
Zuzana HolkováConsultant · Medical Devices & Clinical Affairs

8+ years in device regulatory and clinical affairs, with deep EU MDR and post-market surveillance expertise — including technical documentation and submissions for Class III implantable devices.

Philip Choy
Philip ChoyBusiness Development & Partnerships

30+ years in market development and business integration across Asia, with long-standing relationships spanning the healthcare, finance and technology sectors.

Partners
Dr. Bjorn Hammarberg
Partner firm
Dr. Bjorn Hammarberg
ABD Lifesciences

GATE-U works with ABD Lifesciences as an independent partner firm on selected engagements.

Clients & partners

Former clients and current partners

A selection of the organizations we've worked with across Asia and Europe.

Get in touch

Begin your market-access journey today

Tell us about your product and your target markets. We'll map the fastest compliant route — starting with a free consultation.

Book a free consultation
Email
info@gateu.hk
Phone
+852 9472 0986
Office
Unit 1603, 16/F, The L. Plaza,
367–375 Queen's Road Central,
Sheung Wan, Hong Kong SAR