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ARQon International Business Group

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Regulatory & Quality
B2B Global Medical Community
Commercialisation 
Training
ARQon International Business Group specializes in Regulatory consultancy, Commercial advisory, Training and Digital platform to support companies to gain global market access. 
Our team combines industry and ex-regulator experiences, local networks and relationships to navigate your regulatory and market objectives to develop a solid strategy for your market access as we understand regulatory fast track and requirements for your product type. We present globally to serve your different needs.
why arqon
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Why ARQon

 Product Expertise & Experience

Medical device, IVD, therapeutic, complementary health & cosmetic products.

Global Market Access

Provide an efficient pathway to bring your product to the market with our global presence.

Cost Effective & Strategy Approval

Help to meet your business needs & goals quickly & effectively.

Compliance for patient safety

Support clients to ensure regulatory compliance & quality of  products.

Latest & reliable resources

Free latest updates and regulatory news in our website. 

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ARQon Group's Presence

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ARQon
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SINGAPORE
MALAYSIA
TAIWAN
VIETNAM
SWITZERLAND
HONG KONG
SOUTH KOREA
INDONESIA
PHILIPPINES
THAILAND
INDIA
MedtechBOSS
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SINGAPORE
ATTOPOLIS
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SINGAPORE
IMDS
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SINGAPORE
MALAYSIA
CHINA
SOUTH KOREA
EUROPE
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ARQon Management Team

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May Ng
Group CEO

• Founder of ARQon Group, MedTechBOSS, IMDS, ATTOPOLIS B2B (8 years)

• Product Manager for IVDs, Poison & Radiation device (2 years)

• Singapore Health Science Authority (HSA) regulation implementation & MEDICS lead, approved 1400 devices & dealers, key author guidances CSDT & GDPMDS (10 years)

• Biosensors, Regulatory Director drug eluting stent in Manufacturing Site for Global approval, Technical Fille & audit (4 years)

• Advisor for SG (NHIC, ASTAR, IPI), Korea (KHIDI), Ministry of Law’s COVID Assessor, US-ASEAN Regulatory Group, International Speaker (Medica Asia, MEDICA Düsseldorf, Medtech Summit Europe)

• Past: ASEANMed Co-chair, Singapore Manufacturing Federation Council, Medtech Industry Capability Development & Youth chair, US-China ASEAN Medical Cooperation Committee, AHWP, ASEAN MDPWG, Trainer for Regulators, Prime Minister Office’s Tech Assessor

MANAGEMENT DIVISIONS

Julie Dao
Global Business Director
ATTOPOLIS
Ray Soh
Global Regulatory Director
REGULATORY, Device
Dr Wong Tee Wee
Global Regulatory Director
REGULATORY, Drugs
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Al
Corporate Expansion Director
COMMERCIAL, Global
Shaun Kho
Quality & Tech Director
QUALITY & TECH
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Patrick
Legal Advisor
LEGAL
Basil
Global Market Director
COMMERCIAL, Europe
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Dev
APAC Market Director
COMMERCIAL, Asia
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Ashok Kapur
Global Market & IT Advisor
COMMERCIAL & IT, US

FUNCTIONAL OFFICES

Bing Kang
Senior Administrator
OPERATION
Ann
Business Analyst 
BUSINESS & FINANCE
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Afif
Regulatory & Quality Associate
REGULATORY & QUALITY
Kah Suan
Project Coordinator
PROJECT MANAGER
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Trish Alveinto
PA to CEO
SECRETARIAT
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Kai Li
Regulatory Affairs Associate
REGULATORY & QUALITY 
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ARQon Group's Services

Product Registration

  • Asia/ASEAN, EU, US & GLOBAL (Medical Devices, Therapeutic & Health Safety products)

  • Labelling & Brochure medical claims compliance

  • Post market vigilance reporting

License Holding

  • In-Country Product License Holder & Representative

  • CE Rep, UK Rep & UKCA Marking

Extra RA/QA Support

  • Regional regulatory monthly support

  • Quality management & maintenance

Drug Therapeutics

  • Product development for drug, biologics or combination drug-device products

  • Labelling / Packaging / Supply chain consultation

  • Health authority negotiations / Compliance support

Health Safety

  • Wireless, Radiation, Packaging compliance submission & approval
    in
    Asia/ASEAN, EU, US & GLOBAL

Batteries

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Wireless

Packaging

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Medical Device

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Drugs

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Cosmetics

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Health Supplements

Five Steps to Get Your Product to The Market

01

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Pre-evaluation (product classification, exemption, registration, documentation, & checklist)

Appoint in-country representative for the product

Product regulatory approval

03

05

02

Compilation of dossier or technical documents

04

Product registration by local marketing authorization holder

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Corporate Expansion

  • Provide business advisory on Company Set-up, Legal & Tax (Strategic Business, Accounting & IT solutions,  Risk Management & Assurance)

  • Regulatory / Quality setup & MOH licensing approval, Manufacturing plants plan & build) 

Global Market Strategy

  • Develop solid strategies for market access based on the product type

  • Market scanning and researching for a deep and  customised investigation for your products / services

Business Matching

  • Commercial advisory on Partner search in Asia/ASEAN, EU, US & GLOBAL (Distributor, CDMO/OEM, Tech Licensee)               

Technical Documentation

  • Helps new startups & existing companies develop a solid strategy, while providing consultancy services, directing them to international markets.

  • Quality advisory (Technical File, ISO13485, GMP, GDP, CE MDR, IVDR, Supplier audit)

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Manufacturers and Distributors

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Researchers

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Medical Institutions

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Start-ups

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Medtech Training

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International Medical Device School

• Once a year, 1-4 days training and networking in SG, China, KR, EU and MY, we provide an overall comprehensive knowledge on Product lifecycle from design, manufacturing, regulatory and quality, and commercialization to MedTech professionals. 

• Allows Medtech professionals to upgrade themselves and explore the advanced technologies in medical device, learn about market strategy opportunities and gain valuable insights from respected speakers in the field. 

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B2B Marketplace, Forum, News

• A B2B international medical platform that aims to lead, connect, and globalize MedTech Companies and Professionals.

• For professional companies (Manufacturers, Distributors, Medical institutions, Service providers, Researchers & Start-ups), to list products and services and expand businesses locally and internationally at ease.

• Access latest regulatory news/events, or post your own needs. 

join atto

JOIN ATTOPOLIS

A Multi-functional B2B Platform for MedTech Industry

Lead, Connect and Globalize your company

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For All Stakeholders

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Features

AttoNews

News & Join Events

AttoForum

Post your needs or help others

AttoTrade

Create/Find eStorefront

& Product in marketplace

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AttoService

Create/Find eStorefront & Service providers

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Showcase

Showcase Partners

Addons

Advertisement & promotion

select your plans

Membership plans

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ARQon Group 10th years Anniversary 2024

- 5% discount on Product Approval Registration service for ATTOPOLIS member.

- Free ATTOPOLIS signup. Go Digital today!

We help to Lead, Connect and Globalise your company.

- 6 months free hotdesk office + 1 month admin support for Company Incorporation service.

- 70% to 90% funding for 1- 4 days IMDS training and free networking event yearly.

- Free useful guide on regulatory, commercial, trademark in ATTOPOLIS platform.

Premium Addon: New Market Matching program 

- Market strategy, Distributor matching and Management

- Massive Product on boarding (free)

- Product Showcase (free)

JOIN US TODAY !

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Regular Events

ARQon GoStrategy

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  • Supports Startups with Regulatory and Market Access.

  • Quarterly run in Singapore, held onsite.

  • Community partner: NHIC, SMF MTIG, NUS GRIP.

  • Sharing for 30 minutes & 1:1 consultation.

Attopolis GoGlobal

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  • Support All companies with Market Penetration/Overseas Expansion.

  • Quarterly run via Webinar, held online.

  • Community partner: SMF SME, SMF MTIG, NUS GRIP.

  • Event target by Region: ASEAN, Europe, North Asia (JP, KR), Latin America, Middle East (India).

Networking Reception at MEDICA

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  • Support all companies with business opportunities through networking.

  • Partner with VibaZone Startup Incubator.

  • Participate as Panel Speakers.

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Our Clients

Regulatory

• Product registration & Product License Holder for implant, IVD, AI & therapeutics, (eg drug, supplement)

• Monthly regulatory support for regional registration

• Wireless, radiation & mandatory packaging reporting to Authority

• Post-market reporting to Authority on adverse event & recall

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B2B Marketplace,

Forum, News

• Product listing by manufacturer

• Post forum used by startups to request for distributor search

• Service providers (eg contract manufacturer & translation) to list their service

• Distributors to look for innovation product

• Organizations to post event, HSA focus group & public consultation, funding to share to medtech professionals.

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Commercial

• Connect to Clinician, advise on new indications & training. Connect 3PL or Tapping MedtechBOSS Importer/Wholesaler/Product owner GDPMD/ISO for supply to hospitals

• Country Trade mission business matching for EU companies to SG potential partners (1-5 per company)

• Find & Set up Importer, Distributor, Rep License with MOH, advise staff hiring & space compliance requirements (eg Indonesia)

• Provide clinical funding, regulatory & commercial support (eg tech licensee, investor to the start-up for working with all 6 clusters of SG hospitals Innovation centre)

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