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ARQon
MedtechBOSS
Attopolis
IMDS
Registration @ ARQon

We provide Regulatory Support for Local & Global

Product Approvals and Compliance to local requirement on QMS with a Vision to assist companies to launch products faster in the market.

  • Medical Device

  • Drugs

  • Health Safety

  • Sustainability

  • License Holding

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License Holding

We can hold your license for you.

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Product Registration

Allow you to supply or trade your medical device in targeted countries.

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Extra RA/QA Support

Comply with goverment regulation and higher quality products

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Global Approval

It doesn't matter where you're from.

ARQon Service

Other services @ ARQon

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MedtechBOSS

- Business One Stop Service -

  • Medical Device File/Technical File/Documentation CE, US

  • Quality Management System - ISO13485, USQSR, MDSAP, etc.

  • Commercial matching business - destributor search, etc.

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  • B2B International Medical Digital Platform that connects your business and showcase the variety of products and services globally

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  • Product Lifecycle Training for Medtech Professionals

  • Local & International Speakers

  • Co founded by ARQon and ARPA

Gazette News

HIGHLIGHTS

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BLOGS

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LIBRARIES

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ARQ®-Class for Medical Device

A tool to classify a medical device

Complimentary for Client/Education/Authority
Existing Member Log In

Classification for Medical Device Medical device are generally classified into 4 classes.

  • ASEAN MDD: Class A, B, C and D

  • EU MDD: Class I, IIa, IIb and III

Bulgaria

Germany

NZ source: Medsafe

New Zealand Medsafe Authority,Medical Device Registration and Regulatory Consultant

Japan X2

Malaysia X2

Malaysia MDA Medical device registration
Malaysia MDA Medical device registration

Singapore

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