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EUROPE

EU

 

EU

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Market Information

EU's healthcare expenditure has increased by 24.1% from 2012 to 2020

Market Trend: In EU, there has been a steady increase in the total expenditure of healthcare as technology advances and more investment is made into the quality of healthcare provided. 

 

EU’s medical equipment market is projected to reach US$143.20 billion in 2024.

Market Info

Medical Device Regulation

Regulation
Classification, Fees, Timeline
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Classification
Product Registration Routes

Class I, IIa, IIb, III, AIMDs 

All Medical Devices needs to be affixed with the Conformité Européenne (CE) mark in order to be marketed. The new rules and regulations are applied since 26 May 2021. All manufacturers need to comply with the regulations before placing the medical devices on the market. 

Registration
Useful Information

Validity of License: 5 years 

 

License transfer: Change of Registration application needed.

 

Importer and Distributor: Local License Holder, on behalf of the product owner, is responsible to appoint Importers and Distributors.

Useful Info

Contact Us

Main Tel:
+65 69090395

Our Company

About ARQon

Our team

Highlights

Address:
221 Henderson Road #02-08,
Henderson Building,
Singapore 159557

Services

Market Readiness
Assistance

ARQon Registration

Attopolis B2B platform

IMDS Training

Global Presence

America

ASEAN

Asia

Middle East

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