ServiceUpdated on 21 February 2025
International market access (from EU to US and China)
About
Beside typical CE certification we support regulatory affairs in following country:
- China
Local testing and unique Chinese requirement
Visit our Chinese regulatory dictionary Non stop regulatory intelligence of medical device
*Besides it, we can accompany all activities from China and to China in Medtech, e.g.
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Prototype for Manufacturing in China
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Chinese investition in EU
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Academic cooperation
- US and Canada
Calculable with clear regulation
- Japan
Communication is a barrier
- Korea
Dealing with testing is the key
English documents are sufficient plus traditional Chinese of labelling
MDSAP certification can leverage review time
- Australia/UK/Swiss
Unexpected fast if in EU is approved.
Anvisa is basic, Inmetro getting easier, Anatal complex
- Mexico
Authority starts to accelerarte the review again.
Read article: International market of medical device for Startups,SME
Other services
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International quality management system application (as QSD in Taiwan, QMS in Japan, GMP in Brasil)
Type
- Development
- Consulting
- Manufacturing
Applies to
- Biotech and Lifescience
- Medtech
Organisation
Similar opportunities
Service
- Medtech
- Consulting
Liang (Antonio) Dr. Li
Founder at Medkaizhen
Ulm, Germany
Partnership
E-Learning and academic cooperation
Liang (Antonio) Dr. Li
Founder at Medkaizhen
Ulm, Germany
Product
Application-Oriented Anatomical Models
Bernhard Nussbaumer
Shareholder & CBDO at ACMIT Gmbh
Wiener Neustadt, Austria