ServiceUpdated on 21 February 2025

International market access (from EU to US and China)

Liang (Antonio) Dr. Li

Founder at Medkaizhen

Ulm, Germany

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.

  1. Prototype for Manufacturing in China

  2. Chinese investition in EU

  3. 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

Type

  • Development
  • Consulting
  • Manufacturing

Applies to

  • Biotech and Lifescience
  • Medtech

Organisation

Medkaizhen

Professional Service Provider

Ulm, Germany

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