In order to market medical devices in China, manufacturers shall appoint a Legal Agent established in China who plays an important role both in pre-market and post-market phase. In particular, the Legal Agent acts as an interface with the competent Authority, he supports the foreign manufacturer to correctly classify the device for the registration procedure …

Marketing in China: what is the Legal Agent responsible for? Read More »

How do I find the information I need to sell my devices?Finding information is the trickiest part. You can collect data from different sources of information, even if you always need to verify their reliability and update status. Specialized magazines, portals and websites, publications, seminars and conferences are only some of the possible information sources.

On 15th December 2021, the new Commission Implementing Regulation (EU) 2021 / 2226 on electronic instructions for use of Medical Devices (eIFU) has been published on the Official Journal of the European Union. This Regulation repeals the previous Commission Regulation 207/2012 adapting to MDR (EU) 2017/745 requirements. However, the Commission Regulation (EU) 207/2012 still applies …

EU: new Regulations Read More »