Since the CE marking of Calmark's first test is expected to be completed up to 6 months earlier than expected, the work with registrating the products also start in countries outside Europe. In order to market and sell medical technology products, regulatory approval is required in the countries where the product is to be used. Within Europe and some other countries, the CE marking applies, even though registration is done only one EU or ESS country. Regulatory clearing is provided throughout the whole area.
Outside Europe, the registration of the products is more complicated, and this work is now initiated by Emergo starting in Asia where registration is required for each country in which the product is to be sold. However, the documentation to be delivered to the authorities in each country is roughly the same and each registration process takes 4-9 months. Most countries require that the product is approved in the home country before registration can commence, which is why the advance CE marking for bilirubin is important.
Emergo is a global consulting company with local representatives in regions that are strategically important for Calmark, such as Southeast Asia. With the local presence and knowledge, they can help with registrations in each country. Emergo have long experience of medical technology products and diagnostic equipment.
“When we are now approaching the launch phase, it is important for us to also early prepare the important regulatory part of the work and here we can gain a lot of time working in parallel with the registrations. Emergo is a major global player who can contribute with resources and knowledge in this area. We look forward to begin selling the products outside Europe as well,” says Anna Söderlund, CEO of Calmark.