From Yahoo MB techxen • 12 hours ago
Agree - Russia has 143,000,000 people and presents a potentially lucrative market for the company. The addressable market is bigger than France, Poland, Sweden, Denmark, Norway and Finland combined (which is Fresenius territory). However my understanding from what I have read is that registration is challenging. Unlike most countries, Russia still relies on in-country product testing to grant approval for medical devices, and this testing must be completed regardless of whether the device already has US 510(k) clearance or European CE marking. The Russian regulatory environment remained in a state of flux the last 4 years and there have been even more changes and as of today even some areas of the regulatory process remain undefined.
On the positive side of things however is that as a consequence of enforcing changes in the registration rules around the middle of 2014, and having had some years of experience with the new regulatory system, the common trend for 2015 was that medical device registration processes remained challenging, but became quicker and more predictable compared to previous years. According to statistics announced in December by the Roszdravnadzor (Russian medical device regulator), the average time of registration for a medical device in 2015, including clinical evaluation or clinical trials, was 8-9 months for both Russian and foreign manufacturers in 2015.
I think the company probably submitted the registration at a time when the rules were still in flux, thus the lengthy approval time. The latest official status from the company I could find was from the prospectus filed on 11/05/2015: "CytoSorb and its distribution partner in Russia have submitted all requested documentation for registration, and await a response from the Russian authorities."
