The 2nd International Congress on Clinical Trials for Medical Devices (CTMD2016)

CTMD2016 will focus on the latest developments and upcoming regulations on clinical trials for medical devices in the EU and the US as well as in Brazil, Russia, India and China (BRIC countries) and the Oceania region.

LOK representatives from Israel, Brazil, India, China and Europe will be attending at CTMD2016, and we are happy to announce you that you will have a chance to meet them and ask your questions!

If you would like to schedule a meeting with one of our representatives, please contact us 

For more details regarding the upcoming event, please visit the congress website: 

Russia: Deadlines for the Procedure of Administrative Replacement of Registration Certificates

There are less than five months left until the deadline set by the Russian government in 2012 for the procedure of administrative replacement of “old” registration certificates for medical devices that were issued before 2013. According to Roszdravnadzor (the Russian medical device regulator), less than 9.2 thousand files for replacement have been submitted to authorities by medical device manufacturers since 2013 (out of the 37.5 thousand registration certificates which require replacement). Some experts say that this situation can lead to a problem where a significant number of medical devices may lose their approval in the Russian market from January 2017.

In the same time, the new Eurasian medical device regulation model requires medical device manufacturers to re-register their products by the end of 2021, according to the new Eurasian registration procedure.

Considering this, IMEDA (International Medical Device Manufacturers Association) sent a petition to the Ministry of Health of Russia with the suggestion to extend deadlines for the replacement of “old” registration certificates until the end of 2021.

Later in August, Roszdravnadzor issued a news release pointing out that the procedure for the replacement of registration certificates takes 30 days, and that today “medical device manufacturers have enough time to get new registration certificates.” determining that the statements about potential problems on the medical device market in 2017 stemming from bureaucratic reasons were “baseless.”


SoClean at Medica 2016

31 August 2016 – SoClean Inc. (Massachusetts, USA), a medical device company focused on improving the health and quality of life for those who suffer from obstructive sleep apnea (OSA) and other sleep disorders, will be present at Medica 2016 Hall 17 stand ???

If you would like to meet with SoClean management at or around this event, please contact the event organizers at 

About SoClean

The world’s first automated CPAP cleaner and sanitizing machine introducing a faster, easier, more effective way to clean CPAP equipment. The SoClean CPAP cleaning unit kills 99.9% of CPAP germs and bacteria in your mask, hose and reservoir with no disassembly, no water, and no chemicals. It’s the safer, healthier way to breathe cleaner and have a better CPAP experience.

Further information about LOK Corporation can be found at