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 … Read more

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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 … Read more

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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 … Read more

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Sunchip 2

New in HIPEC. Sunchip – New Generation!

UDI compliance deadline

85% of manufacturers are not prepared for upcoming UDI compliance deadline September 24th deadline requires labels and packages of Class II medical devices such as condoms, wheelchairs and pregnancy tests to bear UDI barcodes. Data on Class II devices also must be submitted to the FDA’s Global Unique Device Identification Database. The database will serve … Read more

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CMS and FDA advocate for device identifiers on claims forms

The heads of the CMS (Centers for Medicare & Medicaid Services) and the Food and Drug Administration want universal health insurance claims forms to include unique device identifiers. The UDI would improve post-market surveillance and provide for better value-based reimbursement based on device performance, they say. CMS Administrator Andy Slavitt and FDA Commissioner Dr. Robert … Read more

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FIME 2016

The FIME Medical Trade Fair & Congress is the largest international medical event held in the United States annually.

China’s 13th Five-Year Plan

China adopted its 13th Five-Year Plan, which outlines China’s goals, principles and targets for its development through to 2020.