NEWS ROOM

See the latest news from our company below or use the search feature. For more information, contact our head office or the Marketing Communications Manager directly at marcom@arazygroup.com.


 

RUSSIAN REGULATORS ISSUE REQUIREMENTS FOR IVD & MEDICAL DEVICE TECHNICAL FILE SUBMISSIONS

by Arazy Group | Apr 20, 2017
The Russian Ministry of Health has introduced a new regulation that clarifies the official requirements for in vitro diagnostic (IVD) & medical device technical file submissions.

Issued in Russian, the new regulation known as Order #11N (link in Russian) sets out existing but unofficial requirements from Russia’s medical device regulator, Roszdravnadzor.

Up until March 24, 2017, when the new requirements became effective, information on the structure of technical documentation had been available only as recommendations and voluntary standards. Technical files in registration dossiers for medical devices and IVD products must now contain specific mandatory clauses/chapters.  

Contact us today to discuss the new requirements and to discover how regulatory intelligence and registration management system LICENSALE.COM® assists MedTech firms in gaining access to 100+ markets faster and more cost-effectively than ever before.

 

 

Back to Press Room

latest news
  • Oct 17 2017
    REGULATORY UPDATE - XERIDIEM

    Brazil: Xeridiem's Entuit Family was approved for sale with LICENSALE.COM®. ...

    Read More
  • Oct 16 2017
    REGULATORY UPDATE - TECRES MEDICAL

    Malaysia: Tecres Medical's Rally AB Bone Cements were approved for sale with LICENSALE.COM®. ...

    Read More
  • Oct 16 2017
    REGULATORY UPDATE - TECRES

    Singapore: Tecres Medical's Rally Bone Cements were approved for sale with LICENSALE.COM®. ...

    Read More
  • Oct 3 2017
    REGULATORY UPDATE - XERIDIEM

    Taiwan: Xeridiem's Entuit Thrive was approved for sale with LICENSALE.COM®. ...

    Read More
  • Sep 29 2017
    Kickstart a Medtech Start-Up Initiative

    It is challenging for Medtech Start-up companies to achieve success, mainly due to the heavily regulated nature of medical devices. ...

    Read More

VANCOUVER OFFICE

  • Phone +1 604.681.6888
  • Fax +1 604.681.6822
  • info@arazygroup.com
  •  
  • #350-1333 Johnston Street
  • Pier 32, Granville Island
  • Vancouver, British Columbia
  • Canada V6H 3R9

BACK TO TOP