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.


 

  • REGULATORY UPDATE: 3SHAPE

    Nov 10, 2014
    JANUARY 2013, TURKEY: 3Shape’s intra oral scanners have been approved for sale in Turkey. Register your devices with LICENSALE.COM™ -- request a free quote today.
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  • REGULATORY UPDATE: OPHTHALMIC DEVICES

    Nov 10, 2014
    DECEMBER 2012, SAUDI ARABIA: Ophthalmic Devices successfully registers with the SFDA, following registration of their ophthalmic medical devices in South Africa, Thailand, and others.
    Full story
  • ARAZY GROUP LAUNCHES LICENSALE.COM™

    Nov 10, 2014
    Vancouver, BC - (Oct 25, 2012) - Leading regulatory affairs firm Arazy Group announced today the launching of LICENSALE.COM™, a novel cloud-based online regulatory management system which will revolutionize international compliances and licensing for both medical device manufacturers as well as national regulatory bodies. The system will provide a much needed integrated platform for simultaneous registration in multiple markets in a cost and time efficient manner. The firm is presenting its new platform this November at Medica 2012 in Dusseldorf, Germany.
    Full story
  • POLAND | ADDITIONAL NOTIFICATION FOR CE MARKED MEDICAL DEVICES AND IVDs

    Nov 10, 2014
    This is a response to the new EUDAMED Requirement – the European Databank of Medical Devices, that has commenced in May 2011. Currently, a Medical Device is introduced to the databank under the country of the authorized representative, even if they are located in another country. The Polish MOH wants to keep track of the products that are marketed in Poland.
    Full story
latest news
  • Apr 24 2017
    70+ CLASS I DEVICES NOW EXEMPT FROM 510(K) REQUIREMENTS

    The US Food and Drug Administration (FDA) has identified a list of over 70 class I devices that are now exempt from premarket notification requirements....

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  • Apr 19 2017
    REGULATORY UPDATE: ETGAR MEDICAL INSTRUMENTS

    USA: Etgar Medical Instruments' Dental Implants System was approved for sale with LICENSALE.COM®. ...

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  • Apr 19 2017
    RUSSIAN REGULATORS ISSUE REQUIREMENTS FOR IVD & MEDICAL DEVICE TECHNICAL FILE SUBMISSIONS

    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. ...

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  • Apr 6 2017
    REMINDER: ARAZY GROUP CAN HELP REGISTER MEDICAL DEVICES IN BRAZIL IN JUST 7-9 MONTHS

    As a member of ABIMED (the Brazilian Association of Industry of High Technology Medical and Hospital Equipments, Products and Suppliers), Arazy Group can help medical device manufacturers register their products in Brazil within seven to nine months. ...

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  • Apr 4 2017
    ARAZY GROUP OFFERS QMS UPGRADE TO ISO 13485:2016 STANDARD

    In line with its commitment to making safe and effective IVD and medical devices available worldwide, regulatory affairs firm Arazy Group Consultants Inc. is assisting MedTech manufacturers in meeting the deadline to upgrade their quality management syste...

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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

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