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.


 

  • ARAZY GROUP OPENS LICENSALE™ HQ IN SAN FRANCISCO

    Nov 07, 2014
    On March 1st, Arazy Group opened our new headquarters for LICENSALE™ in San Francisco, California.
    Full story
  • REGULATORY UPDATE: ULTRASONIX

    Nov 10, 2014
    FEBRUARY 2013, EU: Ultrasonix's SonixGPS™ Needle Sensors, SonixGPS™ Nerve Block Needle Kits, and SonixGPS™ Vascular Access Needle Kits have been approved for the sale in the European Union.
    Full story
  • UPDATE ON MEDICAL DEVICE PRODUCT REGISTRATION TURN-AROUND-TIME FOR SINGAPORE

    Nov 10, 2014
    With the implementation of the Medical Device Regulations since August 2010, HSA has been experiencing a very high volume of product registration applications for all device categories. Despite the Arazy Group ramping up capacity to meet this high volume, the higher volume and complexity of products being submitted for application have resulted in processing times being longer than the current published turn-around-time (TAT).
    Full story
  • MEXICO | THE SECRETARY OF HEALTH, SALOMON CHERTORIVSKI ANNOUNCES EQUIVALENCE AGREEMENT WITH JAPAN FOR MEDICAL DEVICES

    Nov 10, 2014
    The goal is to expand the supply of Japanese leading-edge medical equipment to Mexicans and strengthen the competitiveness of the economy.
    Full story
  • LATEST NEWS FROM US-FDA CENTER FOR DEVICES AND RADIOLOGICAL HEALTH | 10 JULY 2012

    Nov 10, 2014
    Today, President Obama signed the FDA Safety and Innovation Act (FDASIA). This law includes the Medical Device User Fee Amendments of 2012 (MDUFA III) as well as other medical device provisions. MDUFA III will be in effect for five years beginning October 1, 2012. It includes performance goals and user fees paid to the Food and Drug Administration (FDA) by medical device companies when they register and list with the FDA and when they submit an application to market a medical device in the U.S.
    Full story
  • REGULATORY UPDATE: MEDXL

    Nov 10, 2014
    JANUARY 2013, TURKEY: <a href="http://www.medxl.com/">MedXL</a> prefilled syringes have been licensed for sale in Turkey. Register your medical devices online with LICENSALE.COM™.
    Full story
  • REGULATORY UPDATE: 3SHAPE

    Nov 10, 2014
    JANUARY 2013, TURKEY: <a href="http://www.3shape.com/">3Shape</a>’s intra oral scanners have been approved for sale in Turkey. Register your devices with LICENSALE.COM™ -- request a free quote today.
    Full story
  • 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 9 2018
    MDSAP Transition in Canada

    Health Canada is allowing a "grandfather" period in 2019 for applicants who do not have an MDSAP certificate issued by December 31, 2018....

    Read More
  • Apr 9 2018
    REGULATORY UPDATE - ALPHA BIO

    Italy: Alpha Bios' GSTK (Implant Mount CS) was approved for sale with LICENSALE.COM®....

    Read More
  • Mar 26 2018
    REGULATORY UPDATE - DR. KORMAN LABORATORIES

    Peru: Dr. Korman Laboratories' Dermal Fillers were approved for sale with LICENSALE.COM®....

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  • Mar 22 2018
    REGULATORY UPDATE - CLARIUS MOBILE HEALTH

    Ecuador: Clarius Mobile Health's Clarius Ultrasound Scanner was approved for sale with LICENSALE.COM®....

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  • Mar 22 2018
    REGULATORY UPDATE - SPD

    Peru: SPD's CB 9 and CB11 were approved for sale with LICENSALE.COM®....

    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

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