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.


 

  • REPORT ON ANVISA B-GMP INSPECTION REGIME

    Nov 10, 2014
    This is to report on the current situation regarding B-GMP (or “BPF”) certification by ANVISA. This regime came into effect on 22 May 2010. After this resolution was published in May 2009 there was widespread concern about ANVISA´s capacity to audit manufacturers all over the world. Now it is obvious that ANVISA does not have the resources to inspect manufacturers within the time frame established by law, which theoretically should more than 90 days after being required, but actually delays well over 6 months take place.
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  • REGULATORY UPDATE: UMF

    Nov 10, 2014
    MARCH 2013, SAUDI ARABIA: UMF's line of treatment tables have been approved for sale.
    Full story
  • REGULATORY UPDATE: EYETECH

    Nov 10, 2014
    MARCH 2013, EU: EyeTech’s Eye movement analysis systems, TM4 and TM4 mini, were approved for sale in European Union. Register your device now with LICENSALE.COM™.
    Full story
  • ARAZY GROUP SELECTED AS TOP INNOVATOR THROUGH SELECTION FOR THE CANADIAN TECHNOLOGY ACCELORATOR PROGRAM

    Nov 10, 2014
    Vancouver, B.C. (March 14 2013) – The Government of Canada announced this week that medical device consultancy Arazy Group is one of eight companies selected to participate in the Canadian Technology Accelerator program, which connects ground-breaking Canadian companies with the Cambridge Innovation Center in Boston, Massachusetts.
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  • 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.
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  • 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.
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  • 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).
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  • 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.
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  • 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.
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  • REGULATORY UPDATE: MEDXL

    Nov 10, 2014
    JANUARY 2013, TURKEY: MedXL prefilled syringes have been licensed for sale in Turkey. Register your medical devices online with LICENSALE.COM™.
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  • 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.
    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.
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  • 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.
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  • 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.
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latest news
  • Jul 17 2017
    REGULATORY UPDATE - XERIDIEM

    UAE: Xeridiems' Entuit Family was approved for sale with LICENSALE.COM®. ...

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  • Jul 17 2017
    NETHERLANDS TO USE FDA-STYLE UDI SYSTEM FOR MEDICAL DEVICES

    A US-style unique device identification (UDI) coding system for medical devices will be introduced in the Netherlands next year....

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  • Jul 10 2017
    FDA FINALIZES LIST OF CLASS II DEVICES EXEMPT FROM PREMARKET NOTIFICATION

    The US Food and Drug Administration (FDA) has announced a list of 1,003 class II device types that it believes are sufficiently well understood and do not present risks that require premarket notification review to provide a reasonable assurance of safety...

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  • Jun 27 2017
    2017 RAPS REGULATORY CONVERGENCE: BOOTH 300/SEPTEMBER 12 LECTURE, 1.15PM

    MedTech regulatory affairs professionals managing the launch of products in new markets and maintaining market approval globally will benefit from the invaluable insights shared during the ‘Regulatory Strategies & Techniques for Faster Market Access’ sess...

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  • Jun 13 2017
    FDA TO REQUIRE NEW VALIDATION DATA FOR LIST OF REUSABLE MEDICAL DEVICES

    The US Food and Drug Administration (FDA) has unveiled a list of reusable medical devices for which it will require validation data regarding cleaning, disinfection and sterilization as well as validated instructions for use in premarket notification subm...

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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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