Benjamin Arazy

Benjamin Arazy
President & CEO
Arazy Group Consultants Inc.


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latest news
  • Jun 27 2017
    2017 RAPS: DON’T MISS INVALUABLE INSIGHTS ON REGULATORY STRATEGIES FOR MARKET ACCESS

    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 for Market Access’ session at this year’s R...

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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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  • Jun 11 2017
    SOUTH AFRICA: NEW REGULATORY AUTHORITY OVERSEES MEDICAL DEVICES

    Medical devices in South Africa are now regulated by the newly established South African Health Products Regulatory Authority (SAHPRA), which has replaced the Medicines Control Council (MCC)....

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  • Jun 7 2017
    FDA EXTENDS UDI COMPLIANCE DEADLINES FOR LOW-RISK MEDICAL DEVICES

    The US Food and Drug Administration (FDA) has extended the compliance deadlines for the unique device identification (UDI) system requirements for certain class I and unclassified medical devices from September 24, 2018 to September 24, 2020....

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  • Jun 5 2017
    AUSTRALIA: CONSULTATION ON COMPARABLE OVERSEAS REGULATORS FOR MEDICAL DEVICES OPENS

    Australia’s Therapeutic Goods Administration (TGA) is seeking comments from the MedTech industry and regulators on the use of marketing approval by comparable overseas regulators for medical devices in overseas markets to support the inclusion of them in ...

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VANCOUVER OFFICE

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

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