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.


 

MEET MDSAP TRANSITION DEADLINE TO CONTINUE TRADING ON CANADIAN MARKET

by Arazy Group | Mar 21, 2017
In vitro diagnostic (IVD) and medical device manufacturers must transition to the Medical Device Single Audit Program (MDSAP) before January 1, 2019 in order to continue trading on the Canadian market.

Health Canada will end its Medical Devices Conformity Assessment System (CMDCAS) and only accept certificates issued under the MDSAP, an initiative whereby manufacturers are audited once for compliance with the standard and regulatory requirements of one or more of the following countries:  Australia, Brazil, Canada, Japan and the United States. Manufacturers that obtain MDSAP certificates will meet the quality management system requirements of the Medical Devices Regulations.

Licences already obtained using a CMDCAS certificate will be subject to suspension if they are not supported by a valid MDSAP certificate after the deadline. For manufacturers that only sell products in Canada, the regulatory requirements of the other MDSAP participating countries will not be audited.

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

 

 

Back to Press Room

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....

    Read More
  • Apr 19 2017
    REGULATORY UPDATE: ETGAR MEDICAL INSTRUMENTS

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

    Read More
  • 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. ...

    Read More
  • 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. ...

    Read More
  • 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...

    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