Articles

Browse our regulatory articles below or search through our archive.

 


 

  • DO THIS BEFORE ATTENDING 2017’S CHINA INTERNATIONAL MEDICAL EQUIPMENT FAIR

    Posted on Feb 06, 2017
    If you’re attending this year’s China International Medical Equipment Fair (CMEF), you could benefit greatly from applying for premarket approval beforehand. Continue reading
  • THE GCC HEALTHCARE MARKET SERIES: OMAN

    Posted on Jan 31, 2017
    Find out about Oman’s healthcare sector and medical devices market. Continue reading
  • ARAB HEALTH: THINGS YOU SHOULD KNOW BEFORE MEETING LOCAL DISTRIBUTORS

    Posted on Jan 20, 2017
    Going to Arab Health? Introducing your medical or in vitro diagnostic (IVD) device in the GCC member states or other countries in the Middle East? Read on to get up to speed with product registration procedures and license information before you meet with local distributors. Continue reading
  • THE GCC HEALTHCARE MARKET SERIES: BAHRAIN

    Posted on Dec 14, 2016
    This article, the third in The GCC Healthcare Market Series, explores Bahrain’s healthcare system and medical devices market. Continue reading
  • THE GCC HEALTHCARE MARKET SERIES: KUWAIT

    Posted on Sep 01, 2016
    This article, the second in The GCC Healthcare Market Series, explores Kuwait’s healthcare system and medical devices market. Continue reading
  • THE GCC HEALTHCARE MARKET SERIES: SAUDI ARABIA

    Posted on Jun 29, 2016
    This article is the first of a series on the healthcare and medical device markets in The GCC countries. Continue reading
  • CLIENT AT A GLANCE: PATIENT POCKET

    Posted on Jun 29, 2016
    When it comes to safety devices, the LaserDock® is truly one of a kind. It is the only laser fiber safety product on the market. Designed for single use, this ingenious creation of Patient Pocket LLC received Food and Drug Administration (FDA) clearance (K152636), through cloud-based global product registration service LICENSALE®. Continue reading
  • ONE BIG IMPROVEMENT TO MEDTECH REGISTRATION IN RUSSIA

    Posted on Sep 16, 2015
    The Russian regulatory system is notoriously difficult, lengthy, and expensive. This is in large part due to the fact that Russian authorities under Roszdravnadzor require local testing in Russian hospitals and testing facilities in addition to foreign clinical evaluation and EMC and IEC tests reports.

    As of July 17, 2015, Class I devices in Russia have been given a simplified, shorter regulatory pathway for regulatory authorities and manufacturers alike. While previously most Class I devices, sterile devices in particular, had to go through costly and time-consuming local clinical testing even if they have valid documentation of testing conducted elsewhere, this requirement has now... Continue reading
  • 5 BIG QUESTIONS (& ANSWERS): SAUDI ARABIA’S NEW OFFICIAL REGULATORY SYSTEM

    Posted on Jul 22, 2015
    The SFDA (Saudi Food and Drug Administration) did not regulate medical and IVD devices prior to the introduction of the interim system in 2012. New requirements have been phased in since that time and all medical and IVD (in vitro diagnostic) devices will need Medical Device Marketing Authorization (MDMA) from the SFDA by the end of 2015. The last devices to be phased in are low-risk medical devices (by December), while an MDMA is mandatory for low-risk IVD devices as of... Continue reading
  • COUNTRY AT A GLANCE: ECUADOR

    Posted on Jul 09, 2015
    Ecuador’s regulatory framework has undergone significant changes over the past five years across several sectors. For medical devices, this has altered the regulations themselves and the regulatory oversight and enforcement bodies. Some research agencies have reported that the increased regulation, notably regarding price control and importation restrictions, has negatively affected international business opportunities in Ecuador.

    However, success in improving health services has created significant opportunities for medical tourism and other areas, especially as more than half of healthcare market spending remains in the private sector... Continue reading
latest news
  • Nov 23 2017
    REGULATORY UPDATE - XERIDIEM

    Taiwan: Xeridiem's Entuit ENFit Standard was approved for sale with LICENSALE.COM®. ...

    Read More
  • Nov 23 2017
    REGULATORY UPDATE - VAREX IMAGING CORP.

    Italy: Varex Imaging's X-ray Tube and detector were approved for sale with LICENSALE.COM®....

    Read More
  • Nov 14 2017
    REGULATORY UPDATE - PERFLEX

    Canada: Perflex's Class II Denture Materials were approved for sale with LICENSALE.COM®....

    Read More
  • Nov 6 2017
    REGULATORY UPDATE - VAREX IMAGING CORP.

    China: Varex Imaging's Wuxy was approved for sale with LICENSALE.COM®....

    Read More
  • Oct 26 2017
    REGULATORY UPDATE - VAREX IMAGING CORP.

    China: Varex Imaging's X-ray Tube was 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

BACK TO TOP