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  • ARAZY GROUP ANNOUNCES PARTNERSHIP WITH TOXIKON CORPORATION

    Posted on Apr 24, 2013
    Vancouver, BC (April 24, 2013) - Leading regulatory consultancy Arazy Group and Toxikon, one of the world's premier accredited research and testing facilities, announced today the formation of a partnership. The cooperation between the two companies will begin as Arazy Group introduces Toxikon's services to other global markets, starting with Israel. Continue reading
  • COUNTRY AT A GLANCE: BAHRAIN

    Posted on Apr 11, 2013
    The Kingdom of Bahrain is located in the Persian Gulf and consists of 33 islands, which form an archipelago and house just under one and half million people. Bahrain has been rated by the World Bank as having a high-income economy and has been ranked as the fastest growing economy in the Arab world. In 2005, the US-Bahrain Free Trade Agreement was signed, making Bahrain the first state in the Persian Gulf... Continue reading
  • CASE STUDY: FINDING THE GOLDEN MEAN FOR CLASS III MEDICAL DEVICE REGISTRATION WITH THE USA FDA

    Posted on Apr 11, 2013
    On October 1st, 2012, the USA FDA introduced MDUFA III (Medical Device User Fee Amendments), which implemented new regulations for the registration on medical devices. MDUFA III required that most Class III devices be either reclassified as Class II or require a PMA (Pre-Market Approval), which requires a clinical study that may cost upwards of USD $250 000, and can take more than a year to complete. AMECO Medical Industries approached Arazy Group to obtain approval for their new device, the Amecath dual lumen... Continue reading
  • ARAZY GROUP RECOGNIZED AS TOP INNOVATOR THROUGH SELECTION FOR THE CANADIAN TECHNOLOGY ACCELERATOR PROGRAM

    Posted on Apr 03, 2013
    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. Continue reading
  • 5 QUESTIONS & ANSWERS: RECENT REQUIREMENTS FOR MEDICAL DEVICES IN THE USA

    Posted on Mar 23, 2013
    An interview with Priya Bhutani, Regulatory Specialist with Arazy Group in the USA on recent requirements for medical device manufacturers in the United States of America. On October 1st, 2012, all medical device manufacturers must report all proprietary names and combination products (device/biological product/drug) to the FDA at time of listing or during the annual update. All proprietary names currently being used to market in the US must be... Continue reading
  • COUNTRY AT A GLANCE: RUSSIA

    Posted on Mar 21, 2013
    The Federation of Russia, spanning nine time zones and sharing borders with 16 countries, is one of the most resource-rich regions in the world. Ranked as the tenth highest economy according to GDP and sixth largest according to PPP, it is considered one of the fastest growing economies. Although medical device spending per capita remains low in comparison to the European or US markets, the Russian medical device market is among the top 20 in the world. However, health indicators in Russia remain... Continue reading
  • ARE CERTIFICATES OF FREE SALE BEING HELD CAPTIVE?

    Posted on Mar 09, 2013
    A Certificate of Free Sale (CFS) is among the most common and important documents required for submission during the medical device registration process. The CFS proves that your device has been cleared for sale in the country of origin or another market, providing the necessary guarantee to foreign regulators that the device in question has a history of approval and sale. Originally, the CFS document from the country of origin was required for submission. For example, an Indian manufacturer would have a CFS from the government of India. However, in recent times, many countries require a CFS from the European Union or United States in an attempt to ensure that the approval originates from a region with sufficiently high regulatory standards. Since many devices are already required to carry a CE Mark, this did not create a significant obstacle toward obtaining sales and marketing clearance... Continue reading
  • COUNTRY AT A GLANCE: KAZAKHSTAN

    Posted on Mar 07, 2013
    The Republic of Kazakhstan is one of the world's largest countries geographically with a population of over 16 million people. Government spending in the health care sector has increased steadily since 2005, though regulations are undergoing changes as the Ministry of Health aims to improve the quality of health care... Continue reading
  • COUNTRY AT A GLANCE: TURKEY

    Posted on Feb 21, 2013
    Due to its unique geographic location, Turkey is considered neither wholly European nor Middle Eastern, but an intersection of regional politics. Classified as an industrialized, emerging market economy, The prospects for the medical device market in Turkey remain positive, with a USD $1.3 billion medical device industry, as there are strong import growth trends... Continue reading
  • 5 QUESTIONS & ANSWERS: ADDITIONAL REGULATIONS IN THE EU

    Posted on Feb 21, 2013
    An interview with Miki Melech, Regulatory Expert with Arazy Group, on additional registration requirements in the European Union for medical devices that already carry a CE Mark. Currently, France, Italy, Portugal, Poland, Germany, and Spain have additional requirements for the sale of medical devices in their country... Continue reading
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