Articles

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  • THE ELEKTA CASE STUDY: 76 PRODUCTS, 16 COUNTRIES, 12 MONTHS

    Posted on Jul 31, 2013
    In August 2012, Arazy Group was approached by Elekta, which provides clinical solutions for the entire spectrum of care in oncology, neurosurgery, radiosurgery, and radiotherapy for precision treatment of cancer and brain disorders. Elekta solutions in oncology and neurosurgery are used in 6000 hospitals globally, and every day more than 100 000 patients receive diagnosis, treatment, or follow‐up with the help of the company's solutions... Continue reading
  • COUNTRY AT A GLANCE: TUNISIA

    Posted on Jul 11, 2013
    The Republic of Tunisia is the smallest country in North Africa, with over 10 million residents and one of the highest standards of living in the continent of Africa. With 1300 kilometres of coastline on the southern Mediterranean coastline, Tunisia has strong trade ties with its African neighbours and European countries across the sea. In 2011, 66% of Tunisia’s foreign trade was with Europe.

    Despite the global economic recession, Tunisia has maintained steady growth throughout the past decade. Tunisia has worked toward free trade, export-led growth, and more open economic policies that are favorable to the private sector. Today, Tunisia’s economy is among the most diversified... Continue reading
  • COUNTRY AT A GLANCE: ISRAEL

    Posted on May 30, 2013
    A country of just over 8 million people, Israel is located in the Middle East on the coast of the Mediterranean Sea. It is home to diverse landscapes; from beaches and valleys to mountains and deserts, this small country has become internationally recognized as a powerhouse of innovation and entrepreneurship. Today, its highly developed economy has resulted in the highest standard of living in the Middle East and one of the highest life expectancies in the world... Continue reading
  • 6 ADVANTAGES OF YOUR FDA APPROVAL OUTSIDE THE USA

    Posted on May 30, 2013
    Any medical device that carries USA FDA approval automatically benefits when registering the same device in other international markets. Whereas many companies found little need to look beyond the major economic markets before the 2008 global financial crisis, recently, many companies have turned to emerging markets for growing opportunities in sales and marketing of medical devices. The realized and potential expansion in these markets has resulted in significant gains for MedTech companies of all sizes.

    One of the greatest challenges of diversifying international sales is navigating the variant and sometimes complex regulatory systems, particularly in regions where a manufacturer may not have sufficient... Continue reading
  • COUNTRY AT A GLANCE: MOROCCO

    Posted on May 09, 2013
    Bordering both the Atlantic Ocean and the Mediterranean Sea, the Kingdom of Morocco is an attractive point of investment around the world. Morocco possesses a population of 32 million people and an economy that is projected to continue a trend of growth by 4.2% in 2013. Morocco's main industries are tourism, phosphates, and agriculture.

    New government programs and plans to improve access to and quality of healthcare are increasing access to medical devices for much of the population. Recent growth in the health sector has been supported by... Continue reading
  • COUNTRY AT A GLANCE: THAILAND

    Posted on Apr 24, 2013
    The Kingdom of Thailand, a country with a population of well over 65 million people, acts as a regional hub in Southeast Asia. Along with countries like Malaysia and Indonesia, it is considered a relatively new hot spot for investment and sale of medical devices. The Thai government is working to improve and accelerate R&D for medical devices and has assigned the Board of Investment (BOI) to offer incentives to both Thai and foreign investors... Continue reading
  • 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
latest news
  • May 7 2017
    SOUTH AFRICA: ARAZY GROUP LISTS NON ELECTRO-MEDICAL DEVICES ON BEHALF OF MANUFACTURERS

    Arazy Group Consultants Inc. is listing non electro-medical devices with South Africa’s Competent Authority on behalf of manufacturers before the authority’s August 2017 deadline, as well as acting as an Authorized Representative. ...

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  • 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....

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  • Apr 19 2017
    REGULATORY UPDATE: ETGAR MEDICAL INSTRUMENTS

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

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  • 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. ...

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  • 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. ...

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