Articles

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  • COUNTRY AT A GLANCE: COLOMBIA

    Posted on Jul 31, 2013
    From the heights of the Andes to the rainforest of the Amazon and the coasts of the Pacific Ocean and Caribbean Sea, The Republic of Colombia is one of the largest countries in South America. With 48 million people, its economy is ranked the third largest on the continent and the 28th highest GDP in the world.

    Sweeping health care reform in the 1990s that pledged universal health coverage to Colombians are still underway, with approximately 80% of Colombians... Continue reading
  • 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
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  • Jul 17 2017
    NETHERLANDS TO USE FDA-STYLE UDI SYSTEM FOR MEDICAL DEVICES

    A US-style unique device identification (UDI) coding system for medical devices will be introduced in the Netherlands next year....

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  • Jul 10 2017
    FDA FINALIZES LIST OF CLASS II DEVICES EXEMPT FROM PREMARKET NOTIFICATION

    The US Food and Drug Administration (FDA) has announced a list of 1,003 class II device types that it believes are sufficiently well understood and do not present risks that require premarket notification review to provide a reasonable assurance of safety...

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  • Jun 27 2017
    2017 RAPS REGULATORY CONVERGENCE: BOOTH 300/SEPTEMBER 12 LECTURE, 1.15PM

    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 & Techniques for Faster Market Access’ sess...

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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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