Articles

Browse our regulatory articles below or search through our archive.

 


 

  • COUNTRY AT A GLANCE: TAJIKISTAN

    Posted on Mar 26, 2015
    Located in Central Asia, the Republic of Tajikistan is a mountainous, landlocked country, bordered by Afghanistan, Uzbekistan, Kyrgyzstan and China. A presidential republic comprising four provinces, it spans over 140 000 km2 and is home to more than 8 million people. The population of Tajikistan is young and growing rapidly, with more than half of the country below 25 years old. Such demographic shifts are dictating the direction of the government, which is focused on reforming the critical agriculture sector, reducing poverty, creating jobs, and improving public services such as healthcare. Continue reading
  • COUNTRY AT A GLANCE: FRANCE

    Posted on Mar 12, 2015
    France has one of the top five largest medical device markets in the world, according to a report from Espicom, and the market is estimated to be worth USD $14.4 billion in 2013. The French government is attempting to curtail spending on medical devices in line with Europe’s trend towards austerity in the wake of the global financial crisis; however... Continue reading
  • COUNTRY AT A GLANCE: AUSTRALIA

    Posted on Feb 12, 2015
    The Commonwealth of Australia is one of the largest countries in the world, comprising one large landmass and several small islands located in the Pacific and Indian oceans. Australians spent approximately USD $133.8 billion on healthcare in 2015 (9.1% of GDP), most of which was spent by the federal and state/territory governments (according to the Medical Technology Association of Australia’s report). Per capita spending, set at USD $5663 in 2014, has doubled in the last ten years. The local medical device manufacturing market is significant, with over 500... Continue reading
  • LICENSALE.COM™ RECOGNIZED AS GAME-CHANGING INNOVATION BY FROST & SULLIVAN

    Posted on Feb 12, 2015
    Arazy Group is proud to announce two prestigious Frost & Sullivan awards earned by our company this week. Read more for an interview with Jeff Moad, Research Director & Executive Editor at Frost & Sullivan, on why Arazy Group was recognized, including in the most prestigious category of the night... Continue reading
  • COUNTRY AT A GLANCE: MEXICO

    Posted on Jan 29, 2015
    With a population of over 122 million, Mexico is the second most populous country in Latin America and the eleventh most populous in the world. The country is a federal republic composed of thirty one states and spanning nearly two million square kilometres. Economically, Mexico is a major player on the world stage; in 2013, their GDP was estimated at $1260 billion USD, or 2.0% of the world economy, with an annual growth rate of... Continue reading
  • CASE STUDY: HOW ONE MEDTECH COMPANY IS GAINING ACCESS TO SIX NEW MARKETS WITH ONE UNIVERSAL SOLUTION

    Posted on Dec 11, 2014
    Luminex Corporation is a biotechnology company based in Austin, Texas, USA with offices in Madison, WI, , Canada, China, Japan, and the Netherlands. Luminex develops, manufactures, and markets products like the Multi-Analyte Profiling (xMAP) technology, which allows simultaneous analysis of up to 500 bioassays from a small sample volume and is being used within various segments of the life sciences industry, including the fields of drug discovery and development, clinical diagnostics, genetic analysis, bio-defense, food safety, and biomedical research.
    With USA FDA clearance, CE Mark, Health Canada approval, PMDA notification, and CFDA approval, Luminex was looking to expand their business into new markets. Their sales team developed a strategic plan for a set of target countries. The regulatory department was tasked with evaluating partners for registration of their high-class in vitro diagnostic devices... Continue reading
  • COUNTRY AT A GLANCE: ETHIOPIA

    Posted on Oct 30, 2014
    The Federal Democratic Republic of Ethiopia, situated in the Horn of Africa between Eritrea, Djibouti, Somalia, Sudan, South Sudan, and Kenya, has the second highest population in Sub-Saharan Africa estimated at nearly 88.8 million people in 2014. Its ecosystem is diverse, ranging from mountains to jungle to hot lowlands, to the banks of the Nile and many rivers. Ethiopia is a founding member of the United Nations and is actively involved in the African Union.

    Ethiopia’s economy has grown in recent years after decades of low rankings in the global economy; it now has the largest economy in East and Central Africa. Government reforms across a broad range of institutions and structures have paid off with significant reductions in poverty rates, improved health and education indicators, increased agricultural infrastructure and production, and more. In 2013, Ethiopia’s GDP continued to grow at more than twice the regional average rate (10.4%)... Continue reading
  • 510(k) PERFORMANCE: 11 CLEARED DEVICES IN 16 MONTHS WITH LICENSALE.COM™

    Posted on Sep 30, 2014
    The summer of 2014 marked an important milestone for LICENSALE.COM™, Arazy Group’s product registration system. Hanin Medical’s SAAD patient monitor, the first Saudi designed and manufactured device of its kind to be cleared for sale in the EU and USA, received its 510(k) clearance in August 2014. Although this was an achievement on its own, it was the latest in an unbroken period of 11 successful 510(k) clearances submitted between 2013 and 2014.

    Read more for the stories of six of the eleven MedTech manufacturers who discovered how LICENSALE.COM™ could get their products to market faster and at lower cost through three key strategies... Continue reading
  • COUNTRY AT A GLANCE: CHILE

    Posted on Sep 18, 2014
    The Republic of Chile is situated along the Andes mountains on the Pacific Coast, bordering Peru, Bolivia, and Argentina. With a population of over 17.6 million people, its geography ranges from mineral-rich desert in the north, metropolitan cities in the centre, and forests, valleys, volcanoes, islands, and lakes in the south. One of Latin America’s leading nations in economic, social, political, and environmental measures, Chile was the first South American country to join the OECD.

    In 2012, the WHO reported total health expenditure at 7.2% of the GDP or USD $1606 per capita, ranking Chile as one of South America's top spenders on healthcare and the highest per capita spender in Latin America. According to a 2009 report from the government of Switzerland, 43% of medical devices in Chile are... Continue reading
  • 101 COUNTRIES AND COUNTING: MEDTECH COMPANIES GAIN ACCESS TO GLOBAL MARKETS WITH LICENSALE.COM™

    Posted on Sep 18, 2014
    VANCOUVER, CANADA (SEPTEMBER 2, 2014): In a testament to its rapid adoption and unprecedented success since its official launch 18 months ago, online MedTech registration system LICENSALE.COM™ continues to expand its pre-market approval capabilities into new markets around the world, now totalling 101 countries.

    Tried and tested through complex registrations by multinational MedTech companies like Elekta, Physio Control, Toshiba, SPD, Luminex, FujiFilm Sonosite, P&G, T-DOC/Laborie, C Bard, and many smaller manufacturers and start-up companies, LICENSALE.COM™ is successfully processing thousands of applications for devices of all classes from Latin America to Central Asia, the Middle East, Sub-Saharan Africa, and more. 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. ...

    Read More
  • 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

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