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  • 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
  • COUNTRY AT A GLANCE: SINGAPORE

    Posted on Feb 06, 2013
    The Republic of Singapore, a densely populated country of five million people, has the third highest per capita income in the world. Consistently, Singapore ranks at the top of international lists profiling investment potential, ease of doing business, open economies, and best business environments. The government of Singapore has recently placed the development of the biotechnology sector as a top priority in the country's fiscal plans, resulting in hundreds of millions of dollars in funding for that industry. Since new regulations were introduced in 2010... Continue reading
  • 5 QUESTIONS & ANSWERS: MEDICAL DEVICE REGISRATION IN MALAYSIA

    Posted on Feb 06, 2013
    A Q&A with Jennifer Grimes on new registration requirements for medical devices in Malaysia. Under the Medical Device Regulations 2012, medical devices will have to undergo a conformity assessment before they are released into the Malaysian market, whereas they were previously registered under a voluntary scheme. To comply with legislation, authorized representatives, importers and distributors must have... Continue reading
  • 5 QUESTIONS & ANSWERS: REGISTRATION IN THE MIDDLE EAST

    Posted on Jan 23, 2013
    A Q&A with Mr. Idan Vivante on opportunities and challenges posed by the medical device market in the Middle East. In many of these developing markets, investment in health is constantly rising through local and foreign interest in the health sector. In particular, Western capital is invested in many countries in order to develop public services in general and the health system in particular. Add this to the domestic capital in places like Saudi Arabia, United Arab Emirates, and other countries with large quantities of natural resources and there is big potential for the medical device and... Continue reading
  • COUNTRY AT A GLANCE: SAUDI ARABIA

    Posted on Jan 23, 2013
    With an annual health budget of over $16 billion USD, Saudi Arabia is rife with opportunity for medical device manufacturers. As with most of the Arab world, the country’s approximate population of 28 million has a rapidly growing demand for medical devices with the government investing significantly in the private and public health sectors to match this demand. Though the Saudi regulatory body (SFDA) is relatively new and operating on an interim regulatory system with changing requirements... 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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