Articles

Browse our regulatory articles below or search through our archive.

 


 

  • THE GCC HEALTHCARE MARKET SERIES: SAUDI ARABIA

    Posted on Jun 29, 2016
    This article is the first of a series on the healthcare and medical device markets in The GCC countries. Continue reading
  • CLIENT AT A GLANCE: PATIENT POCKET

    Posted on Jun 29, 2016
    When it comes to safety devices, the LaserDock® is truly one of a kind. It is the only laser fiber safety product on the market. Designed for single use, this ingenious creation of Patient Pocket LLC received Food and Drug Administration (FDA) clearance (K152636), through cloud-based global product registration service LICENSALE®. Continue reading
  • ONE BIG IMPROVEMENT TO MEDTECH REGISTRATION IN RUSSIA

    Posted on Sep 16, 2015
    The Russian regulatory system is notoriously difficult, lengthy, and expensive. This is in large part due to the fact that Russian authorities under Roszdravnadzor require local testing in Russian hospitals and testing facilities in addition to foreign clinical evaluation and EMC and IEC tests reports.

    As of July 17, 2015, Class I devices in Russia have been given a simplified, shorter regulatory pathway for regulatory authorities and manufacturers alike. While previously most Class I devices, sterile devices in particular, had to go through costly and time-consuming local clinical testing even if they have valid documentation of testing conducted elsewhere, this requirement has now... Continue reading
  • 5 BIG QUESTIONS (& ANSWERS): SAUDI ARABIA’S NEW OFFICIAL REGULATORY SYSTEM

    Posted on Jul 22, 2015
    The SFDA (Saudi Food and Drug Administration) did not regulate medical and IVD devices prior to the introduction of the interim system in 2012. New requirements have been phased in since that time and all medical and IVD (in vitro diagnostic) devices will need Medical Device Marketing Authorization (MDMA) from the SFDA by the end of 2015. The last devices to be phased in are low-risk medical devices (by December), while an MDMA is mandatory for low-risk IVD devices as of... Continue reading
  • COUNTRY AT A GLANCE: ECUADOR

    Posted on Jul 09, 2015
    Ecuador’s regulatory framework has undergone significant changes over the past five years across several sectors. For medical devices, this has altered the regulations themselves and the regulatory oversight and enforcement bodies. Some research agencies have reported that the increased regulation, notably regarding price control and importation restrictions, has negatively affected international business opportunities in Ecuador.

    However, success in improving health services has created significant opportunities for medical tourism and other areas, especially as more than half of healthcare market spending remains in the private sector... Continue reading
  • KEEP YOUR 510(K) APPLICATION ON TRACK: 3 QUESTIONS TO ENSURE UDI COMPLIANCE

    Posted on Jun 11, 2015
    The phase-in of the Universal Device Identifier (UDI) program by the US FDA begins its second phase this September, marking a grey area for manufacturers of Class II medical devices. UDI labels allow manufacturers and regulatory bodies to effectively mark and identify medical devices through a globally harmonized system for improved traceability and patient safety. The United States introduced the law, which will be implemented over seven years, in 2013.

    It is sometimes unclear, however, when and how medical and IVD device manufacturers should conform to UDI. Some large companies have been using the UDI system for years, but many smaller companies have not. Under new regulations, 510(k) applications submitted with non-UDI labelling may be delayed during the 510(k) review if the UDI due date for the device type becomes a requirement during the 510(k) review.

    Manufacturers with Class II devices should ask three questions... Continue reading
  • COUNTRY AT A GLANCE: BRAZIL

    Posted on May 28, 2015
    As both the fifth largest and fifth most populous country in the world, Brazil covers 8.5 million square kilometres and is home to 203 million people. Though per capita spending is low due to a concentration on spending in urban areas, the country’s large population means that its healthcare market – Latin America’s largest – is already of major significance and has huge potential for further growth.

    As a result, Brazil’s medical device market was estimated to be worth USD $5.6 billion by Espicom in 2013 and is expected to grow at a CAGR of 13.3% between 2013 and 2018, reaching an estimated USD $10.6 billion. Continue reading
  • 5 QUESTIONS & ANSWERS: THE CANADA-EU COMPREHENSIVE ECONOMIC AND TRADE AGREEMENT (CETA) & THE MEDTECH INDUSTRY

    Posted on Apr 16, 2015
    An interview with Josh Smith, Manager with International Trade Policy at the Government of British Columbia, Canada. CETA refers to the Canada-EU Comprehensive Economic and Trade Agreement (CETA), which is Canada’s most ambitious trade initiative to date and has a scope that is broader than the historic North American Free Trade Agreement (NAFTA). When it comes into force, Canada will be the only G7 country to have preferential access to... Continue reading
  • COUNTRY AT A GLANCE: SPAIN

    Posted on Apr 16, 2015
    The Kingdom of Spain, a constitutional monarchy and member of the European Union, is located in southwestern Europe along the Mediterranean Sea and the Atlantic Ocean and bordered by Portugal, France, and Andorra. Spain is the second largest country in the European Union and has the fifth largest economy. Famous for its mountains, coastlines, rivers, and vibrant culture, Spain's population of 46.6 million enjoys one of the highest life expectancies in the eurozone.

    Spain has the fifth largest medical device market in Western Europe and the 12th largest market worldwide, valued by Espicom at USD $4.9 billion in 2013. Three quarters of medical devices are... Continue reading
  • 5 THINGS TO KNOW ABOUT UPCOMING FDA GUDID REQUIREMENTS

    Posted on Mar 26, 2015
    An interview with Raymond Kelly, Chief Regulatory officer at Arazy Group Consultants Inc., on upcoming requirements for the US FDA GUDID program. The Global Unique Device Identification Database (GUDID) is a publicly searchable database administered by the U.S. Food and Drug Administration (US FDA) that serves as a reference catalog for every device with an identifier. Identifiers are intended to support post-market activities such as reporting, monitoring, analyzing adverse event reports, and recalls. The UDI law is being introduced based on device risk classification with the highest risk (Class III) devices required to comply by September 24, 2014 and the lowest risk devices by... 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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