Articles

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  • 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
  • ONE COMPANY REGISTERS 25 DEVICES IN 13 MARKETS: A CASE STUDY OF 2012

    Posted on Jan 14, 2013
    A leading European manufacture in the field of ophthalmic devices approached Arazy group in mid-2011 to register a variety of products in various countries. This particular company planned to register over twenty five devices divided into 8 to 10 families of products in multiple markets. Their principle concern was the use of local distributors; our client required the ability to sell directly to private clinics and hospitals independently of local distributors who usually assume control of the license in that market. This task was too complex for our client on their own since they did not have the necessary infrastructure and expertise to complete their goal successfully in so many... Continue reading
  • COUNTRY AT A GLANCE: NIGERIA

    Posted on Jan 14, 2013
    Nigeria is the most populous country on the African continent. Its rapidly growing economy has made it a desirable emerging market for investors, with the second largest African stock exchange, the third largest manufacturing sector in Africa, and the 30th largest GDP (PPP) in the world according to 2011 statistics from the World Bank. To register medical devices in Nigeria, the Nigerian Ministry of Health requires foreign medical device manufacturers to... Continue reading
  • COUNTRY AT A GLANCE: LEBANON

    Posted on Dec 04, 2012
    Medical or laboratory devices and equipment do not need pre-approval in Lebanon. However, they must be approved upon entry each time the product goes through customs, even if... Continue reading
  • FDA REGISTRATION REQUIREMENTS FOR MANUFACTURERS: OUR SOLUTION.

    Posted on Nov 26, 2012
    How do you navigate changes to the USA FDA requirements? Read below for Arazy Group's solution for regulatory compliance that will remove your burden. As valued contacts of the Arazy Group, we would like to notify you of our service regarding important requirement changes from the USA FDA for the upcoming fiscal year of 2013. Continue reading
  • ARAZY GROUP LAUNCHES UNIQUE, CLOUD-BASED SYSTEM TO ACCELERATE MULTI-NATIONAL REGISTRATION OF MEDICAL DEVICES

    Posted on Nov 14, 2012
    Below is a press release regarding today's official launch of Licensale.com.

    Vancouver, BC - (Oct 15, 2012) - Leading regulatory affairs firm Arazy Group announced today the launching of Licensale.com, a novel, cloud-based, online regulatory management system which will revolutionize international compliances and licensing for both medical device manufacturers as well as national regulatory bodies. The system will provide a much needed, integrated platform for simultaneous registration in multiple markets in manner that is both time and cost efficient. Continue reading

  • 5 QUESTIONS & ANSWERS: STRATEGIC REGULATORY PLANNING FOR YOUNG MEDTEC COMPANIES

    Posted on Nov 06, 2012
    An Interview with Arazy Group President & CEO Benjamin Arazy. 2013 will not be an easy year for MedTech. Last year, MedTec investments in the United States declined by 27% compared to 2011 and this trend is expected to continue. Funding from venture capital funds for this industry have been declining due to a back log of medical device companies seeking an "exit" in the next ten years. The main difficulty will be for startups in the early stages of... Continue reading
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  • Jul 17 2017
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  • Jul 10 2017
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    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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