Articles

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  • 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
latest news
  • 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®. ...

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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. ...

    Read More
  • Apr 4 2017
    ARAZY GROUP OFFERS QMS UPGRADE TO ISO 13485:2016 STANDARD

    In line with its commitment to making safe and effective IVD and medical devices available worldwide, regulatory affairs firm Arazy Group Consultants Inc. is assisting MedTech manufacturers in meeting the deadline to upgrade their quality management syste...

    Read More

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