Articles

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  • 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
  • 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

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