Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Regulatory Strategy for an efficient launch of medical devices - a distinct focus on BRICS and MIST countries ***

Melanie Rosslan (Abschlußjahr: 2014)

Summary
Language:    English
During the last decades companies focused their business on major regions and countries, like the European Union (EU), the United States (US) and Japan. The saturation in these developed markets urges companies to expand to countries outside these regions. This approach can also be observed in the pharmaceutical industry: By the year 2016, the worldwide pharmaceutical market will amount to 1.2 trillion US Dollars. While the share of the developed markets will decline to 57 percent of the total global spending - starting from 70 percent in the year 2009 - the emerging markets will increase by ten percent over the next years and thus account for about 30 percent. Doing business in emerging markets is therefore inevitable for pharmaceutical companies as these countries contribute tremendously to profitability and are even expected to carry industry growth over the next years.
Although in the year 2012 developed markets still dominated the medical devices sector by representing over 75 percent of total global sales, emerging countries are subject to much higher growth rates, which are two to five times as high as those in the developed markets. Emerging markets are even considered as one of the most important driving forces for growth in the area of medical devices and will even be responsible to balance the downward trend in some of the developed markets over the next years. Considering this outlook, it is important to understand these markets with regard to their local legislations for medical devices. While in the developed markets regulatory provisions and systems are well established in the area of medical devices, emerging markets are rather heterogeneous regarding medical device regulations and regulatory processes.
The objective of this Master Thesis is to define the regulatory environment for Medical Devices in two representative groups for emerging countries: BRICS and MIST. These names stand for the first letter of each of their member states. BRICS covers Brazil, Russia, India, China and South Africa and MIST stands for Mexico, Indonesia, South Korea and Turkey. This work comprises regulatory provisions like registration requirements and processes, but also guidelines as well as predictive approval timelines. With these facts a regulatory strategy is developed and possible risk factors are identified. To establish a foundation of regulatory requirements for medical devices, the regulatory environment in the European Union and the United States are outlined.

Pages: 52, Annexes: pages: 14