Medical Translation Insight

India and China... Both countries are inspiring success stories and, according to a new article, are positioning themselves to play major roles in the global in-vitro diagnostics (IVD) market in the future.

China and India: Comparing Two Fast-Growing IVD Markets is a timely look at how these two countries that account for about 1/3 of the world's population stand to up-end the IVD industry. While IVDs aren't the only products feeling the heat from "Chindia", those products have seen annual growth rates of 10-20% in the recent past.

The IVD Technology article does a nice job looking at market sizes for IVD instrumentation, molecular testing, and clinical labs. It notes differences in experiences and with product registrations, for example, highlights differences:

IVD product registration is an area in which the two countries differ greatly. Product registration is going to get more difficult in India, but it still remains relatively inexpensive and rapid. India's government is making changes in the regulations for medical devices and IVD products. According to industry contacts and Ministry of Health officials, a notification is expected that would bring a group of medical devices and IVDs under the regulatory framework. The authority regulating medical devices and IVDs will be the Central Drug Standard Control Organization (CDSCO) in the Ministry of Health.

In China, the situation is very different. The State Food and Drug Administration (SFDA) is responsible for regulating drugs and medical devices. Both IVD instruments and reagents must be registered, and all products must be re-registered every four years.

If you want a piece of good news, then jump to the end of the article, where the author concludes that "[a]s long as the two main market drivers—increasing prosperity and urbanization—continue, strong growth in the Chinese and Indian IVD markets is expected for many years." [Hat tip to Mel Faux!] For more on this topic, take a look at:

• China's IVD market is booming
• Medical devices & IVDs in the world's 2nd largest economy
• Growing importance of India, China for medical device, pharmaceutical firms

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