China to Release Its First In-Vitro Diagnostic Reagent Regulation

Chang-Hong Whitney

According to market research firm Frost & Sullivan, the Chinese in-vitro diagnostics (IVD) market was estimated to be $500 million in 2004, with an annual growth rate of 14.4%—reaching $1.1 billion by 2010. In comparison, the worldwide IVD market was estimated at about $26.8 billion in 2003, with a growth rate of 5% to 7% annually between 2003 and 2009. 

In-vitro diagnostics use methodologies in immunology, microbiology, cell biology and other analytical theories and techniques to detect antigens, antibodies, enzymes, DNA, cancer markers and other indicators that are representative of certain diseases or conditions in the human body. In China, healthcare facilities routinely use IVD testing for diagnosis, measurement of treatment efficacy and post-treatment monitoring.

An IVD system typically consists of an instrument and reagents used to perform each test. Many manufacturers design special reagents specifically for their instruments. This practice allows companies to ensure product and performance quality (and protect the delicate components of the instrument). Furthermore, it provides a competitive advantage to suppliers, who can capture the reagent trail and lock in end users. Indeed, these instruments and the captive reagents have created unique business scenarios in which manufacturers can leverage their investment and costs through the balance of instruments and reagent trails.

Because IVD instruments have been classified as medical devices, the China registration process has been standardized along with the device regulations set by the State Food and Drug Administration (SFDA). However, reagents—due to their technical complexity—have been a difficult subject for Chinese regulators.

The SFDA published two IVD regulations in 2001 and 2002, separating instruments and reagents. For reagents, the agency had stipulated that chemistry reagents were to be registered as a medical device, whereas other reagents for antigen or antibody detection were to be registered as drugs. The latter group, therefore, had been subject to in-country clinical trials, product testing and the release of extensive reviews.

It became apparent that these regulations were too broad and vague and that the implementation of the regulations was almost impossible. Instead of streamlining the market and the regulatory process—as was intended by the SFDA—these regulations had added confusion and heavy burdens to manufacturers and created conflicts to this marketplace.

 

Chang-Hong Whitney is president of Whitney Consulting Ltd. in Massachusetts. With an MBA from Babson College (Wellesley, MA) and undergraduate degrees in electronic engineering and international business, she has been consulting for western companies on doing business in China since 1994, focusing on the medical device market. Her services include China regulatory affairs, market research, sourcing and logistics programs and China business strategies. She can be reached at [email protected].