INDUSTRY NEWS
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The market for clinical diagnostics in China by testing area. Source: McEvoy & Farmer (San Francisco), Kalorama Information (New York City). |
In becoming a member of the World Trade Organization (WTO) in 2001, China agreed to comply with various provisions, which has been beneficial to foreign companies doing business in the country. The most important provisions for IVD companies have been the reduction of tariffs and the ability of foreign firms to control their own distribution in the future.
One of the biggest challenges of the IVD market in China is figuring out how to navigate the maze of complex and unfamiliar regulations. In 1998, the regulation of drugs and medical devices was moved from the Ministry of Health (MOH) to the State Food and Drug Administration (SFDA).
Two different SFDA branches have been involved to some degree in IVD product registration in China. One branch is responsible for drugs, while the other oversees medical devices. After these two branches battled for several years over which one should regulate IVDs, it was decided in 2004 that the drug section is the proper authority for registering IVDs.
While the proper regulatory authority for IVDs in China is now known, product registration has not become any easier; on the contrary, it seems to have become more difficult. IVD companies have reported shifting requirements and new problems being raised over previously registered products.
While product registration is required for all IVDs sold in China, many IVDs are currently sold without registration or while registration is still being processed. Even though enforcement varies, it remains clear that IVD product registration is a more important issue to large companies, especially foreign firms. While small distributors or small local manufacturers are unlikely to be the focus of SFDA fines, larger companies know that SFDA authorities will be watching them closely.
IVD product registrations must be done by a local company, which may be either a local Chinese company or a branch of an international firm that has a legal presence in China. The registration establishes the legality of a product to be sold in China and used by different distributors.
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Figure 1. IVD market growth in China, 1995–2004. Source: McEvoy & Farmer, Kalorama Information. |
To register a new IVD in China, an IVD manufacturer must submit samples of its test to the National Institute for the Control of Pharmaceutical and Biological Products (NICPBP). If the test being registered is already on the market, the NICPBP has previously established a standard for it to be measured against. In the case of a new test, the company registering the test will work with NICPBP to develop a standard.
At the same time, an IVD company applying for product registration in China must conduct a clinical study with a major laboratory. The results of this study, along with the results from the NICPBP and other required paperwork, are then submitted to SFDA for approval.
The costs of this process are $6000–$12,000 in fees to SFDA and NICPBP, and $35,000– $60,000 for the clinical trial. While IVDs that have FDA approval or a CE mark can be registered in as few as nine months, without these certifications it can take one to two years to register an IVD in China.
After joining the WTO, China committed to make all processes such as product registration more transparent and less costly. While such changes have not yet happened in the case of IVD product registration, the authors of the report expect that they will occur, and that at some point, all IVDs sold in China will be registered at a reasonable speed and cost.
Additional information about this report can be accessed via the Kalorama Information Web site at www.kaloramainformation.com.
