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China to Down-Classify IVD, Imaging Devices; Other Reforms Are Expected

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China is expected to reclassify some in vitro diagnostic (IVD) and medical imaging devices to lower-risk categories as part of a reform of its classification system that began in 2009, industry experts say.

The country promised to reclassify the products at the U.S.-China Joint Commission on Commerce and Trade (JCCT) Outcomes meeting in November 2011, Nancy Travis, AdvaMed’s vice president of global strategy and analysis, said.

The proposal came in response to a U.S. government request that China consider down-classifying certain categories of diagnostic products, based on industry input showing the products are classified into higher-risk categories in China than in most other countries, Travis said. As a result, China’s State Food and Drug Administration agreed to issue a complete list of X-ray equipment to be down-classified. The agency also said it would attempt to release a draft IVD equipment catalogue for public comment, according to a U.S. government fact sheet. Both actions are expected this summer.

Certification of products that are downgraded will continue in effect until reregistration, when the device will be certified under the new classification, and the SFDA’s chief concern is in implementing the reclassifications.

Other regulatory reforms are also on the horizon. The SFDA plans to establish a medical device re-evaluation system for high-risk devices, Helzer said. The new system will include focused monitoring, formulation of technical specifications and completion of a postmarketing safety risk analysis report for each device.

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