By David Solomon

High-quality foreign medical devices might soon have a faster path to approval in the developing China market. Recently released draft rules that call for expedited review of certain medical devices should benefit US companies in China. However, competing regulations appear to favor domestic devices, as the vast majority of applications moved into the priority status during the trial of the program were domestic.

China’s medical device sector has grown by 20 percent annually since 2009 to make China the second-largest market in the world. The United States is the largest exporter of devices to China, with many firms motivated to invest in a market with an aging population and greater discretionary income. This evolving approval pathway would enable US companies to expedite review of their devices.

Priority review pathway for “breakthrough” medical devices

Class II and III imported devices and Class III domestic devices can obtain priority status for registration applications if the technology is urgently needed for clinical use and differs from existing registered products, according to details of the China Food and Drug Administration (CFDA)-proposed priority review pathway.

These devices may also obtain priority status if the product is proven to:

  • Have obvious therapeutic advantages in diagnosing or curing rare diseases or malignant tumors; or
  • Diagnose or cure elderly-specific or children-specific diseases that cannot be effectively diagnosed or cured with current methods.

Impact of Chinese localization policies on foreign medical device approval

Although these expedited reviews are encouraging, they appear to disproportionately benefit domestic companies. Less publicized concurrent policies suggest preferential treatment for domestic manufacturers that could undermine the benefits of this new process.

Only four of the 67 devices approved for priority review from February 2014, when the CFDA trial began, through July 2016 were foreign manufactured. This imbalance suggests CFDA is using the priority review pathway to favor Class III domestic devices over Class II and III foreign devices. Specific reports for each approved device under this pathway are available on the China Medical Device Evaluation website, but do not provide additional detail about what distinguished the priority-approved devices from those that were not fast tracked.

This outcome is somewhat expected, since State Council’s September 2015 Technical Guidance of Key Sectors under Made in China Roadmap broadly emphasized China’s intentions to protect its domestic healthcare sector and blamed foreign brand dominance in the Chinese high-end medical device market for increasingly expensive domestic healthcare costs.

The government listed medical devices as one of 10 industries targeted for major development by 2025. China aims to raise the profile of domestic brands by propelling at least five to become internationally respected brands and ensuring that county hospitals nationwide use domestically produced medical equipment.

These vague, yet pointed, policies suggest that foreign device manufacturers seeking to register products through the priority review channel may face additional challenges. USCBC will continue to monitor developments.

Posted by David Solomon