Quality Control on Coronary Stents Increased Following China’s Recent Centralized Procurement Program

On November 11, the NMPA (National Medical Products Administration) announced (No.103 – 2020) six principles to strengthen the market surveillance of coronary stents following the recent implementation of a centralized procurement in China.

In summary of the six principles, the NMPA advises the provincial MPAs to ensure the manufacturers:

• Meet the product standards for quality and safety
• Strengthen the inspection over the manufacturing process
• Supervise the circulation of coronary stents
• Establish a traceability system for product recalls
• Effectively control post-market risks with adverse events monitoring
• Reinforce the coordination and communication between internal departments

Highlights from the Centralized Procurement of Coronary Stents

On November 5, the Chinese government held a conference meeting at Tianjin city in China to unveil the results of the centralized procurement of coronary stents.  

• Ten varieties of coronary stents from eight enterprises won the bidding including Boston Scientific and Medtronic
• In comparison to 2019, the average price of the coronary stents has decreased by 93% from approx. 13,000 rmb to approx. 700 rmb
  • 92% decrease for the average price of domestic products
  • 95% decrease for the average price of importing products
• The procurement program saved up to 10.9 billion rmb.
• All the patients in China will expect to be treated with the procured coronary stents by January 2021.

Important Takeaways for Manufacturers

Coronary stents are mainly used to treat patients with cardiovascular diseases (CVD), which is ranked as the third most fatal disease type in the Chinese population. Becuase some people expressed concerns about the quality of the final product following the centralized procurement implementation, China has released six principles (as mentioned above) to reinforce the quality control of the stent products. In addition, China’s NHSA (National Healthcare Security Administration) has confirmed that the enterprises of all winning bids had successfully passed the national quality tests, and the stents could be traced for post-market surveillance.

The procured coronary stents are expected to be ready in China by January 2021, but available for treatments in public hospitals only. Based on the government measures and plans up until now, private hospitals in China will remain unaffected by the centralized procurement.

By Jacky Li. Contact Cisema if you would like to learn more.