Global View: Talking Harmonization And China With Jeffrey Gren
This article was originally published in The Gray Sheet
The just-retired Commerce official Jeffrey Gren discusses the impact of globalization on the medical device industry, and the issues the sector is facing in China, in an interview with “The Gray Sheet.” Gren retired from the U.S. Department of Commerce in January after decades of focusing on device and drug trade issues.
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The original draft of an accelerated approval policy in China for innovative devices included a condition that a product being considered for the special pathway “is produced in China.” That condition has been removed from the latest draft following pressure from the U.S. government.
Thirty manufacturers have used FDA’s ISO 13485 voluntary audit program since the two-year pilot began last June, freeing up scarce agency inspectional resources to be used elsewhere. However, it will likely be eventually absorbed by a pilot Medical Device Single Audit Program currently under development by the International Medical Device Regulators Forum.
China’s county-level public hospitals may be required to participate in provincial bidding to purchase medical devices like stents and pacemakers, putting pricing pressure on multinationals such as Boston Scientific, Medtronic and Abbott Laboratories and domestic manufacturers like MicroPort Scientific.