China Tightens Export Management of Selected Devices and Drugs

On October 28, 2008, China’s State Food and Drug Administration (SFDA) announced the implementation of a “catalog management” system for a list of specified medical devices and drugs. This is part of a Chinese effort to extend regulation to exported medical products in addition to products sold on the Chinese market.

In the new catalog system, a number of medical products will routinely be checked upon leaving China. They will need to have appropriate product registrations as well as GMP approval of their manufacturing sites. Additionally, manufacturers of specified drugs (but not specified devices) will need to obtain export sale certificates.

All medical device and drug manufacturing in China officially requires SFDA approval. However, enforcement of the laws for export-only products has historically been relatively weak, because exported products were not checked for SFDA approvals.

Only a limited number of medical products will be subject to catalog management at first. The medical devices specified by the catalog management system are glucose test strips and condoms. The specified drugs are gentamicin sulfate, atorvastatin, sildenafil (Viagra), oseltamivir (Tamiflu), cefoperazone, ceftriaxone, artemisinin and its derivatives, and heparin. This list includes products with particular safety concerns, such as heparin, whose Chinese exports have caused dozens of deaths in the US.

The SFDA will be working with the help of the US FDA to regulate these products. If successful, this initiative will be extended to a wider range of products and should increase the safety and quality of medical devices and drugs that Western companies import from China.