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China Office

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CHINA OFFICE

Established in November 2008, the China Office serves as the lead for the FDA’s on-site presence in China. The mission of the Beijing-based office is to help ensure the safety, quality, and effectiveness of medical products and food produced in China for export to the United States. 

The China Offices seeks to accomplish these objectives by:

  • Promoting international health policy harmonization and regulatory convergence; 

  • Engaging with regulatory authorities, industry, academia, multilateral organizations, non-governmental organizations, and other relevant institutions to increase the FDA’s understanding of China’s regulatory framework and processes and share information about FDA science-based regulations and requirements;

  • Conducting risk-based, commodity-specific inspections to meet the requirements of FDA legislative mandates; and

  • Monitoring and reporting on regulatory trends, conditions, and emerging public health events that have the potential to impact the safety of FDA-regulated goods produced in China intended for U.S. consumption.

Focus on China

China ranks second among countries that export drugs and biologics to the United States. China also ranks first among countries that import devices to the U.S. The top three medical device imports from China are surgical drapes, non-absorbable gauze and surgical gowns.

Drugs and medical devices are overseen by the National Medical Products Administration, which reports to the State Administration of Market Regulation. NMPA is responsible for conducting drug registration and approvals and provides guidance to provincial authorities and works with provincial level investigators to assign inspections of clinical trial facilities and international inspections.

Imported and exported food are regulated by the General Administration of China Customs. GACC is also responsible for registering companies that export. Registration includes annual inspections to ensure the registered companies that export regulated products to the U.S. are compliant with U.S. requirements.
 

Online Resources in Chinese

International Arrangements

Resources For You