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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’s science-based regulations and requirements;
- Conducting risk-based, commodity-specific inspections to meet the requirements of FDA’s 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 third 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 former China Food and Drug…
Continue lendo em https://www.fda.gov/about-fda/office-global-operations/china-office
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