Established in November 2008, the Office of Global Policy and Strategy's (OGPS) 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.
Vanessa Shaw-Dore, Director
Latasha Robinson, Deputy Director
Office of Global Policy and Strategy
U.S. Food and Drug Administration
E-mail: [email protected]
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 Administration (CFDA) now the National Medical Products Administration (NMPA), which reports to the State Administration of Market Regulation (SAMR). NMPA is responsible for conducting drug registration and approvals, 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 former General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ), now the General Administration of Customs, China (GACC). GACC is also responsible for registering companies that export. Registration includes annual inspections to ensure that registered companies exporting regulated products to the United States are compliant with U.S. requirements.
- China Office Sees Increase in Use of Misleading Medical Device Registration "Certificates" - Points the Way to CDRH Action, From a Global Perspective, March 2021
- FDA's Global Efforts to Protect Patients and Consumers from Unsafe Products, FDA Voices, November 29, 2018, (Chinese)
Online Resources for FDA Regulated Products
- Radiological Health
- Electronic Product Certification and Quality Control Testing Programs, Youku, (Chinese)
- How to Get Your Electronic Product on the U.S. Market, Youku, (Chinese)
- New Era of Smarter Food Safety Blueprint (English), (Chinese)
- FSMA Final Rule on Produce Safety (English), (Chinese)
- Importing Food Products into the United States
- Biennial Registration and DUNS guidance
- Guidance for Industry: Enforcement Policy for Providing an Acceptable Unique Facility Identifier (UFI) for the 2020 Food Facility Registration Biennial Renewal Period | FDA
- FDA Reminds Human and Animal Food Facilities About This Year’s Biennial Registration Renewal Period and Provides Updated Guidance on How to Obtain and Submit a DUNS Number | FDA
- Food Facility Registration User Guide: Biennial Registration Renewal FDA
- Foreign Food Facility Inspection Program Questions & Answers (English), (Chinese)
- Food Facility Registration User Guide: Step-by-Step Instructions
- FDA Issues Updated Guidance on Compliance and Date for Providing an Acceptable Unique Facility Identifier (DUNS number) for the Foreign Supplier Verification Programs
- MOU between FDA, HHS and Certification and Accreditation Administration of the People's Republic of China Regarding Registration of U.S. Food Manufacturers Exporting to China, June 2017
- Implementing Arrangement with CFDA, November 2014
- Implementing Arrangement with AQSIQ, November 2014
- MOU between U.S. FDA and China's Center for Food Safety Risk Assessment, December 2013
- FDA - SFDA China, Agreement on the Safety of Drugs and Medical Devices, December 2007
- FDA - AQSIQ China, Agreement on the Safety of Food and Feed, December 2007