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                Office of Global Operations

Office of Global Operations

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          China OfficeOffice of Global Operations China Office
  
  	
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              China-Great WallEstablished 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 Office 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
	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
	Expanding upon and building better quality data to inform the FDA's regulatory decisions and actions
	Conducting risk-based, commodity-specific inspections to meet the requirements of FDA’s legislative mandates and
	Supporting the U.S. Embassy, Beijing, to ensure the coordination of U.S. government activities that are related to FDA equities.Contact Information:

Vanessa Shaw-Dore, Director
China Office
Office of Global Policy and Strategy
U.S. Food and Drug Administration
U.S. Embassy
 Tel: +86-10-8531-3000
Fax: +86-10-8531-3131
E-mail: US-FDA-CNO@fda.hhs.gov

**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

**Biologics**

	Foreign Regulatory Seminar (Web-Based): CBERs Regulation of Biologics (English), Printable scripts in: (Francais), (Espanol), (Chinese)
	**Cosmetics**
	FDA Authority Over Cosmetics: How Cosmetics are not FDA-Approved, but are FDA-Regulated (English), (Chinese), March 2022
		Is it a Cosmetic, a Drug, or Both? (Or is it Soap?) (English), (Chinese)
		Information for Cosmetics Importers (English), (Chinese)
	**Devices**
	An Introduction to FDA’s Regulation of Medical Devices, Youku, (Chinese)
		Medical Device Webinars and Stakeholder Calls
	**Drugs**
	CDER Small Business and Industry Assistance
		SBIA Resources in Chinese
	**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)
	**Foods for Humans and Animals**
	FDA Announces the Final Rule for Food Traceability Under FSMA (English),中文 (Chinese, Simplified)
		FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods
		Frequently Asked Questions: FSMA Food Traceability Rule
		New Era of Smarter Food Safety Blueprint (English), (Chinese*)*
		FSMA Final Rule on Produce Safety (English), (Chinese)
		Importing Food Products into the United States
		FDA’s Imported Food Safety Strategy
			Overview and Background of Prior Notice of Imported Foods
		How to Start an Animal Food Business (English)
		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 ProgramsInternational Arrangements

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 2007Resources For You

Contact Information: OGPS Offices
	Countries and Regions Covered by OGPS Offices
	FDA Globalization
	From a Global Perspective
	Global Updates
	Imports and Exports
	International Arrangements
	International Programs
	News, Speeches and Publications
	Partnerships and Collaboration

                                                                                  Content current as of:
      10/27/2023Office of Global Operations

          
                        Europe Office
          China Office
          India Office
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