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CFDA: The CFDA Implements New Guiding Opinions on Enhancing the Construction of Food and Drug Inspection and Testing System

2. April 2015

The Chinese certification authority CFDA (China Food and Drug Administration) has been in existence since 2013, replacing the institution that was formerly known as SFDA (China State Food and Drug Administration). The CFDA is a division of the State Council of the People’s Republic of China and is responsible for monitoring and processing the registration and certification of food, drugs, cosmetics, medical products and medical devices in the People’s Republic of China.

Manufacturer of medical products and devices are required to apply for CFDA registration before their products are eligible to enter the Chinese market.
Chinese Female Woman Scientist & Microscope In LaboratoryIn December of 2015 the ministers of the CFDA met to work out new guidelines for enhanced inspection procedures and testing systems for food and drugs in China. As a result of the meetings they published “New Guiding Opinions on Enhancing the Construction of Food and Drug Inspection and Testing System” in January 2015. The document defines the hierarchical structure within the agency for food and drug inspection. The structuring was set as follows:

Four-level structure of inspection agencies for food and health food

  • State
  • Province
  • City
  • County

Three-level structure of inspection agencies for drugs and cosmetics

  • State
  • Province
  • City

Two-level structure of inspection agencies for medical products and devices

  • State
  • Province

The new Guiding Opinions will improve the inspection system creating more transparency within the different hierarchical levels.

If you would like to know more, have questions or concerns, please contact us any time by phone or email.

 

MPR Author

About the author: Julian Busch is founder and managing director of MPR China Certification GmbH
Publisher: MPR China Certification GmbH

Tel.: +49 69 271 37 69 150

E-Mail: info@china-certification.com
Web: www.china-certification.com