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  • Need to Catch up Changes in China Food and Drug Administration’s Certification System

    Need to Catch up Changes in China Food and Drug Administration’s Certification System

    - KITA’s ‘The Changes in CFDA Certification System’ requests Korean companies’ fast responses -


    Due to the rapid growth of the beauty and health industries in China, the period to have certification of the China Food and Drug Administration (CFDA)’ of has been gradually shortened. Therefore, Korean companies’ thorough responses are required.


    According to a report titled ‘The Changes in CFDA Certification System’ issued by Beijing Center of the Korea International Trade Association (Chairman, Kim Young-joo) on May 2, as China's cosmetics, health functional foods, medical devices and pharmaceuticals markets rapidly developed, the CFDA certification amendments have been continuously announced from last year until this year. In particular, the period to register has been shortened as the license system in the past is gradually changing to registration system. However, the criteria, including product quality, formulation conditions and packaging are becoming stricter.


    According to the report, Korea took up 26.5 percent of China's total cosmetics imports last year and became the largest cosmetics importing country, beating France (24.1%).  The CFDA certification used to be the biggest obstacle in the past for Korean cosmetics companies to enter into the Chinese market. However, from March 1, last year, registration system for non-special cosmetics was tested in Pudong, Shanghai.  The registration system has been extended from March 12 to the end of this year in 10 free trade zones such as Tianjin, Guangdong, Chongqing and Sichuan.


    In the case of health functional foods, since July in 2016, nutrient supplements have been registered under registration system, and other health foods have been managed under certification system. Since July last year, the period required for registration has been significantly shortened from two to three years to one year. In addition, from this year, registration system of product formulation for infant formula is newly implemented and it will be expanded to delicatessen for special medical purposes from next year.


    It is expected that China’s imports of medical devices will increase sharply as the use of overseas clinically tested data in the field of medical devices is allowed from this year. However, overseas medical device manufacturers are required to additionally fill in the companies’ names in Chinese when applying for certification or extending certification or changing or registering permits.


    In order to launch new drugs and meet clinical demand, China partially relaxed regulations on clinical tests of multinational drugs in October last year. Also, for innovative drugs such as new drugs and biopharmaceuticals

    China has changed the system to allow clinical tests and introduction in China without permission for overseas release. In contrast, the regulations on packaging materials for medical supplies have been strengthened to apply for certification together with medical supplies.


     Shin Ki-won at Beijing Center of the Korea International Trade Association, said It is expected that the CFDA certification system in China will continue to be improved with the growth of the related industries. He also stressed In order to get the first chance in China, where the competition of global companies is severe, it is necessary to quickly recognize the institutional changes and preemptively respond to them.

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