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CFDA certification

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CFDA certification
Distribution Products Procedure Consultation

Distribution

Distribution

Introduction of CFDA Certification

LULU COSMETICS supports CFDA product registration and certification of Korean companies in collaboration with Chinese RA professional partner company.

CFDA (China Food and Drug Administration for Cosmetics)

  • Dr. Lunika
  • Chinese RA specialized partner company
대상품목

Products

01Cosmetics

Definition of cosmetics

 
Cosmetics are mixtures of chemical compounds or precise chemical compound products used to enhance the appearance of the face or fragrance or texture of the body (skin, hair, nail (toenail), lips, tooth, etc.) by applying or spraying to the face or body.

Types of cosmetics

Types of cosmetics
Classification Types
Non-special cosmetics (general) Products except for special cosmetics (9 types), out of products defined as cosmetics including skin care, hair care, makeup, lips protection, nail and toenail products, diffuser products
Special cosmetics Depilation products, hair-dyeing products, perm products, shaving products, breast products, body shaping products, deodorization products, freckle removal (whitening) products, UV protection products

02Medical device

Definition of medical device

 
Medical devices include devices, facilities, instruments, vitro diagnostic test products, calibration/correction products, materials and relevant items, and computer software that works directly or indirectly in the body. Mostly, it works physically and not pharmacologically, immunologic, or in a metabolic way.

Classes of medical devices

Classes of medical devices
Class Type
Class 1 Medical devices recognized for their safety and validity through ordinary management
Class 2 Medical devices that requires extra management to ensure safety and validity
Class 3 Medical devices that requires thorough management of their safety and validity as they are used as a survival mechanism or inserted in the body, or have potential risk for the body.

Definition of food for health use

 
Food that provides nutrition to specific or ordinary consumers or adjusts functions in the body, and that is not for the treatment purposes and without acute or chronic risk to the body.

Classes of food for health use

Classes of food for health use
Classification Type
Registration Vitamin and mineral supplements out of health food imported into China for the first time
Permission Imported health food with the following functionality (excluding vitamin and mineral supplements)
  • 1Increase the level of immunity
  • 2Improve blood triglycerides
  • 3Help adjust blood sugar
  • 4Antioxidant effect
  • 5Improve memory
  • 6Mitigate eye fatigue
  • 7Facilitate discharge of lead
  • 8Improve throat health
  • 9Improve sleep disorder
  • 10Facilitate production of milk
  • 11Improve fatigue
  • 12Mitigate nervousness
  • 13Supplement dieting
  • 14Increase bone density
  • 15Improve nutritional anemia
  • 16Protect liver injury
  • 17Facilitate skin health
  • 18Improve stomach heath
Procedure

Procedure

01Advice agreement
  • Basic examination and study of previous materials
  • Review of class, schedule, availability, and cost
02Agent agreement
  • Entering into delegation agreement
  • Submission of work plan (within 15 days)
03Preparation of materials
  • Entering into delegation agreement
  • Submission of work plan (within 15 days)
04Product test (detection)
  • Request for testing and detection by test institution
  • IRB (clinical) approval
05Request for permission certificate
  • Submission of registration materials
  • Technical evaluation (supplement)
  • Administrative review
06Certificate
  • Receipt of Certificate
Lead time
In the case of general cosmetics/medical devices (Class 1) and food for health use (registration), it takes four to six months after an agent agreement is entered into, which also may be subject to change supplement matters and administrative procedures. In addition, in the case of other products, lead time should be estimated considering individual characteristics of products.
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