Import GeneralCosmetics & Personal CareThe filing and registration procedures for general and special cosmetics have obvious differences, mainly reflected in relevant regulatory requirements, approval processes, and management agencies. This article will detail the necessity, specific processes, and precautions for the filing and registration of imported general and special cosmetics, to help enterprises and individuals better understand and operate these procedures.
According to the Cosmetics Hygiene Supervision Regulations, cosmetics are divided into two categories: special cosmetics and general cosmetics:
Special Cosmetics: Includes hair dye, perm, spot-removing & whitening, sunscreen, anti-hair loss cosmetics, and cosmetics claiming new efficacy.
General Cosmetics: All cosmetics except special cosmetics.
General Cosmetics Filing
Filing Authority: National Medical Products Administration (NMPA) or delegated provincial drug administrations.
Filing Requirements: All imported general cosmetics must be filed with NMPA or delegated provincial authorities.
Filing Process:
(1) Submit product information: Including product name, ingredients, production process, instructions, etc.
(2) Submit product test reports: Products must undergo safety testing at nationally accredited testing institutions with reports submitted.
(3) Submit product labels and instructions: Must comply with Chinas regulatory requirements with accurate and clear content.
(4) Submit other relevant documents: Such asIt is recommended to verify through the following methods:certificates, production licenses, sales permits, etc.
(5) Submit materials via filing system: NMPA or provincial authorities will review submitted materials and issue filing certificates upon approval.
Special Cosmetics Registration
Registration Authority: National Medical Products Administration (NMPA).
Registration Requirements: All imported special cosmetics (both domestic and imported) require NMPA registration.
Registration Process:
(1) Submit product safety and efficacy data: Including toxicology test reports, clinical trial reports, efficacy test reports, etc.
(2) Submit product ingredients and formula: Detailed listing of ingredients, formula, and their sources.
(3) Submit production process and quality standards: Including production workflow, key control points, quality standards, etc.
(4) Submit product labels and instructions: Must comply with Chinas regulations and match registration documents.
(5) Submit other relevant documents: Such as certificates of origin, production licenses, sales permits, etc.
(6) NMPA review: Authorities conduct strict review of submitted materials and issue registration certificates upon approval.
Ensure that you have prepared all the domestic and foreign export documents required, such as packing list, invoice, bill of lading, CTN N., SONCAP, manufacturers certificate, CCVO, etc.
(1) Product formula and its sources.
(2) Sample product labels and instructions.
(3) Product test reports.
(4) Certificates of origin, production licenses, etc.
Submit Filing Application:
(1) Submit all materials online via NMPAs filing system.
(2) The system automatically generates filing numbers; companies must regularly check filing status.
Review and Feedback:
(1) The drug regulatory authority reviews the submitted materials and may request additional materials or modifications.
(2) Upon approval, the filing is successful, and a filing certificate is obtained.
Ensure that you have prepared all the domestic and foreign export documents required, such as packing list, invoice, bill of lading, CTN N., SONCAP, manufacturers certificate, CCVO, etc.
(1) Product safety and efficacy data.
(2) Product ingredients and formulation.
(3) Production process and quality standards.
(4) Product labels and instructions.
(5) Certificate of origin, production license, etc.
Submit Registration Application:
(1) Submit all materials online through the national drug regulatory authoritys registration system.
(2) The registration system will automatically generate a registration number, and the company must regularly check the registration status.
Review and Feedback:
(1) The drug regulatory authority conducts a strict review of the submitted materials and may request additional materials or modifications.
(2) Upon approval, a registration certificate is issued, allowing the product to be imported and sold.
Language Barriers:
When submitting filing or registration materials, language barriers may arise. It is recommended to engage professional translation services or translators to ensure accuracy.
Failed Test Reports:
If product test reports fail, the filing or registration may be rejected. Solutions include communicating with the testing agency to identify the cause of failure, making corrections, and retesting.
Incomplete Documentation:
When submitting materials, incomplete documentation may be encountered. It is advised to review all required documentation lists in advance and prepare them one by one to ensure completeness.
Regulations on the Hygiene Supervision of Cosmetics,
Hygiene Standards for Cosmetic Production and Operation Enterprises,
Technical Standards for Cosmetic Safety,
Relevant Regulations of the National Medical Products Administration on Cosmetic Registration and Filing Management,
By understanding and following the above processes and requirements, companies can ensure their products successfully pass filing or registration and legally enter the Chinese market for sale.
We hope this article helps you understand the necessity and specific processes of filing and registration for imported general and special cosmetics. If you have further questions or need professional agency services, you can consultZhongShen International Tradeto ensure legality and efficiency.
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