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The Chinese cosmetics market is vast, but the entry barriers are relatively high, and the registration process is complex. Here's a simplified overview of the general cosmetics registration process in China. Please note that specific requirements may vary depending on the product category, region, and other factors. It is advisable to consult with a professional agency for more accurate information.
1.
- Determine Registration Type
- Non-special use cosmetics filing: For general daily skincare and makeup products.
- Special use cosmetics registration: For products with specific functions such as whitening, sun protection, hair dye, perm, hair growth, weight loss, and breast enhancement.
2.
- Prepare Registration Documents
- Product formula: Detailed product formula, including INCI names and content of all ingredients.
- Safety assessment report: A safety assessment report issued by a qualified institution.
- Label sample: A sample of the Chinese label that complies with regulations.
- Information of the manufacturing enterprise: Including the production enterprise's license, quality management system, etc.
- Information of the domestic responsible person: The agent or legal person of the applicant in China.
3.
Submit the Registration Application
- Online submission: Applications are usually submitted through the online system of the National Medical Products Administration (NMPA).
- Required materials: Upload the prepared registration documents to the system according to the requirements.
4.
- Formal Review
- Completeness check: Review whether the submitted materials are complete and in the correct format.
5.
- Technical Review
- Safety assessment: Review the product's safety assessment report to ensure the product meets safety standards.
- Formula rationality: Review whether the product formula is reasonable and the ingredients comply with regulations.
- Label compliance: Review whether the label content complies with relevant regulations.
6.
On-site Inspection (if applicable)
- Manufacturing enterprise inspection: For some products, on-site inspections may be required to verify that the production environment and process meet the requirements.
7.
Approval Decision
- Issuance of registration certificate/filing certificate: If the review is passed, the corresponding registration certificate or filing certificate will be issued.
8.
Market Launch
- After obtaining the registration certificate/filing certificate, the product can be officially sold in the Chinese market.
