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1.
- Product Description
- Name and Model: Include the brand name, model, etc., of the product.
- Function and Purpose: Describe the primary function and intended use of the product.
- Product Formula: Provide the list of ingredients, including the percentage of each ingredient, and specify their function.
2.
- Ingredient Safety Information
- Technical Data for Ingredients: Provide information for each ingredient such as INCI name (International Nomenclature of Cosmetic Ingredients), CAS number, source, etc.
- Safety Assessment: Include safety assessment reports for each ingredient, typically prepared by qualified professionals.
- Harmful Substances Test Reports: Provide test reports for possible harmful substances (e.g., heavy metals, prohibited substances).
3.
Product Manufacturing Process
- Production Process: Provide detailed descriptions of the manufacturing process, including each step.
- Quality Control: Describe the quality control measures and methods, including key control points in the production and quality testing procedures.
4.
- Product Label and Instructions
- Product Label: Provide the product label design, ensuring it meets the standards of the importing country (e.g., ingredient listing, warning statements).
- User Instructions: Prepare the user manual, explaining how to use the product correctly, and listing potential precautions and contraindications.
5.
- Stability and Microbiological Test Reports
- Stability Testing: Provide stability test reports to demonstrate the product's stability within its shelf life.
- Microbiological Testing: Provide microbiological test reports to ensure the product is free from harmful microorganisms.
6.
Responsible Person Information
- Responsible Person Details: Provide information about the person or company responsible for the product on the market, including address and contact details.
- Legal Liability Statement: Specify who holds legal responsibility for the product’s quality and safety.
7.
- Post-Market Surveillance
- Adverse Reaction Monitoring Plan: Describe how to monitor the product’s performance in the market, especially the collection and reporting of adverse reactions.
- Consumer Complaint Handling Procedures: Explain the process for handling consumer complaints.
8.
Compliance with Relevant Regulations
- Regulatory Compliance Statement: Provide documentation declaring that the product complies with the regulations of the importing country or region.
- Test Certificates: If required, provide certificates of compliance from third-party testing agencies.
Important Notes
- Document Updates: PIF should be updated regularly, especially when there are changes in the product formula or manufacturing process.
- Compliance Requirements: Compliance requirements vary by country, so make sure you are familiar with and adhere to the specific regulations of the importing country.
Preparing a PIF may require professional knowledge and experience; it is advisable to collaborate with professional agencies to ensure the accuracy and compliance of the documentation.
