Ensuring that product labels and instructions comply with the regulatory requirements of the target market is crucial when exporting personal lubricants. Here are some key details that exporters need to pay special attention to when preparing labels and instructions:
1. Clear Product Information
Labels should include information such as product name, purpose, ingredients, usage methods, and precautions. This information must be written in understandable language and ensure that the characteristics and uses of the product are accurately conveyed.
2. Compliance with Local Regulations
Different countries and regions have different requirements for the labels and instructions of personal lubricants. Exporters must ensure that the labels and instructions comply with the regulatory requirements of the target market, including any specific warnings or statements.
3. Raw Material Safety
The safety of raw materials should be clearly indicated on the label, ensuring that the materials used meet relevant safety standards. For example, the raw materials for water-based personal lubricants should meet drinking water quality standards, while those for silicone-based personal lubricants should meet medical-grade silicone oil standards.
4. Production Process and Quality Control
Instructions should mention the production process, including confirmation and verification data of special processes and key steps. At the same time, an effective quality control system should be established to ensure the stable and reliable quality of the product.
5. Warning Information and Precautions
Labels and instructions must include warning information and precautions, such as contraindications, special precautions, possible adverse events, and handling measures. This information helps users use the product safely and reduces potential risks.
6. Language and Expression
The language of the instructions and labels should be clear and accurate, providing complete information about usage steps, environment, limitations, and adverse reactions. The content of imported product instructions should be faithful to the original text and provide a complete version of the original instructions, labels, and Chinese translations.
7. Packaging and Labeling
Product packaging and labeling should comply with the requirements of the Medical Device Instructions and Label Management Regulations. Packaging labels should include general information about the product and schematic diagrams, specifying the recommended sizes for endoscope forceps channels compatible with each model of endoscopic injection needles.
As a professional manufacturer of personal lubricants, Pingchuang Medical deeply understands the importance of labels and instructions. Pingchuang Medical's product labels and instructions are strictly designed and produced according to the GMP production system. The company adopts a fully automated assembly line, from raw material testing to semi-finished product testing, to final product factory testing, ensuring that products meet high standards.
