In export trade, personal lubricants, as products for special use, need to meet a series of specific requirements to ensure market compliance and consumer safety. Here are several key points that personal lubricants need to pay special attention to during export:
1. Regulatory Framework and Requirements
Personal lubricant products are subject to strict regulatory oversight in various countries, including cosmetic regulations, medical device regulations, and related health and safety standards. These regulations require that products comply with specific safety standards and go through registration, approval, and certification processes before they can enter the market for sale.
2. Registration and Approval Process
In most countries, personal lubricant products need to undergo registration and approval. This includes submitting detailed product information, formulas, manufacturing processes, quality control measures, and reports on safety and efficacy assessments. Regulatory authorities will comprehensively evaluate these materials to ensure that the products comply with relevant regulations and standards.
3. Safety Assessment and Quality Control
Regulations require safety assessments of personal lubricant products, including testing for ingredients, microbial indicators, heavy metal content, etc. Additionally, product quality control is crucial for ensuring market compliance, encompassing quality control during production and inspection of the final product.
4. Labeling and Instruction Manual Standards
Product labels and instruction manuals are important means for consumers to understand the product, hence they are clearly regulated by law. Labels and manuals must accurately describe the product's ingredients, usage methods, precautions, and other information to ensure correct usage by consumers.
5. Export Qualification Verification
Companies must first ensure they have the right to engage in import and export activities, which requires registration with administrative departments for industry and commerce as enterprises with import and export rights. Additionally, lubricants fall under the category of goods managed by national licenses and must obtain an export license. Companies can apply for an export license from the Ministry of Commerce and its local branches.
6. Preparation of Required Documents
When exporting personal lubricants, it is necessary to prepare documents such as MSDS (Material Safety Data Sheets), dangerous goods certificates (if classified as hazardous chemicals), product performance sheets, packing lists, invoices, and export contracts.
7. Regulatory Conditions
Lubricant exports are regulated by customs, commodity inspection, environmental protection, and other departments. Companies need to ensure all relevant documents and materials are complete before exporting. It is required to handle entry-exit inspection and quarantine to ensure the product meets the quality standards of the destination country.
8. Inspection and Quarantine
Before export, lubricants need to undergo inspection and quarantine to ensure they comply with the relevant standards and regulations of the destination country. This generally includes product quality inspection and packaging inspection.
As a professional personal lubricant OEM/ODM manufacturer, Pingchuang Medical's products have passed ISO13485 system certification, EU CE certification, and successfully passed the US FDA 510(K) certification in 2021, demonstrating their international competitiveness and quality assurance.
