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Practical Experience Exporting to 76 Countries! Key Points for Compliant Custom Personal Lubricant Foreign Trade.

Jul. 11, 2025

Taking personal lubricants to the international market is an important strategy for many enterprises to expand their territory and enhance brand value. However, the regulatory barriers, market access standards, and cultural differences in various countries and regions place extremely high demands on foreign trade compliance. Without adequate preparation and professional knowledge, it's easy to encounter setbacks during export.


Practical Experience Exporting to 76 Countries! Key Points for Compliant Custom Personal Lubricant Foreign Trade.

 

Pingchuang Medical has practical experience exporting to 76 countries and regions worldwide, which is crucial for guiding brand owners to successfully "go global." Here are some core foreign trade compliance points.

 

First is legal and regulatory certification in the target market. Developed country markets like Europe, America, and Japan have particularly strict regulations for personal lubricants. For example, exporting to the US market may require FDA (Food and Drug Administration) registration or 510(k) approval; selling to EU countries requires compliance with CE certification-related directives, such as the Medical Device Regulation (MDR) or Cosmetics Regulation; Japan also has its independent Pharmaceutical and Medical Device Act (PMD Act). These certifications not only concern the safety of product ingredients but also involve the standardization of production processes, accuracy of labeling, etc.


Practical Experience Exporting to 76 Countries! Key Points for Compliant Custom Personal Lubricant Foreign Trade.

 

A comprehensive quality management system is a fundamental guarantee. The ISO 13485 medical device quality management system certification is an internationally recognized standard. It requires enterprises to establish strict quality control processes throughout the entire cycle, from R&D design, raw material procurement, production control, product inspection to after-sales service. Possessing this system certification means the factory has the capability to continuously and stably produce compliant products, serving as a "pass" to obtain international orders.

 

Preparation and management of product technical documentation should not be underestimated. Whether applying for various international certifications or dealing with customs inspections and customer audits, a complete, professional, and accurate set of product technical documents (including formulation sheets, process flows, inspection reports, risk assessments, stability data, etc.) is essential. The quality of these documents directly affects whether the product can smoothly clear customs and be launched.

 

Protection of intellectual property and risk avoidance are equally critical.

 

Pingchuang Medical, with its rich practical experience exporting to 76 countries and regions worldwide, as well as complete global compliance certifications like FDA 510K, EU CE, and ISO 13485, can provide your brand with one-stop services from regulatory consulting and certification support to custom production.


Practical Experience Exporting to 76 Countries! Key Points for Compliant Custom Personal Lubricant Foreign Trade.