For Chinese medical device brands or enterprises intending to enter the medical field, the vast international market is full of opportunities. As a basic and high-consumption medical consumable, medical ultrasound gel is one of the ideal entry points for exploring the international market.
However, the international market means different regulatory barriers, market environments, and cultural backgrounds. Choosing a partner with rich international OEM experience can provide valuable navigation and support for the brand's "export" journey. With its experience serving 76 countries and regions around the world and its manufacturing capabilities that meet international standards, Pingchuang Medical Group can effectively help you explore the international medical market.
Rich international market experience is first reflected in compliance with major global regulations. Pingchuang Medical's ultrasound gel products and production systems not only meet China's second-class medical device requirements but also have obtained the access certifications of the US FDA 510(k) and the EU CE in the two major international mainstream markets, and are in line with the ISO 13485 medical device quality management system standard. This means that its products inherently have the basis to enter key markets such as North America and Europe. Choosing Pingchuang Medical for OEM cooperation allows the brand to directly utilize these existing qualifications, significantly shortening the time to enter the target market and reducing compliance risks.
Experience is also reflected in understanding the specific requirements of different national markets. In addition to FDA and CE, many countries have their own unique registration, filing, or import requirements. During the long-term service to global customers, Pingchuang Medical's international business team and regulatory team have accumulated experience in handling market access affairs in different countries. They understand the subtle differences in product labeling language, instruction manual content, packaging specifications, and even color preferences in different regions, and can take these factors into consideration in the product design and production stage, avoiding unnecessary troubles later on.
Thirdly, experience is reflected in mature international logistics and trade operation capabilities. Delivering products from Chinese factories safely, on time, and in compliance to the hands of overseas customers involves complex logistics, customs declaration, and customs clearance procedures. Pingchuang Medical has an experienced logistics coordination team and has established cooperative relationships with several international freight forwarders, familiar with the operation processes of different transportation methods such as sea and air transport. They can assist customers in handling export documents, arranging transportation, and dealing with possible emergencies, ensuring smooth delivery of goods.
Fourth, the communication and collaboration experience with international clients. Effective communication with clients from different cultural backgrounds and using different languages is the key to the success of international business. Pingchuang Medical is equipped with professionals who are proficient in using foreign languages such as English for communication, able to accurately understand customer needs and provide clear information feedback. Its standardized project management processes and customer-centric service philosophy are also applicable to international cooperation, ensuring the smooth and efficient process of cooperation.
Fifth, the manufacturing capability that meets international standards is the material basis of experience. Pingchuang Medical's ten-thousand-level clean room, GMP production specifications, selection of medical-grade raw materials, and strict quality control system ensure that its produced ultrasound gel can consistently meet the high-quality standards required by international customers. Regardless of where the order is shipped, the product quality can maintain consistency and reliability.
