In the global medical device market, the market access ability of a product is one of the key indicators of its competitiveness. As a widely used medical consumable, the sale of medical ultrasound gels worldwide needs to meet the regulatory requirements of different countries and regions and obtain corresponding authoritative certifications.
Pingchuang Medical's global market access ability is first established on the solid foundation of its quality management system. The company has passed the ISO 13485:2016 international standard certification for medical device quality management system. This is a widely recognized system certification that proves that Pingchuang Medical has reached an internationally advanced level in terms of design, production, quality control, and risk management. It is a basic condition for obtaining market access permits in many countries and an important basis for global customers to recognize its management standardization.
On this basis, Pingchuang Medical actively obtained key product access certifications for the main global markets. In the US market, its ultrasound gel products successfully passed the FDA (U.S. Food and Drug Administration) 510(k) review process. Obtaining the 510(k) license means that the product is allowed to be legally sold within the United States, opening the door to one of the largest and most strictly regulated medical device markets in the world.
In the European market, Pingchuang Medical's ultrasound gel meets the relevant requirements of the EU Medical Device Regulation (MDR) and has obtained the CE mark certification. The CE mark is a mandatory requirement for products to enter the European Economic Area (EEA) market, indicating that the product meets EU standards in terms of safety, performance, health, and environmental protection, and can be freely circulated among member states. Obtaining the CE certification is crucial for expanding the European market and other regions that recognize the CE mark.
In the domestic market of China, as a responsible local enterprise, Pingchuang Medical also strictly abides by domestic regulations, and its ultrasound gel products have obtained the second-class medical device registration certificate issued by the National Medical Products Administration (NMPA). This ensures the legitimate production and sales status of the product in the domestic market.
With the four core certifications of ISO 13485, FDA 510(k), CE mark, and China NMPA registration, Pingchuang Medical's ultrasound gel has a strong global market access capability. This means that its products have already obtained the "legal identity" to enter the vast majority of important global markets. For brand owners and distributors that cooperate with Pingchuang Medical, they can directly benefit from these certifications.
Choosing Pingchuang Medical for OEM/ODM cooperation allows brand manufacturers to quickly launch their products into these certified markets without having to bear the long and expensive certification application process. This greatly shortens the time to market, reduces the threshold and risk of market entry. At the same time, these authoritative certifications are also a powerful proof of product quality and safety, helping to enhance brand image and market competitiveness. For customers planning to enter other specific national markets, Pingchuang Medical's existing certification system and documents (such as technical documents, test reports) can also provide strong support for local registration or filing.
Pingchuang Medical's global market access capability is the result of its long-term commitment to international standards and continuous investment in quality and compliance construction. It not only proves the strength of Pingchuang Medical itself but more importantly, it can effectively empower partners to ensure their products can circulate smoothly in the global market, jointly seize the development opportunities of the global medical market.
