Pushing medical ultrasound gels into the global market means that products must cross the regulatory thresholds of different countries and regions. The strict review of the US FDA, the complex requirements of the EU MDR, the registration process of the Chinese NMPA, and the various entry regulations of other countries constitute major challenges for the globalization of medical devices.
Brand manufacturers need a partner who deeply understands and can provide ultrasound gel solutions that meet the major medical regulations of the world. Pingchuang Medical Group, with its comprehensive international certifications, professional regulatory teams, and global production standards, is committed to providing such solutions to help customers' products smoothly enter the global market.
The core of meeting global medical regulations lies in establishing a high-standard foundation platform that can meet the requirements of multiple countries. Pingchuang Medical's platform is built on the ISO 13485 medical device quality management system and strictly follows GMP production specifications. ISO 13485 is an internationally recognized medical device industry standard that is directly related or highly compatible with the regulatory requirements of many countries (such as the EU MDR, Canada CMDCAS, etc.). GMP represents high requirements for the规范性 of the production process. This solid foundation platform enables Pingchuang Medical's production system to inherently have the potential to meet the basic regulatory requirements of the majority of global markets.
On this basis, Pingchuang Medical actively obtained access permits for key markets. Its ultrasound gel products have obtained the US FDA 510(k) certification and the EU CE mark. The FDA 510(k) certification proves that the product meets the safety and effectiveness requirements of the US market, while the CE mark indicates that the product complies with the relevant directives or regulations of the European Economic Area. At the same time, the product also holds the Chinese Class II medical device registration certificate. This series of authoritative certifications covers several of the most important medical device markets in the world, providing customers with compliant product options for direct entry into these markets.
The solutions provided by Pingchuang Medical are not limited to certified products. For customers who wish to enter other countries or regions (such as Australia TGA, Brazil ANVISA, Japan PMDA, etc.), Pingchuang Medical's professional regulatory team can provide support. They are familiar with or can quickly research the specific regulatory requirements of the target market, assess the gaps between existing products or systems and these requirements, and assist customers in preparing the necessary registration/filed documents (such as using existing ISO 13485 certificates, CE/FDA certificates, biocompatibility reports, technical documents, etc. as supporting materials) to simplify and accelerate the local access process as much as possible.
The solution is also reflected in the global adaptability of the product itself. When developing formulas and selecting raw materials, Pingchuang Medical considers the general requirements of global regulations, such as prioritizing the use of ingredients that are widely accepted and have a good safety record in multiple major markets, avoiding the use of substances that are banned or strictly restricted in certain regions. In the design of labels and instructions, adjustments can also be made according to the language and regulatory requirements of the target market. Multiple packaging options that meet international transportation standards are provided.
The global consistency of the production process is also part of the solution. Regardless of where the product is ultimately sold, Pingchuang Medical adheres to the production and quality control in a 100,000-class clean room, using medical-grade raw materials, and following the same GMP and ISO 13485 standards. This means that customers can be confident that regardless of their target market, they will receive the same high-quality, safe, and reliable products.
