Under China's medical device regulatory system, medical ultrasound gel belongs to Class II medical devices and must hold a registration certificate issued by the National Medical Products Administration to be legally produced and sold. At the same time, if the product aims to explore overseas markets, it also needs international certifications like FDA and CE. A manufacturer holding both domestic registration certificates and international certifications is a quality supplier truly possessing internal and external strength.
Products from such a manufacturer with complete dual certificates have passed the verification of both domestic and international standards, with greater assurance of safety and effectiveness. For agents or brand owners serving both the domestic market and considering future exports, cooperating with such a manufacturer can perfectly achieve synchronous layout of product lines domestically and internationally, avoiding the costs of repeated R&D and certification, and realizing efficient resource utilization.
Pingchuan Medical is one of the few professional gel manufacturers in China that combines a Class II Medical Device Registration Certificate, ISO13485, US FDA 510(k), and EU CE certification. Relying on comprehensive qualifications and dedication to quality, we provide a full-chain service from conventional supply to OEM/ODM customization. Choosing Pingchuan means choosing a steady development path of domestic compliance and international recognition.
