medical devices registration in China
Freyr Solutions China specializes in regulatory consulting and compliance solutions for medical devices, IVDs, and digital health products. Its services include device registration, market access support, regulatory affairs consulting, technical documentation, clinical evaluation, performance evaluation, quality management system implementation, post-market surveillance, and regulatory intelligence. The company also provides support for Software as a Medical Device (SaMD), helping manufacturers navigate evolving regulatory requirements and achieve compliance in China and international markets. With expertise spanning more than 120 countries, Freyr enables organizations to streamline regulatory processes, reduce compliance risks, and bring safe, effective medical devices to market faster.