Technologies developed and manufactured by CME
CME is the catalyst for effective medical-engineering collaboration. Medical and engineering professionals at universities and other educational research institutions, work synergistically with private-sector counterparts to research and develop new technologies and create new businesses in the medical field, with CME mediating the interplay and collaboration process.
Medical schools and institutions, among many others who depend on medical devices, constantly seek new treatment modalities or improvements on existing therapies. Meanwhile, on the engineering side, each science and engineering department and manufacturing firm has unique technology and know-how which could make that happen. In short, the medical field has the needs, and the engineering field has the seeds.
Unfortunately, Japan hasn’t developed the ecosystem for the symbiotic relationship between the two to take shape naturally.
International players face particularly daunting challenges in the Japanese system. Government policy focuses on supporting domestic medical device production, and cultivating the export market for these domestic players. However, in the opposite direction, international firms entering the Japanese medical field must deal with numerous obstacles, starting with the difficulty they face in trying to obtain business licenses. We serve to support companies who might otherwise hesitate to enter Japan’s medical market, by confidently guiding them past potential regulatory hurdles and other bumps in the road.
As a licensed Marketing Authorization Holder (MHA), CME can bring medical devices from concept to market. In this capacity, CME designs and develops the product, applies for regulatory approval, and also handles mass production and sales to medical device vendors.
CME designs, develops and applies for regulatory approval of the medical device, in its capacity as a licensed MHA. Actual mass production is consigned to another manufacturer, but CME remains in charge of sales to medical device vendors.
A medical device vendor or distributor engages CME to develop a product idea and manufacture the product. CME then designs and develops the medical device based on the client’s requirements. In its MHA capacity, CME applies for regulatory approval, and undertakes mass production. The finished product is sold exclusively to the medical device distributor or vender who commissioned it.
A medical device manufacturer and distributor engages CME to develop and manufacture the product. CME designs, develops and produces the medical device to client specification. The client files for regulatory approval, while CME (acting as medical device MAH) supplies the finished product on an OEM basis.
CME is designated marketing authorization holder (DMAH) by an overseas medical device manufacturer, allowing CME to import the manufacturer’s device. CME also serves as the representative service for regulatory matters in Japan.