Japans Medical Device Evaluation & Approval Process: Submitting the STED (Summary Technical Document (Medical Device Evalu)

Venue: Online

Location: Palo Alto, California, United States

Event Date/Time: Apr 24, 2009
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Description

Understand Japans' medical device approval and evaluation process and what it takes to make it successful. The Japanese MHW requires that all medical products sold in the country be registered. Ensuring that Japanese citizens will have access to the newest technology in medical devices and that devices will be safe and effective are the goals of this agency.

The Japanese expect the manufacturers and importers of medical devices to be socially responsible. MHW, therefore, maintains stringent quality standards for medical products as well as for device manufacturing or importing facilities. Consistent with these MHW regulations, the Japanese government demands that foreign medical manufacturers maintain either a direct or an indirect physical presence in Japan to ensure an immediate response to safety problems related to the use of a medical device.

A medical device manufacturer, whether domestic or foreign, must first obtain two types of consent from MHW: a kyoka (license) and a shonin (approval). A kyoka provides the medical device manufacturer or distributor with authorization to market its products in Japan.

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Additional Information

Understand Japans' medical device approval and evaluation process and what it takes to make it successful. The Japanese MHW requires that all medical products sold in the country be registered. Ensuring that Japanese citizens will have access to the newest technology in medical devices and that devices will be safe and effective are the goals of this agency. The Japanese expect the manufacturers and importers of medical devices to be socially responsible. MHW, therefore, maintains stringent quality standards for medical products as well as for device manufacturing or importing facilities. Consistent with these MHW regulations, the Japanese government demands that foreign medical manufacturers maintain either a direct or an indirect physical presence in Japan to ensure an immediate response to safety problems related to the use of a medical device. A medical device manufacturer, whether domestic or foreign, must first obtain two types of consent from MHW: a kyoka (license) and a shonin (approval). A kyoka provides the medical device manufacturer or distributor with authorization to market its products in Japan.