I don’t know exactly whether the aforesaid product fall under the category of medical devices or cosmetics in Japan Medical devices regulations. But, I would like to update the recent
FDA’s advisory notice warning of possible effects the ongoing nuclear disaster in Japan may have on medical device components exported to the US. (this may not relevant to OP’s question but just a heads up) , The notice expresses concern that possibly deteriorating manufacturing conditions in areas most affected by the tsunami, earthquake and nuclear plant meltdown could compromise safety and effectiveness of devices for export to the US market.
The FDA’s specific concerns include
radioactive contamination of device components, especially those derived from animal materials; contaminated water supplies causing device defects, less reliable availability of electrical power disrupting manufacturing processes, compromised sterilization procedures needed for some devices, compromised reliability of product performance, particularly for components such as electrical connectors, microprocessors and sensors, and damaged manufacturing facilities causing supply shortages of components and finished devices.
Additional precautions are also recommended for certification of electronic products and components, including:
• Assessment of incoming devices and supplies to ensure conformity to specifications and quality requirements
• Monitoring of purchasing and acceptance procedures such as inspections and sampling to ensure device and component integrity
• Inspection of device power supplies for water damage
• Running quality control checks to verify product safety
• More thorough assessment of animal-derived products and components such as raw heparin
To access the complete list of FDA’s CDRH recommendations please refer below link
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm257527.htm
S.Subramaniam