Medical Device or Cosmetic Device in Japan? Hand Held Wrinkle Reduction LED Light

S

Slaterson22

#1
I have a hand-held LED light for the reduction and elimination of fine lines and wrinkles. It creates collagen and plumps the skin up and pushes out the wrinkles. Under the FDA, I have a medical device. Does anyone know if this is a medical device in Japan, or would it be more for cosmetic purposes? I am having a hard time finding the definition for a medical device in Japan, but I do not think that wrinkles are a medical condition in Japan. But, it alters structures or functions of the bodies. It does build collagen and stimulate cells in the dermis layer. Any help would be deeply appreciated. Thanks!
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Hi,

As a rule of thumb, you can expect similar or stricter policies in Japan medical device regulation, comparing to the FDA :(

Cheers,
Ronen.
 

bio_subbu

Super Moderator
#3
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
 
R

Reiko Shiratori

#4
Hi Slaterson22,

I think your product is a medical device in Japan too.

According to the PAL (Chapter 1, Article 2), "Medical devices" refers to those equipments/instruments which are intended for use in the diagnosis, treatment or prevention of disease in humans or animals, or intended to affect the structure and functions of the human or animal body.

I hope this helps.

Reiko:bigwave:
 
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