We provide manufacturing and sales certification services for specified managed medical devices.
Medical device regulatory affairs.
We provide manufacturing and sales certification services for specified managed medical devices.
Our company received registration as a certification body from the Minister of Health, Labour and Welfare on April 1, 2005 (Registration Number: AG No.), and we have started providing certification services for the manufacturing and sales of designated management medical devices. We are capable of certifying all designated management medical devices except for in vitro diagnostic drugs.
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basic information
The revised Pharmaceutical Affairs Law came into effect on April 1, 2005. Under this law, manufacturers and sellers of Class II medical devices (designated management medical devices) specified by the Minister of Health, Labour and Welfare must obtain certification from a registered certification body for each individual item prior to market launch. (Pharmaceutical Affairs Law Article 23-2, Paragraph 1)
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Applications/Examples of results
Active implantable devices, anesthesia and respiratory devices, dental devices, medical electrical equipment, facility equipment, non-active implantable devices, ophthalmic and visual devices, reusable devices, single-use devices, home massage devices, home electrical therapy devices and their related equipment, hearing aids, radiation and imaging diagnostic equipment, etc. *For other inquiries, please contact us.
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Company information
You can outsource tasks such as medical device certification, radio law certification, terminal equipment certification, electrical appliance safety law, consumer equipment EMC testing, automotive equipment EMC testing, product safety testing, overseas application agency, and domestic application agency. There are four testing facilities, including one in Matsusaka City, Mie Prefecture. If you have any questions about testing content or testing locations, please feel free to contact us.
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