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posted by fanblog
2023年08月30日
Kangen-8 Medical Device Certification......What to know
Enagic is well known as a manufacturer of continuous electrolytic water generators.
In particular, the product called "LeveLuk Kangen-8" is certified as a medical device.
So what does this accreditation mean and what criteria is it based on?
First, as a basic point, "medical device certification" and "medical device marketing authorization" are two different concepts.
Medical Device Certification
It means that the product meets specific medical and safety standards.
Medical Device Marketing Authorization
It is a sign that the entire company is recognized as meeting certain quality and safety standards in the manufacturing and marketing process.
The LeveLuk Kangen-8 is certified as a medical device, which means that the product itself meets high standards.
Since Enagic is licensed to manufacture and sell medical devices, it can be assumed that a certain level of quality is ensured for the company's other products.
In order for a medical device to be certified, it must meet the following criteria
Safety
Electrical, mechanical, and biological safety will be considered.
Proof of Effectiveness
The product must be scientifically proven to be effective.
Quality Assurance
Appropriate quality control must be in place during the manufacturing process.
Proper labeling and documentation
Instructions for use and warnings are adequately provided.
Compliance
Compliance with national and local regulations, e.g., ISO and FDA standards.
In Japan, medical devices are regulated by the Ministry of Health, Labor and Welfare (MHLW).
The Ministry of Health, Labor and Welfare evaluates the safety and effectiveness of the product,
Permit sales on the market if they meet the required criteria.
The fact that Enagic's Leveluk Kangen-8 is certified as a medical device indicates that the product may meet certain high standards.
Certified medical devices are generally safe for patient health and their effectiveness has been scientifically proven.
This is a reliable indicator for consumers.
However, the effectiveness and safety of specific products vary from one individual to another,
It is also important to have sufficient information and an impartial expert opinion.
In particular, the product called "LeveLuk Kangen-8" is certified as a medical device.
So what does this accreditation mean and what criteria is it based on?
●Approval of medical devices and manufacturing and marketing authorization
First, as a basic point, "medical device certification" and "medical device marketing authorization" are two different concepts.
Medical Device Certification
It means that the product meets specific medical and safety standards.
Medical Device Marketing Authorization
It is a sign that the entire company is recognized as meeting certain quality and safety standards in the manufacturing and marketing process.
The LeveLuk Kangen-8 is certified as a medical device, which means that the product itself meets high standards.
Since Enagic is licensed to manufacture and sell medical devices, it can be assumed that a certain level of quality is ensured for the company's other products.
●Certification Criteria for Medical Devices
In order for a medical device to be certified, it must meet the following criteria
Safety
Electrical, mechanical, and biological safety will be considered.
Proof of Effectiveness
The product must be scientifically proven to be effective.
Quality Assurance
Appropriate quality control must be in place during the manufacturing process.
Proper labeling and documentation
Instructions for use and warnings are adequately provided.
Compliance
Compliance with national and local regulations, e.g., ISO and FDA standards.
●Japanese regulators
In Japan, medical devices are regulated by the Ministry of Health, Labor and Welfare (MHLW).
The Ministry of Health, Labor and Welfare evaluates the safety and effectiveness of the product,
Permit sales on the market if they meet the required criteria.
●Summary
The fact that Enagic's Leveluk Kangen-8 is certified as a medical device indicates that the product may meet certain high standards.
Certified medical devices are generally safe for patient health and their effectiveness has been scientifically proven.
This is a reliable indicator for consumers.
However, the effectiveness and safety of specific products vary from one individual to another,
It is also important to have sufficient information and an impartial expert opinion.
