Definition of medical device
Updated: July 2024, 9
What is medical equipment?
This is how it is defined in the Pharmaceuticals and Medical Devices Act.
Mechanical devices, etc. (excluding regenerative medicine products) that are intended to be used for the diagnosis, treatment, or prevention of human or animal diseases, or to affect the structure or function of the human or animal body. and those specified by Cabinet Order.
Some people think that just because it is a health or beauty device, it is not a medical device, but even if it is labeled as a health or beauty device, if it falls under the above definition in light of its purpose of use, structure, effect, etc. , may fall under "medical equipment."
Classification of medical devices
Medical devices are classified into classes according to the degree of risk they pose to the human body.
The degree of danger to the human body increases in the order of general medical devices < controlled medical devices > highly controlled medical devices.
The registration method for medical devices and the type of manufacturing and sales license that should be acquired vary.
| Category | Definition | An example | Medical device registration method |
| Class I General medical equipment | Even if a problem occurs, the risk to the human body is extremely low. | Glasses, scalpel, tweezers, bandage, stethoscope | Registration is completed by submitting a notification to PMDA, and the notification is accepted on the same day. |
| Class II managed medical equipment | Items that pose a relatively low risk to the human body even if a malfunction occurs | Blood pressure monitor, magnetic therapy device, MRI, massage device | Apply to a private certification body, and a number will be assigned after passing through the certification body for about 3 months. |
| Class III Highly managed medical equipment | Items that pose a relatively high risk to the human body if a malfunction occurs | Contact lenses, colored contact lenses, dialysis machines, implants | Apply to PMDA and receive a number after going through an examination body for 6 months to 1 year or more. |
| Class IV Highly managed medical equipment | Items that are highly invasive to the human body and can directly lead to a life-threatening situation if a malfunction occurs. | pacemaker stent | Apply to PMDA and receive a number after going through an examination body for over a year. |
Necessary permits, etc. according to the classification of medical devices
In order to distribute medical devices on the market, permits and licenses are required according to the classification of the medical device.
The types of item applications corresponding to the classes, manufacturing industry, manufacturing and sales industry, sales/leasing industry, and repair industry are as follows.
| Classes | Item application type | Manufacturing industry | Manufacturing and sales business | Sales/lending business | Repair business |
| I | notification | Registration (no classification) | Type 3 manufacturing and sales license | - | Permit (by category) |
| Ⅱ | Authentication | Type 2 manufacturing and sales license | notification | ||
| Ⅲ | Approval or Certification (highly managed medical devices with established standards) | First class manufacturing and sales license | Authorization | ||
| Ⅳ | Authorization |
For consultation regarding permits and licenses regarding medical devices, please contact Support Administrative Scrivener Corporation.
At Support Administrative Scrivener Corporation, we provide application support and consulting regarding the Pharmaceutical and Medical Device Act, from those newly entering the medical device industry to existing marketing distributors, manufacturers, and distributors.
Applications for medical devices are highly specialized and can be said to be one of the fields in which there are few administrative scriveners who can handle them.
We provide legal services related to medical devices based on the know-how and track record that we can accumulate because we are administrative scriveners who handle applications and negotiations with administrative agencies on behalf of companies on a daily basis.
Our staff has a track record of applying in all prefectures across the country. Please contact us by all means.
Our dedicated staff handles cases nationwide.
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