Is this a medical device?
Updated: July 2024, 3
At the end of your neck, is it a medical device?
[Inspection of current use, treatment or protection of human or animal diseases, effects of human or animal diseases, physical structures or functional machinery, equipment, etc. (excluding regenerative medical equipment, etc.), articles specified by government laws and regulations].
Among them, medical equipment for commercial use is designated as medical equipment for commercial use. The Ministry of Agriculture, Forestry and Water Industries (MAFF) is responsible for handling medical equipment and equipment.
Medical equipment classification
Based on the basic level of animal life and health hazards (wind), three categories of medical equipment.
| Category | definition | An example | How to register medical equipment |
| General medical equipment (low to low wind) | Excluding highly managed medical equipment and externally managed medical equipment, and other medical equipment, however, under circumstances where the current side effects or performance of the medical equipment is limited, the current impact of life and health may be small or lost. | Medical sterilizers, testers, thermometers | The report was immediately completed and accepted by the Director's Office. |
| management medical equipment (Medium to low wind) | In addition to medical equipment that is highly susceptible to exclusion, medical equipment that can be managed due to its side effects or functions and that can be seriously affected by life, health, and needs. | Medication machine, respiratory aid, internal organ function replacement product | After the submission of the report to the Director's Office, the system will be processed for about three months, and the distribution will be completed. |
| Highly managed medical equipment (Moderate, high wind and high wind) | Causes, side effects, or performance damage (as long as proper use is assumed), and when possible, the animal's life and health can be created, and it can have a heavy influence and be managed according to demand. | Closed circulation hemp system, closed circulation cultivation box | After the submission of the report to the Department of Inquiry, the system will be processed for about 6 months, and the distribution will be completed. |
Approval of approval for medical equipment classification, etc.
If you are in the market for medical equipment, you can get a different category of medical equipment based on the demand.
Please see below for the types of items for production, manufacturing, and production/tax sales.
| grade classification | Item type | manufacturing | production Japanese music industry | Music and tax sales |
|---|---|---|---|---|
| General medicine equipment | Record | Register | 3rd category medical equipment production Japanese version available | - |
| management medical equipment | Authorization | The second category of medical equipment production is available for purchase. | Record | |
| Highly managed medical equipment | Authorization | First category medical equipment production | license |
Medical equipment for medical use is available for admission.
Support administrative register corporations for newly introduced medical equipment business enterprises, current manufacturers, production commerce, and Japanese machinery commerce.
As we apply for advanced industrialization of medical equipment, this report covers a number of regional administrative agencies.
We provide medical equipment, legal services, and legal services based on our work, administrative agents, and representative companies.
I am an employee of the prefectures in Japan who own the prefectural government.
If you would like more information, please contact us. We all have high expectations for this collaboration!
