medical equipment definition
Updated: July 2024, 3
Medical equipment is the same.
Medical products, medical equipment, etc. are defined as Chinese medical equipment and equipment.
Examination of the existing use of government ordinances, treatment of human or animal diseases, or machinery equipment that affects the physical structure or functional life of people or animals (inclusive regenerative medical equipment).
Naturally, the product is "health equipment" or "beauty equipment", but it is not a medical equipment, but the name used is "health equipment" or "beauty equipment", the purpose of use, the overall effect, etc. are the same as defined above, but it is possible to belong to "medical equipment". .
medical equipment classification
The extent of the dangers to the human body, etc., and the advancement of medical equipment.
The progress of general medical equipment and controlled medical equipment has been increased, and the degree of danger to the human body in medical equipment has gradually increased.
Medical equipment supply method, demand acquisition, manufacturing and sales industry, different types and locations.
类别 | definition | example | Medical equipment injection method |
Ⅰ category General medicine equipment | Immediate delivery problem, the medical equipment with very low human body style | Eyeglasses, hand swords, pincers, armor, instruments | PMDA plan completed and accepted for immediate employment |
Class II management medical equipment | Immediate delivery problem, first human body style medical equipment with low performance | Blood meter, magnet, MRI, massage device | After submitting the application for certification to the public, it took 3 months to complete the application. |
III category Highly managed medical equipment | At the time of appearance, medical equipment with high human body style | Eyeglasses, colored eyeglasses, dialysis machine, implantation equipment | After submission of the PMDA application, it has been 6 months to 1 year since then. |
Ⅳ Category Highly managed medical equipment | Highly invasive, potentially life-threatening medical equipment | Shinshu-kiki, support | Submitted by PMDA, after more than 1 year, scheduled to be submitted |
Approval for obtaining the classification of medical equipment, etc.
Once the medical equipment is introduced into the market, the demand for the medical equipment is determined by its own category, and the approval for acquisition is permitted.
Separate foundation categories, complementary item categories, mutual manufacturing industry, manufacturing sales industry, purchase industry or purchasing industry, repair industry as shown below.
| 类别 | Item application type | manufacturing | manufacturing sales | sales or sales | Repair business |
| Ⅰ category | Record | Notes (not categorized) | 3rd category manufacturing sales allowed | - | Allowed (obtained for each category separately) |
| Class II | Certification | 2rd category manufacturing sales allowed | Record | ||
| III category | Acknowledge or Certification (certified highly controlled medical equipment) | 1rd category manufacturing sales allowed | license | ||
| Ⅳ Category | license |
Licensed medical equipment, approval, approval, etc. are compatible with each other, and we are familiar with the system.
We support and submit legal claims for newly introduced medical equipment businesses, existing manufacturing businesses, production businesses, Japanese machinery businesses, etc.
Medical equipment has a high level of industry, and its capabilities are perfect, as well as small administrative staff.
However, we provide medical equipment, medical equipment, legal services, and other legal services based on the basis of our production, business, and business agents.
Our teams are present in all prefectures across the country. You must receive additional information from our system.
