Approval or confirmation of minor changes
Updated: July 2024, 3
We will assist you in obtaining medical equipment manufacturing costs, approval or approval of the product, and provide support for any minor changes or modifications.
Our own resources and industry knowledge for our general operations, as well as our own internal resources, support and support for our customers.
As a result of the manufacturing of the medical equipment, please acknowledge or confirm the change in the changes and the difficulty, and when you follow me, you will be advised to proceed with the system.
Approval of the progress of the demand or approval of the change of plan
Nezu, July 29, 7, 误生机审叡发31No. 0731《关于medical equipment partial change request procedure for minor change changes, etc.》, hereinafter referred to as the information demand proceeding partial change approval (simply referred to as ``one change'').
| ① | Increasing the quality of high-quality products, changing the existing technology or the new technology in terms of effectiveness or safety, and having a positive impact on creating people's lives and health. |
| ② | It is estimated that the quality of the product is safe, effective, safe, and has no impact on the human life and health. |
| ③ | Immediately, the product's shape and structure change, but the product's identity remains unchanged. (This is a small change, but it is a change in shape, a change in shape, a major change in the structure, a change in the method of use, etc.) |
| 4 | ① to ③ Three types of circumstances, including the Conflict Medical Products, Medical Instruments, etc. Act, the Alcohol and Alcohol Products Control Act, the Toxic and Harmful Substances Control Act, etc. The person who has lived for the last 20 years |
| ⑤ | An adult who consumes alcoholic beverages, cannabis, or alcoholic beverages. |
| ⑥ | According to the Ordinance of the Ministry of Health, Labor and Welfare, persons with physical and mental disabilities are eligible for the use of highly managed medical equipment or specific insurance managed medical equipment, or who are responsible for tax liability. |
In addition to the above-mentioned changes, other information may be added to the changes.
While the same notice was being issued, this is an example of a proposed change.
关于轻经认认范围
1. Shape, structure and principle
| ① | |
| ② | Changes in the names of medical equipment, etc. for combined use |
| ③ | Changes in quality, effectiveness, safety, production, size, size, etc., of the quality of the product, as well as minor changes in product parts. |
| 4 | Additional changes in the purpose of use and method of use may be made in conjunction with other medical equipment, production, or additional changes in the use of medical equipment. However, the ownership conditions (1) to (4) below the demand. (1) The purpose of use and the medical equipment currently used are the same. (2) The purpose and method of use of the product shall not change. (3) Common names for the currently used combination of medical equipment and the additional combination of medical equipment used. (4) Current demand combination usage situation, previous combination example, no demand progressing new example. |
| ⑤ | Product quality, effectiveness, safety, production impact, minor component parts, attachments or combinations of medical equipment used. |
| ⑥ | other expressions |
2. Performance and safety specifications
| ① | Under the circumstances of comparative examination of the existing product and the existing product, there will be no change in the actual design and medical equipment. |
| ② | Product quality, effectiveness, safety, production impact, and minor changes in product quality. |
3. Others
| ① | Approval of unchanged changes |
If you want to change the location of the event in advance, please check the changes according to the category you belong to.
Shape, structure and principle
| ① | It is possible to change the dimensions of each part in terms of quality, effectiveness, safety, production, and impact. |
| ② | Similar products are available in the current orthopedic implant equipment products, with changes or additions in shape. |
| ③ | Possible product quality, effectiveness, safety, production benefits, usage pattern changes, etc. |
| 4 | Others |
Performance and safety specifications
| ① | Possible additions or changes to the quality of the product, effectiveness, safety, production, performance, etc. |
| ② | Changes in examination conditions, descriptive exclusions, etc. |
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 application has high level of industry, ability is perfect, and administrative staff is small.
Our teams are present in all prefectures across the country. You must receive additional information from our system.
