Partial change request for approval or approval

Increasing the quality of high-quality products, changing the existing technology or the new technology in terms of effectiveness or safety, and not having any impact on the creation of people's lives and health.

It is estimated that the quality of the product is safe, effective, safe, and has no impact on the human life and health.

The product's shape or structure has been completely changed, but the product's identity has not been damaged. (Naturally, the change is small, but it is contrary to the sameness of the product, the shape is changed, the product is changed, the method of use etc. is changed, etc.)

●If the name of the purchase is changed, the request for approval of the change of the demand-proceeding part will be submitted. Due to the demand, due to additional circumstances, demand for production and other items will be submitted.

- Under the current circumstances, due to force majeure such as the current commercial order, we will notify you of the current situation, and we may be able to make minor changes to the order.

Change in purpose of use of influence?

●Consideration of demand, whether or not to change the purpose of use (category of use in general, peripheral use to central use, etc.), production effects, and limitations on the intended use, effects, etc.

●For example, the use of diffused light in existing eyeglasses may change.

Any changes to warnings, contraindications or precautions?

● Warnings, contraindications, and precautions are usually not included in the section, so please note that this is not required, but please review the PMDA Safety Department.

Is there a change in how the user operates or how to use it?

Please understand that you understand the basic operation method, but please understand that you can add the following information to the "How to use" in the manual. Internal document management.

●Intrusive sexual use of the device may be changed, but clearly the method of use may be changed, under any circumstances, and not subject to change.

Is it possible for the meeting to have an effect, be effective, and be safe?

●If the effect is effective and the safety is not affected, there is no effect on the situation, there is no demand for progress, but it is a case of notification during notification, and there are some changes in demand.

●Examples of possible invasiveness, safety effects, and potential effects of changes in usage. In addition to this, the addition of additional features to the shape of the mirror, its effectiveness and safety, as well as its effects.

●Please note that the information contained in this document was not specified, and the information regarding the combination of medical equipment and equipment under the circumstances of the new equipment was examined. In addition, there may be a change in the identification, a change in the accompanying text, a change in the name of the product, etc., a change in the name of the product, etc., due to the fact that there is no effect on the effectiveness and safety of the product, and there is no effect on the performance of this request. Handwritten.

●Is it right or wrong? Is there a change in the operating model or operating mechanism (principle) of the existing equipment? Is there a change in the working principle that has a large influence on the mechanical ability? In addition to this, there are changes in the mechanical control system when considering the demand, such as changes in the control system of the electric machine and the mechanical control system.

●For example, the difference in the fixed flow and the dynamic flow in terms of artificial new creation, the difference in the internal view light source, the change in the direct light method that leads to the light source, etc.

Change for the purpose of using the effect?

●Review of "Intended Use, Functionality and Effects" during the limited review, review of changes, and intended use (classification of use for comprehensive eyeglasses, middle-sized eyeglasses, peripheral use to central use, etc.)?

●For example, there are various types of changes in the shape of the eyeglasses, such as the use of diffused light.

Warnings, contraindications or precautions?

●Warnings/Contraindications and Precautions are usually not included in this page, but please note that this is not required in the PMDA safety section.

Changes in the renewal dynamic category?

● Changes in mechanical power sources or types of mechanical power output. For example, when an alternating current electric current changes to an internal electric source, and when the current energy is absorbed into the body, an electric current changes from a radiating line to an ultrasonic wave.

Change in performance or scale?

●Details on the equipment's intended performance or function will change when the equipment is developed. Significant changes in the comprehensive equipment usage environment, etc.

For example, additional functionalities in medical electrical equipment, increased curvature strength of artificial tubes, increased strength of high tube tubes, increased ability to withstand pressure of tubes, improved cleanliness of dialysis machines, The characteristics of high MRI resistance may vary.

Ergonomic changes at the patient/user interface?

●Is there a change in the interface between the patient and the user?

●For example, various types of warning sounds, light alarms, control panel distribution, face-to-face information presentation methods, etc.

Change in size/shape?

●Mechanical physical size or shape change? Dimensions include mechanical length, width, thickness or diameter, and the location of equipment and components.

Is there any change in the effective period of approval?

●If the product is fixed, the effective time limit will not exceed 3 years, the time limit for approval or confirmation during installation, the time limit for extending the length of time, the answer is "Yes".关于对于于轻轻变备认的情形、demand reference 药食机发 No. 0905001 (September 20, 9) progress reference.

Change in germ-free packaging?

●As stated in appendix 1023001 of the Food Machine No. 20 (October 10, 23), there are changes in the packaging materials, thickness, and shape of the packaging materials that are guaranteed in the packaging.

Is it true or not? Is it safe to proceed with the test?

●When the new design is safe and effective, we will ensure its validity and the validity of the new design, as well as the lack of sufficient number of tests, and the minimal demand for approval of changes in the running part. For example, if the implantation method has a high degree of innovative treatment ability, etc., the answer is "Yes". If there is a need or a lack of demand, there should be an examination of the machine structure.

What is the quality of the product, the effectiveness and the safety of the product?

●Details on whether or not there are any changes to the provisions of Article 47 of this article.

●For example, if you change the wind and change the wind, the result will be expressed, the appearance of the new wind will be increased, and the change will be changed.

●This is an example of a change in the effects of non-meeting production. Except for this, appendix 1023001 of the Eishoku Mekou No. 20 (dated October 10, 23) has been provided.

●In the situation regarding product quality, effectiveness and safety, there are two examples of attachments to the article No. 1023001 (dated October 20, 10), and the situation regarding the unnecessary manual. .

●Confirmation of the purpose of changing raw materials, reasons, the characteristics of changing performance or convenience of functional raw materials, the content of changes based on demand, the content of changes to be made as a result of ongoing changes, approval requests for partial changes, etc. Handbook, reference table B progress judgment.

●Each type of raw material should be monitored separately, depending on the material's purpose.

Is it a change to biologically derived raw materials?

●Procedure for requesting approval for changes in raw materials such as designated biological products such as vital ingredients, urine concentration, or cell organization. However, this excludes information such as notices, etc., which may be used for minor changes.

Is there a change in raw materials?

●“Raw material type change” means a general name or common name for a progressive change in quality. For example, a name that appears clearly in the first page and after use.

●Under the circumstances of the change in the type of raw materials, changes in the supply of raw materials, changes in additions, etc., the details of the specific content in the approval book based on demand.

●In terms of imported equipment, the contents of the raw materials are clearly clarified and approved.

Is it an implantable device?

●Demand judgment medical equipment is implantable equipment, which is a long-term contact medical equipment that exceeds 30 years of contact time.

What about raw materials that come into contact with body fluids?

●Consideration of biological safety trends, demand confirmation whether direct or direct contact with body fluids or partial raw materials. .

● Immediate delivery means implantable products, non-contact structures or body fluids, and raw material changes that require no demand.

Useful precedent?

●Confirm whether the raw materials are correct or not after the change, and whether the raw materials are the same or not, and whether the parts of the raw materials that come into contact with the biological body, the time of contact, etc. are the same.

●If the raw materials are lost, there will be a change in production, but there will be a change in the way we proceed, and there are precedents for this problem.

Is it possible to change the quality, effectiveness and safety of the product?

●Confirm demand, whether or not it is possible, impact quality, effectiveness and safety changes. According to Article 47 of the Implementation Regulations, there are no fixed changes, possible effects, quality, effectiveness and safety, but minor changes.

Is this a change in terms of raw materials?

●Due to the details of the raw materials, there may be changes in the raw materials, and if there are any changes in the raw materials, please confirm the demand or not.