Application for change in approval/certification
Updated: July 2024, 9
Support Administrative Scrivener Corporation provides support for applications for partial change approval and complete changes to products that have received medical device manufacturing and sales approval and medical device manufacturing and sales certification.
We will support those who are completing the procedure for the first time, or those who find it difficult to handle it in-house, with our resources and know-how.
Please feel free to contact us if you are having trouble applying for medical device manufacturing and sales approval, partial change approval, or complete changes to medical device manufacturing and sales certification.
Partial change of approval/certification Cases where application for approval/complete change is required
According to the Pharmaceutical Biomedical Devices Review No. 29 No. 7 of July 31, 0731, “Handling of minor change procedures, etc. associated with partial changes to medical devices,” partial change approval (complete change) is required in the following cases: It has been.
| ① | Changes that increase existing risks or create new risks regarding product quality, efficacy, or safety, and the impact on human life and health cannot be said to be clearly minor. |
| ② | Changes in which the impact on the quality, efficacy, and safety of the product cannot be fully estimated, and the impact on human life and health cannot be said to be clearly minor. |
| ③ | Changes in the shape or structure of a product that do not clearly result in loss of product identity (small-scale changes that, if repeated, will result in loss of product identity; changes that result in significant changes in shape) (Changes that make it difficult to identify the product, changes that substantially change the method of use, etc. due to significant structural changes.) |
Approval/Certification Partial Change Approval Application/Scope of Change
The Ministry of Health, Labor and Welfare has published a decision tree that indicates in which cases it is necessary to apply for partial change, approval, or make a complete change to approval/certification.
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Changes related to labeling and efficacy
| Is there a change in sales name? | ●If the brand name is changed, an application for partial change approval is required. Please note that if additional items are added, the application will be submitted as a separate item. ●In the event of a force majeure event, such as a trademark at the time of a merger, we can respond to minor change notifications as already notified. |
| Does the change affect the intended use? | ●Whether the change will affect the intended use (including classification of use in contact lenses, from peripheral application to central application, etc.) should be considered in addition to noting it in the "Intended use and efficacy column" of the approved matters. ●For example, changes in contact lenses for astigmatism fall under this category. |
| Changes in warnings, contraindications, or precautions? | ●Warnings, contraindications, and precautions are usually outside the scope of approval and certification, so no approval/certification procedures are required, but please consider consulting with the PMDA Safety Department. |
| Is this a change to make the operation/use method clearer? | ●In the “Operation method or usage” column of the approval/certification application form, you only need to describe the basic operation method, so adding or changing the description to make it more clear and easy to understand is “no procedure required”. However, internal document management is required. ●Changes that go beyond the level of clarifying the method of use include changes to a method of use that is less invasive, and in this case would be No. |
| Is the change likely to affect efficacy or safety? | ●If there is no risk of affecting efficacy or safety, there is no need to proceed, and cases such as those indicated in notifications will be submitted as minor change notifications. ●An example of a case where there is a risk is changing the method of use to one that is less invasive to the patient, which may affect safety. Additionally, the addition of continuous wear to contact lenses has an impact on efficacy and safety. ●An example of a case where there is no risk is when, as indicated in the notification, a combination medical device is listed in the approval document, and the combination with the device has been evaluated in a new device review. This includes the addition of new equipment. Other changes that are not subject to approval, such as changes to the logo mark, explanatory text on package inserts, and product names (such as names that are not branded names), do not require any procedures as there is no risk of affecting efficacy or safety. Become. |
Changes in products and technology (excluding raw materials)
| Is it a change in the operating principle? | ● Is it a change in the mode of operation or mechanism (principle) of operation by which the device achieves its intended purpose? Consider changes to the operating principle that will significantly affect the performance of the device. We will also consider changing the control mechanism of equipment, such as changing from electromechanical control to microprocessor control. ●For example, there is the difference between steady flow and pulsatile flow in the function of artificial heart pumps, and the change from the method of guiding lamp light using a fiber in the light source of an endoscope to the method of emitting light directly at the tip. . |
| Does the change affect the intended use? | ●Whether the change will affect the intended use (including classification of use in contact lenses, from peripheral application to central application, etc.) should be considered in addition to noting it in the "Intended use and efficacy column" of the approved matters. ●For example, changes in contact lenses for astigmatism fall under this category. |
| Changes in warnings, contraindications, or precautions? | ●Warnings, contraindications, and precautions are usually outside the scope of approval and certification, so no approval/certification procedures are required, but please consider consulting with the PMDA Safety Department. |
| Is it a change in the type of energy? | ●Change the power source of the device or the type of power output from the device. Examples include changing from AC to internal power sources, and from ionizing radiation to ultrasound for measuring physical characteristics. |
| Is there a change in performance or specifications? | ● Examine whether there are any changes to the performance, functionality, and specifications of the equipment to achieve its intended purpose. This also includes significant changes in the environment in which the intended equipment will be used. ●For example, when adding ancillary functions to medical electrical equipment, improving the bending strength of artificial hip joints, the tensile strength of catheters, the balloon pressure resistance of balloon catheters, repeated expansion, the clearance value of dialyzers, or the resistance to MRI. is applicable. |
| Ergonomic changes to the patient/user interface? | ● Consider any changes to the device and patient/user interface. ●For example, various warning sounds and flashing alarms to notify the user of dangerous conditions, the layout of the control panel, and the method of presenting information to the user. |
| Is it a change in size or shape? | ●Will the physical dimensions and shape of the equipment change? Dimensional specifications include the length, width, thickness, or diameter of the equipment and the location of parts and components of the equipment. |
| Is there a change in the validity period of approval items? | ●If the validity period based on the stability of the item does not exceed 3 years and a period is set for approval/certification, select Yes if the period is to be extended. Please refer to Yakushokuki Hatsu No. 0905001 (dated September 20, 9) to determine whether a minor change notification applies. |
| Is there a change in sterile packaging? | ●As stated in Attachment 1023001 of Yakushoku Kikai No. 1023001 (dated October 20, 10), consider whether to change the packaging material, thickness, or form within the range guaranteed by sterilization validation standards. |
| Does the change affect the intended use? | ●Whether the change in the medical device itself will affect the intended use (including changes in the classification of use in contact lenses, changes from peripheral application to central application, etc.), as well as the description in the ``purpose of use and efficacy column'' of the approved matters. To consider. |
| Is clinical evaluation necessary to establish efficacy/safety? | ●When evaluating the safety and efficacy of a new design, if non-clinical test data alone is insufficient to confirm the validity, at least a partial change approval application is required. For example, if a highly novel treatment function is to be added to an implantable pacemaker, the answer would be yes. Regarding the necessity of clinical trials, consult PMDA as necessary. |
| Are the changes likely to affect the quality, efficacy, or safety of the product? | ●Consider whether it falls outside the scope of the minor change notification stipulated in Article 47 of the Enforcement Regulations. ●For example, if a new risk or an increase in risk is assumed as a result of a risk assessment related to a change, it falls under the category of "possible change." ●For "There is no risk of impact", examples are shown in Attachment 1023001 of Yakushoku Kikai No. 20 (dated October 10, 23), and for other cases, please consult in advance. . ●Procedures are not required in cases listed in Attachment 1023001 of Yakushoku Kikai No. 20 (dated October 10, 23) where there is no risk of affecting quality, efficacy, or safety. Applicable. |
Raw material change
| Is it a change in raw materials for the purpose of changing performance/function? | ●It is necessary to clarify the purpose and reason for changing the raw materials, and if the raw materials are changed for the purpose of changing performance or function, it is necessary to apply for partial change approval according to the intended change content, and the chart Judgment should also be made on B. ●Changes in raw materials for items where each raw material is treated as a separate item are not covered by this tree. |
| Is there a change in biological raw materials? | ●Changes to raw materials such as heparin, urokinase, and cell tissue, which are designated as biological products, require a partial change approval application. However, this excludes cases where the response such as notification of minor changes is made clear in the notification etc. |
| Is it a change in the type of raw materials? | ●“Change in the type of raw material” means a change at the level of common name or common name. For example, use the names exemplified in the list on the following pages. ●If there is no change in the "type of raw materials," but there is a change in the raw material supplier or additives, we will respond according to the details specified in the approval document. ●For implantable devices, content equivalent to raw material specifications should be specified in the approval document. |
| Is it an implanted device? | ●Determine whether the medical device in question is an implanted device or a medical device that is expected to be in long-term contact for more than 30 days. |
| Will the raw material come into contact with tissue or body fluids? | ●Biological safety In consideration of biological safety risks, confirm whether the material is a raw material for parts that come into direct or indirect contact with tissues or body fluids. ●Even for implantable products, procedures will no longer be required for raw materials used in areas that do not come into contact with tissues or body fluids. |
| Is there any precedent for its use? | ●Confirm whether the raw materials after the change are the raw materials used in already approved (certified) products, and the parts of the raw materials that come in contact with the living body and the time of contact with the living body are the same or longer. ●If there is no change in the raw materials, but only in the description, there is a precedent for its use in this question. |
| Are the changes likely to affect quality, efficacy, or safety? | ● Check whether the change is likely to affect the quality, efficacy, or safety. As stipulated in Article 47 of the Enforcement Regulations, "changes that may affect the quality, efficacy, or safety of the product" are not considered minor changes. |
| Is there a change in the attached specifications for raw materials? | - In the case where raw materials are specified in detail, although there is no change in the type of raw materials, it is necessary to change the contents of the attached specifications for raw materials listed in the "Raw materials or component parts" column of the approval (certification). Check if it is there. |
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.
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