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    Medical device manufacturing and sales industry, manufacturing industry, manufacturing and sales approval and certification

    Attached document Q&A

    Updated: July 2026, 1


    Table of contents

    1. General matters

    2. Creation unit

    3. General notes on writing

    4. Classification and common name, etc.

    5. Sales name

    6. Warnings, contraindications/prohibitions

    7. Shape, structure, principle, etc.

    8. Purpose of use or effect

    9. How to use etc.

    10. Precautions for use

    11. Interaction

    12. Malfunctions/adverse events

    13. Storage method and validity period, etc.

    14. Matters related to maintenance and inspection

    15. Approval conditions

    16. Main documents and references

    17. Name, etc. of marketing agent and manufacturer

    18. Attachment document for accessories

    19. A brief description of the attached document for accessories

    20. Package inserts or instruction manuals for medical devices exclusively for home use

    21. Instruction manual description

    22. Responses regarding revision of package inserts based on these guidelines

    1. General matters

    ①Please explain the ``attached documents, etc.'' in the heading of Article 63-2 of the Act and the ``attached documents'' in this entry guideline.

    "Installed documents, etc." under the heading of Article 63-2 of the Act and "attached documents" in the same article refer to all documents (including instruction manuals, etc.) attached to products as information-providing documents. These guidelines define the requirements for so-called "attached documents" in order to standardize "attached documents" as specified in Article 63-2 of the Act. However, the matters to be included in the attached documents listed in Article 63-2, Paragraph 1 of the Act must be entered in accordance with these instructions, and if other matters cannot be described in the "attached documents," please also include instructions for use. To create documents such as books.

    ② When revising the package insert, is it necessary to consult with the JAXA Safety Department 1?

    (1) For class IV medical devices that are subject to the package insert notification system
    a. When revising the information to be reported, a prior consultation must be conducted using the "Consultation Request Form (Revision of Medical Device Package Inserts, etc.)". However, prior consultation is not necessarily required for revisions that involve approval (as per the draft package insert submitted with the approval application). Prior consultations should be conducted in accordance with the notification from the Revision Consultation Organization.
    b. For revisions other than those specified in the notification, it is permissible to consult in advance using the "Consultation Request Form (Revision of Medical Device Package Inserts, etc.)" form.

    (2) In the case of Class I to III medical devices that are not subject to the package insert notification system, if revisions are made to matters that may have a significant impact, consultation must be conducted in advance using the "Consultation Request Form (Revision of Medical Device Package Inserts, etc.)". Matters requiring consultation should be as notified by the Revision Consultation Organization.

    ③ If I find typos or translation errors in the attached document, can I voluntarily correct it?

    (1) Although documents should be created to avoid typos and translation errors, if it becomes necessary to correct these errors, please follow A2 of this Q&A. Note that typographical errors and translation errors may lead to misunderstandings and incorrect operations when using the device, so these should be carefully checked when creating the document.
    (2) No consultation is required for corrections that do not affect the content (e.g., correcting punctuation marks, ``teni wo ha'', changing formatting such as line breaks, etc.).

    ④ If there is a discrepancy between the description of the product and the package insert due to modification (recall), etc., is it necessary to revise the package insert?

    Promptly make revisions and provide information on the revised contents to medical institutions, etc. Please follow A2 and A3 of this Q&A when making revisions.

    ⑤If a manufacturer, etc., revise a package insert, how long should it retain the package insert before the revision?

    Since the revision history of package inserts is important information for a product, it is desirable to preserve it so that it can be provided upon request until the product is removed from the market.

    ⑥ Should the attached documents (draft) to be attached as materials when applying for approval and certification be prepared according to these guidelines?

    Please prepare based on these entry guidelines.

    ⑦If the draft package insert attached at the time of approval (certification) is to be revised before the start of sales, is it necessary to consult with the Japan Safety Department 1?

    A7: According to A2 and A3 of this Q&A.

    ⑧ How should revised parts be indicated?

    (1) For the first revision, write "*" and for the second revision, write "**" in front of the revised part.
    (2) For the third and subsequent revisions, mark the new revision with "**" and the previous revision with "*" as the history of the two most recent revisions.
    (3) Underline the most recently revised parts.

    Example) In case of new revision

    [HANDRING PRECAUTIONS]

    *1) Be sure to flush with lukewarm water before and after administering nutrients. [To prevent tube blockage due to residues of nutrients, etc. ]
    ** 2) When administering nutrients or flushing with lukewarm water, if you feel resistance during the operation, stop the operation. [If the tube lumen is occluded, the pressure inside the tube will rise excessively, which may cause the tube to break or burst. ]

    (In case of previous revision)

    [HANDRING PRECAUTIONS]

    *1) Before and after administering nutrition, be sure to flush the tube with lukewarm water, etc. [To prevent the tube from becoming clogged with residual nutrients, etc.]
    (4) Furthermore, for revisions that do not affect the content when using the relevant medical device, which falls under A3 (2) of this Q&A, there is no need to clearly indicate the revised part.

    ⑨What points should be kept in mind when integrating the package insert with the instruction manual?

    (1) The size of the attached document is specified in 1. of the instructions for filling in attached documents. According to (10) of “General notes on description”. (2) When revising the package insert, consideration should be given to the format of the instruction manual so that medical institutions can promptly replace it with the latest package insert. (An example is using a binder.)

    ⑩In accordance with the Director-General's Notice on Instructions for Filling in Package Inserts, the Notification No. 495 of the Director-General of Pharmaceutical Affairs dated June 1, 1972, ``Concerning precautions to be included in the package inserts of medical electrical equipment,'' has been abolished. , Will the matters indicated in the notification no longer be required to be included in attached documents, etc.?

    Items that are considered to have already been noted by medical professionals when administering medical care, regardless of the specific medical device, do not need to be included in the package insert. However, matters required to comply with standards such as the Japanese Industrial Standards should be addressed by describing them in instruction manuals, materials, etc. other than the package insert.

    2. Creation unit

    ① For products such as "surgical sets" that have multiple products under one approval, etc., and which are manufactured by combining several of them according to orders, there are two ways to create package inserts: Which of the following is appropriate? (1) Create individual package inserts that correspond to the combination (correspond to the bundled products). For example, if there are 20 types of products under one approval, and 7 types of combinations are actually manufactured and sold, 7 types of package inserts that are consistent with each combination are created. (2) Create one type of package insert that describes all the products under one approval, etc., and the contents of the combination that will actually be manufactured and sold (product names and numbers included in the package, etc.) , prepare a separate document indicating the contents and include it in the package, or write the contents directly on the container/wrapping.

    In principle, (1) is preferable, but (2) is also acceptable. However, in the case of (2), there are some products that are not included in the package depending on the combination in the "shape, structure, principle, etc." item, and a list of included products can be found in a separate document or in the direct container.・Write the information written on the packaging.

    3. General notes on writing

    ① The guidelines do not specify an upper limit on the number of attached documents, but is there a guideline for the number of sheets?

    The maximum number of pages should be 4 pages (8 pages on both sides). If the number of pages increases significantly as a result of covering the necessary information and considering visibility by adjusting the font size and line spacing, please consult with the Organizational Safety Department 1 in advance.

    ② There are items in which the documents attached to the approval application form or approval details must be accurately described, and items in which a summary description is allowed. It may not be possible to write all items on one sheet of paper (estimated). In this case, is it okay to include only the items that should accurately describe the documents attached to the approval application form or the approval details?

    Since the number of 4 pages is just a guideline, in principle, if there are any items that should be included, all items should be included. If there is a possibility that not all items can be filled in, please consult with the Organizational Safety Department 1 in advance.

    ③ Instructions for filling out attached documents 1. of the section manager's notice In (5) of "General notes on description", it is stated that "the content of the documents attached to the application for approval or certification or the content of approval or certification shall be the same as the content", but "(7) Please explain the meaning of ``similar content'' in the sections ``Shape, structure, principle, etc.'' and ``(9) Method of use, etc.''.

    "Similar content" in the "shape, structure, principle, etc." and "method of use, etc." section refers to content that does not deviate from the scope of the approval document or certification.

    ④ Is it not possible to include information other than the specified items in the attached document? For example, can I include my company's logo?

    This is acceptable as long as it does not mislead users and does not interfere with the original purpose of the package insert, which is to provide information.

    ⑤ Is it okay to include barcodes, numbers, etc. on the package inserts to manage the package inserts in-house?

    No problem. Consideration should be given to its position and size so as not to interfere with the content of the main text.

    ⑥ Is it okay to include trademark rights and disclaimers that are generally required to be included in contracts?

    Package inserts are information-providing documents for proper and safe use of medical devices, and it is inappropriate to include information on trademark rights, disclaimers, etc. If it is unavoidable to include it, please consider its position and size so as not to interfere with the content of the main text.

    ⑦ For devices such as respirators, accessories such as breathing circuits are connected to the main body, but if the accessories are approved separately from the main body, is it possible to write them simply as if they were the same approved item?

    A simplified description in the package insert of an accessory that is a medical device is a special exception only when the accessory has the same approval as the main unit and only the accessory is distributed independently.In that case, the main unit to be used in combination must be clearly stated. Approved when doing so. Therefore, abbreviated descriptions in the package inserts of accessories that are separately approved are not permitted.

    ⑧Should the contents of package inserts for similar medical devices be unified as much as possible?

    It is desirable to unify. If the purpose of use, effect, shape, structure, principle, etc. are the same, there are likely to be no major differences in warnings, contraindications, prohibitions, and expected adverse events, and manufacturers of similar medical devices or It is desirable to standardize the content within the industry. However, if there are differences in materials, methods of use, indwelling methods, etc., precautions will be written according to those characteristics, and it is not necessarily necessary to unify all descriptions.

    ⑨Requirements for filling out attached documents 1. (13) of “General notes on description” and 1. of “Notice of precautions for use”. Paragraph (7) of the ``Principles of Precautions'' states that ``do not include matters that should already be noted when providing medical care as a medical professional, regardless of the specific device.'' But what kinds of statements are there that correspond to this?

    (1) In light of the current situation where important information is not being accurately conveyed to users due to the overall increase in the amount of information in the package insert, the content has been reviewed based on the importance of the cautionary information, and it has been decided that it is not necessary to include information that is considered to have already been taken into consideration by healthcare professionals when providing medical care, regardless of whether or not information has been provided by the company. Examples are shown in Appendix 1. However, even if the content falls under these examples, if it is thought that it is necessary to include it depending on the circumstances of the individual medical device, a consultation on revision should be made in advance to the Safety Department 1 of the Japan Medical Devices Agency using the "Consultation Request Form (Revision of Package Insert for Medical Devices, etc.)" form. (2) It is permissible to voluntarily include the descriptions exemplified in Appendix 1 in instruction manuals, materials, etc. other than the package insert. (3) Efforts should be made to avoid including information that is common sense when using the medical device as much as possible.

    ⑩ 1. Instructions for filling in attached documents Item (14) of ``General notes on writing'' states that ``vague expressions should be avoided as much as possible.'' What does this mean? Also, if such expressions are unavoidably used, how should they be described?

    (1) The following are examples of "ambiguous expressions" that do not convey the cautions that users should take. Examples: 1) Be careful not to apply excessive force to this product. 2) Handle this product with care. (2) If it is unavoidable to use expressions such as "forcefully," "strongly," "firmly," or "excessive," specify the parts or areas that require particularly careful handling due to the product's structure, and include the reasons for this (risks, etc.). The following are examples.

    Example)

    Inappropriate description

    Appropriate description

    ①infusion set

    Connect firmly to the intravenous indwelling needle, etc.

     

    When connecting to an intravenous indwelling needle, etc., be sure to tighten it firmly to prevent it from loosening or coming off.

    ②gastrostomy tube

    Do not apply unnecessary external force to the indwelling tube.

     

    Do not apply excessive stress to the indwelling tube, such as by pulling or bending it excessively. [This may cause tube damage, fluid leakage, or unintentional removal. ]

    ⑪1. What is the ``description that the user cannot respond to'' indicated in (15) of ``General notes on descriptions''?

    Examples of "descriptions that the user cannot handle" are given below, and the reasons are given below.

    Example)

    Descriptions that cannot be handled by the user

    the reason

    nasal feeding tube

    Be sure to take X-rays during tube insertion and placement to confirm that the tube tip is placed in the appropriate position.

    In the case of patients receiving home treatment, it is impossible to perform X-ray photography, so other confirmation methods such as aspiration of gastric juice or listening to the sound of bubbles should also be presented.

    4. Classification and common name, etc.

    ① 3. Instructions for filling in attached documents. In (3) ``Type and general name, etc.'' of ``Description Instructions,'' ``If there are multiple general names applicable to a medical device pertaining to one approval, certification, or notification, (...) ” However, in the case of items that constitute dozens of medical devices in one approval document, etc., the number of generic names to be written becomes enormous. In this case, is it still necessary to list the generic names of all medical devices?

    Examples of "descriptions that the user cannot handle" are given below, and the reasons are given below.

    Example)

    Descriptions that cannot be handled by the user

    the reason

    nasal feeding tube

    Be sure to take X-rays during tube insertion and placement to confirm that the tube tip is placed in the appropriate position.

    In the case of patients receiving home treatment, it is impossible to perform X-ray photography, so other confirmation methods such as aspiration of gastric juice or listening to the sound of bubbles should also be presented.

    ② If multiple medical devices are included in one approval, etc., and each has a different generic name, if you want to create separate package inserts for each generic name (or each product), Is it necessary to list the generic names of all medical devices?

    Even if the package inserts are prepared separately, all information is required in principle (see Q23). However, if there is a risk of misunderstanding among users due to reasons such as differences in how the medical device is used, please use some of the applicable generic names listed in the notes section of the approval document, etc. It is acceptable to create separate package inserts for medical devices.

    Example) When the approval document contains multiple generic names

    Typical generic names listed on approval letters, etc.: "Aortic cannula" Generic names listed in the notes section of approval letters, etc.: "Aortic cannula," "Coronary artery cannula," "Ventricular cannula," etc.

    5. Sales name

    ① Is it okay to write nicknames, abbreviations, product names such as combination products, etc., as long as they are clearly distinguished from the brand name?

    Since listing multiple names may cause confusion, use of any brand name other than the one used at the time of approval (certification) application and notification is not permitted.

    6. Warnings, contraindications/prohibitions

    ①What items should be included in the “Warning” section?

    The contents that should be written in "Warning" are as follows. (1) Among the matters related to the applicable target (patient), applicable site, and lesion, complications that cannot be avoided even when used appropriately Examples: ・ Intestinal perforation due to colonic stent ・ Liver rupture due to radiofrequency ablation Recurrence and metastasis due to dissemination of cancer cells, damage to adjacent tissues (2) Items where there is concern about the occurrence of serious adverse events or malfunctions Examples: ・Coronary artery or cardiac strangulation due to adhesion of epicardial implantable pacemaker leads ・Strangulation of the Trachymask Occlusion of the tracheostomy tube due to misalignment of the attachment position - Tearing or blockage of the catheter due to the subcutaneous port being pinched between the first rib and clavicle - Damage, movement, or blockage of the inferior vena cava filter due to long-term indwelling - Ureteral stent stent Formation of ureterarterial fistula due to long-term indwelling - Falsely high blood sugar levels due to maltose-containing infusions or administration of pralidoxime methyl iodide - Antiplatelet therapy after coronary artery stent placement (3) Previously reported Items based on medical accidents, etc. Example: Cases in which patients did not notice sudden changes in the patient because they did not hear the warning sound of the biological information monitor. Notes other than these should be included in the ``Precautions for use'' section. A26: The contents that should be written in the "warning" are as follows. (1) Among the matters related to the applicable target (patient), applicable site, and lesion, complications that cannot be avoided even when used appropriately Examples: ・ Intestinal perforation due to colonic stent ・ Liver rupture due to radiofrequency ablation Recurrence and metastasis due to dissemination of cancer cells, damage to adjacent tissues (2) Items where there is concern about the occurrence of serious adverse events or malfunctions Examples: ・Coronary artery or cardiac strangulation due to adhesion of epicardial implantable pacemaker leads ・Strangulation of the Trachymask Obstruction of the tracheostomy tube due to misalignment of the attachment position - Tearation or blockage of the catheter due to the subcutaneous port being pinched between the first rib and clavicle - Damage, movement, or blockage of the inferior vena cava filter due to long-term indwelling - Inferior vena cava filter damage, etc. Formation of ureterarterial fistula due to long-term indwelling - False high blood sugar levels due to maltose-containing infusions or administration of pralidoxime methyl iodide - Antiplatelet therapy after coronary artery stent placement (3) Previously reported Items based on medical accidents, etc. Example: Cases in which patients did not notice sudden changes in the patient because they did not hear the warning sound of the biological information monitor. Notes other than these should be included in the ``Precautions for use'' section.

    ② What items should be included in the “Contraindications/Prohibitions” section?

    (1) Complications that are unavoidable even when the device is used appropriately, among those related to the target patients, application site, and lesion. Examples: Intestinal perforation due to a colonic stent; Liver rupture and recurrence/metastasis due to the seeding of cancer cells, and damage to adjacent tissues, during radiofrequency ablation. (2) Matters for which there is concern about the occurrence of serious adverse events or malfunctions. Examples: Coronary artery or cardiac strangulation due to adhesion of an epicardially implanted pacemaker lead; Blockage of a tracheostomy tube due to a misalignment of the tracheal mask; Rupture or blockage of a catheter due to pinching of a subcutaneous port between the first rib and the clavicle; Breakage, migration, or blockage of an inferior vena cava filter due to long-term placement; Formation of a ureteroarterial fistula due to long-term placement of a ureteral stent; False high blood glucose levels due to infusion of maltose or administration of pralidoxime methyl iodide; Antiplatelet therapy after placement of a coronary artery stent. (3) Matters that take into account medical accidents that have been reported to date. Examples:・A case where the alarm sound from the vital signs monitor was not heard and a sudden change in the patient's condition was not noticed. Any other precautions should be listed in the "Precautions for Use" section. A26: The contents that should be listed in the "Warnings" section are as follows: (1) Examples of complications that are unavoidable even when used appropriately, among those related to the target patients, application site, and lesions) Intestinal perforation due to colonic stents Liver rupture and recurrence/metastasis due to seeding of cancer cells, and damage to adjacent tissues during radiofrequency ablation (2) Examples of matters for which there is concern about the occurrence of serious adverse events or malfunctions) Coronary artery or cardiac strangulation due to adhesion of epicardially implanted pacemaker leads Blockage of tracheostomy tube due to misalignment of tracheal mask attachment position Rupture or blockage of catheter due to pinching of subcutaneous port between the first rib and clavicle Breakage, migration, or blockage, etc., due to long-term placement of inferior vena cava filter Formation of ureteroarterial fistula due to long-term placement of ureteral stent False high blood glucose level due to infusion of maltose or administration of pralidoxime methyl iodide Antiplatelet therapy after placement of coronary artery stent (3) Examples of matters taking into account medical accidents, etc. that have been reported to date) - A case in which the alarm sound from the vital signs monitor was not heard and a sudden change in the patient's condition was not noticed. Any other precautions should be listed in the "Precautions for Use" section.

    ③ Is it okay to set contraindications and prohibitions for applications for which there is no experience of using the drug?

    (1) Unless there is a clear possibility that the occurrence of a fatal or extremely serious and irreversible adverse event or the occurrence of a malfunction will lead to an extremely serious adverse event, mere lack of experience with use may be considered contraindication. It is not appropriate to set it as prohibited.

    (2) Warnings regarding applications for which there is no prior experience should be given in 3. of the Precautions for Use Guidelines. In accordance with the "Description Instructions", please state, for example, "We have no experience with the use of ○○, and its safety has not been established."

    ④ 3. Precautions for use In (2) ``Contraindications/Prohibition'' 6) of ``Information Guidelines'', the matters to be described in the ``Contraindications/Prohibition'' section are ``in principle consistent with the ``purpose of use or effect'' that has been approved, certified, or notified.'' ”, but is the following statement appropriate? ①PTCA guide wire: Do not use in blood vessels other than coronary arteries. ② Cast cutter: Do not use it for any purpose other than removing cast bandages.

    Inappropriate. It goes without saying that it must not be used for any purpose other than its intended purpose or effect, and there is no need to state it.

    ⑤ For warnings related to "How to use, etc.", omit the warning at the beginning, and write them in a red frame in the section "Precautions related to how to use, etc." under "How to use, etc." Okay?

    Items related to “warnings” and “contraindications/prohibitions” should be placed at the beginning to attract the most attention, and even if they are related to other items, they should be placed at the beginning. As a general rule, duplicate entries should not be made, but if you dare to include matters related to "Warning" in the "How to use, etc." section, please mark the important information with a red frame in the "Warning" section at the beginning. In the section of ``Precautions related to usage, etc.'', please write in detail the matters related to ``warning'' without a black frame.
    Please do not use the red frame except for the "Warning" and "Contraindications/Prohibitions" sections at the beginning.

    ⑥ 3. Precautions for use In (1) of ``Warnings'' in 5) of ``Description Instructions'', it is stated that ``If there are any special precautions or emergency measures for malfunctions or adverse events that occur during use, please briefly describe them.'' Is it necessary to describe emergency measures?

    In the "Warnings" section, only important precautions and first aid measures that may affect the lives of patients and users should be included. Other troubleshooting information should be listed in the "Important Notes" section.

    ⑦The warning document shown in the notification from the Director of the Safety Division, Pharmaceutical Safety Bureau, Ministry of Health and Welfare, dated March 25, 1999, "Revision of the information included in the package inserts of medical devices containing natural rubber" is "Precautions for Use". In which section should it be stated? Is it permissible to describe it according to the characteristics of the product?

    (1) The items that should be noted may differ depending on the characteristics of the product, such as the purpose of use, period of use, application site, and expected degree of hypersensitivity of the medical device, so please take into account the characteristics of the product. After that, please write in the section that is considered appropriate along with the reason why you decided to include it in that section.
    (2) Regarding raw materials for medical devices that directly or indirectly come into contact with the body or are implanted in the body (including cases that come into contact with the body through medical solutions, etc.), based on the knowledge obtained from the latest papers and other sources. If it is found that there is a possibility of causing hypersensitivity, the same should be stated.

    ⑧ If some of the approved or certified (notified) products include single-use products, is it necessary to state that "reuse is prohibited"?

    "Contraindications/Prohibited" and "Reuse prohibited" should be written in the header section, and details of parts etc. that are suitable for single use should be described in the "Shape, structure, principle, etc." section.

    ⑨ In the “Contraindications/Prohibitions” section, sub-sections are to be created for “Applicable subjects (patients)”, “Concomitant medical devices” and “How to use”, but if any of the above three sub-sections apply If there is no item to be described, can the sub-item name be omitted?

    No problem. However, if there are additional matters to be included and as a result it becomes necessary to include multiple sub-items, the names of the relevant sub-items should be newly entered.

    (10) If items that were previously listed as ``contraindications'' are to be moved to other items, is it necessary to consult about revising the package insert?

    Consult with the Organizational Safety Department 1 in advance.

    11) How should I describe a case where it should not be used, but is unavoidably used in an emergency or for medical treatment?

    The attached document is intended to provide information and alert caution when used appropriately within the scope of approval, certification, or notification, but should not be used in emergencies or unavoidable circumstances. Describe the possible malfunctions and adverse events that may occur when the product is used, and how to deal with them when they occur.
    In addition, when describing precautions when using other medical devices in conjunction with a medical device that is already being used on a patient, such as an implantable medical device, please ensure that the medical device is functioning properly after use. Please describe how to check if there are any.

    ⑫ Red is supposed to be used in the "Contraindications/Prohibitions" and "Warnings" sections, but is it okay to emphasize important items by making the series larger instead of printing in two colors? Also, is it okay to use colors such as yellow or a symbol to call attention to it?

    To avoid user confusion, use red and black instead of making the series larger and using multiple colors. Additionally, symbol marks are currently not standardized and may cause misunderstanding among users, so in principle they should not be used.

    ⑬Are there any precautions to be taken regarding the reasons for setting warnings, contraindications, and prohibitions?

    (1) The warning and contraindications/prohibitions sections should state the reasons for their inclusion as specifically as possible, as these are items that pose particularly high risks. Examples are given below. Example: 1) Artificial ventilator When connecting the breathing circuit to a connector such as a tracheal tube, and after connecting, take care not to apply excessive linear or rotational force to the connection point. [This may result in the connection accidentally coming loose, leading to ventilation failure.] 2) Tracheostomy tube Do not use a laser scalpel or electric scalpel when high-concentration oxygen is flowing near the area where this product is used. [This is because there is a risk of sudden fire or burns due to fire in a high-concentration oxygen atmosphere.] (2) Vague statements such as "There is a risk of serious health damage" are inappropriate.

    ⑭ 3. Precautions for use In the "Description Guidelines", for items set as warnings and contraindications/prohibitions, it is stated that "the basis or reason for setting must be written in [ ]." Does it always have to be in [ ]?

    As a general rule, use [ ]. However, this does not apply if it is easier to read if the reason is written in the text of the warning, contraindication, or prohibition.

    7. Shape, structure, principle, etc.

    ① Previously, size variations were listed in the "item specifications, etc." section, but under these guidelines, which section should they be listed in?

    Among the items that were previously described as "item specifications, etc.", descriptions related to mere specifications such as size variations and operating environment should be described in the "shape, structure, principle, etc." section. This statement is a measure in conjunction with the deletion of the section "Product specifications, etc." from the package insert instructions, and the handling on the approval application form is separately provided in the 1st and 2nd sections of the Japan Medical Device Review Division. Consult with the department and the third department.

    (2) In the case of a group of products such as osteosynthesis materials that have extremely different shapes and dimensions, is it sufficient to display only one example?

    If the shapes, etc. are significantly different, comprehensively list and illustrate the product group.
    In addition, size variations (length, diameter, etc.) of tubes, etc. should be shown in an easy-to-understand way by combining tables, etc. so that the sizes can be understood.

    ③ Previously, operating guarantee conditions, charging time, battery drive time, etc. were described in the section "Storage/storage method and period of use, etc.", but under these guidelines, which items should be described?

    It should be described in the "shape, structure, principle, etc." section as a mere specification.

    ④There are multiple products under approval, certification, or notification, and these products are distributed individually and used in combination at medical institutions (e.g., joints and bolts of artificial joints of orthopedic implants, etc.). Is it necessary to illustrate the overall diagram finally assembled by the institution in the attached document?

    The attached document should include a diagram that shows the combination of products included in the approval, certification, or notification, or a diagram that shows the connections. In addition, in cases where unapproved products are combined, and when such an unapproved product is shown in a diagram, the part should be printed in a lighter shade or Take measures such as shading.

    ⑤ Regarding the composition of parts that come into contact with the body, from the perspective of protecting intellectual property rights, is it okay to omit the description of specific ingredients?

    Considering that this item is intended to raise awareness and provide information about health hazards caused by allergies and the incorporation of chemical substances into the body, all substances that are suspected of causing some sort of health hazard should be listed.

    ⑥ Is it not necessary to list the ingredients for materials used in areas other than those that come into contact with the body?

    No description is required. However, for example, in a medical device containing metal, there is a risk that the medical device may malfunction, move within the body, generate heat, etc. due to the influence of the magnetic field generated from the MR device. Even if the part does not come into contact with the body, cautions should be included if it is thought to affect safety or effectiveness.

    8. Purpose of use or effect

    Q①2. In (8) "Regarding 'purpose of use or effect'" in "Points to note regarding each entry item", it is stated that "the purpose of use or effect that has been approved or certified shall be described". If a product contains multiple products with different purposes or effects, is it okay to create a separate package insert for each product and describe each purpose or effect?

    Even if separate package inserts are prepared, in principle, the approved purpose of use as a whole must be stated. However, if there is a risk of misunderstanding among users due to reasons such as differences in how the medical device is used, please state the approved overall purpose of use and then describe each purpose or effect. , separate package inserts for each medical device may be prepared.

    9. How to use etc.

    1) Is it necessary to describe the installation method and assembly method only if the installation or assembly is performed directly by a medical professional?

    If it is a large-scale device that is installed, assembled, or relocated by the manufacturer (e.g., installed managed medical equipment, etc.) and medical personnel do not perform these tasks independently, omit the description. There is no problem. However, this should be stated in the attached document.

    10. Precautions for use

    ① Even if matters are not stated in the materials at the time of approval or certification, can they be added if there is sufficient evidence?

    This is acceptable as long as it does not deviate from the content of the materials at the time of approval or certification, but depending on the content, simple additions may not be permitted, so please consult with the JAXA Safety Department 1 in advance. is desirable.

    ② When using medical devices, how should cautions regarding necessary treatment be used in combination?

    It should be distinguished from precautions regarding the medical device, so when writing, please state that the risk is related to the treatment used in combination as the basis or reason for setting the relevant item.

    Example) ・Medical devices that require placement under X-ray fluoroscopy

    “Applicable to pregnant women, childbirth, breastfeeding women, children, etc.” in the “Precautions” section

    It should only be used in patients who are pregnant or may become pregnant if the therapeutic benefits outweigh the risks. [This product is placed under X-ray fluoroscopy.] ]

    11. Interaction

    ① It is impossible to cover all clinical combinations, such as when used in combination with other medical devices, so how should the package insert be described?

    For concomitant medical devices, etc. that are expected to be used within the scope of approval, etc., please describe the medical devices, etc. whose concomitant use has been confirmed as a result of your company's risk analysis as follows.

    (1) Regarding medical devices that can be used in combination

    2. of the Director's Notice on Instructions for Filling in the Package Inserts in the "How to Use, etc." section. Fill in the information in accordance with 3) of (9) “How to use, etc.” in “Notes regarding each entry item”.

    (2) Regarding medical devices that cannot be used together or that require caution when used together

    Separate medical devices, etc. that cannot be used together and medical devices, etc. that require caution when used together, and write them in [Concomitant use contraindications] or [Concomitant use precautions] in the "Interactions" section. For information on how to write, see 3. of Instructions for Precautions for Use. Please follow (5) “Interaction” in “Description Instructions”.

    12. Malfunctions/adverse events

    ① 3. Precautions for use How should the mechanism of occurrence of malfunctions and preventive measures, etc. be described in (6) "Defects/Adverse Events" (3) ② of "Description Guidelines"?

    If the mechanism of occurrence of the defect, the period until occurrence, preventive measures, treatment methods, etc. are known, it is desirable to provide a specific description. Also, gather information widely from literature, etc., and list it as the main literature. Furthermore, it is desirable to have a system that can proactively provide information on proper use to medical institutions as necessary.

    13. Storage method and validity period, etc.

    ① If the storage method is not stated in the approval document, how should it be described?

    In cases where no special storage method is required, the description may be omitted, but it is also permissible to include the information as long as it does not deviate from the materials submitted at the time of approval or certification.

    ② Can the description be omitted for medical devices for which the validity period is not specified in the approval document and is difficult to set?

    No problem. However, for sterilized medical devices, the sterilization guarantee period must be set based on in-house data, and the statement ``based on self-certification'' must be included.

    14. Matters related to maintenance and inspection

    1) How detailed should maintenance and inspection be?

    Detailed information that cannot be included in the package insert may be included in the instruction manual. However, at least (1) when (inspection frequency, etc.), (2 ) Describe what kind of maintenance/inspection (inspection items, etc.) needs to be performed.

    ②Which item should be written regarding cleaning, disinfection, and sterilization?

    Describe in the section “Matters related to maintenance and inspection”. In addition, it is acceptable to include detailed information in the instruction manual, and include a statement in the attached document such as ``For details, please refer to Chapter ○ About ○○'' in the instruction manual.

    ③There are parts that need to be replaced regularly, but should they be listed in the package insert?

    Describe in the section “Matters related to maintenance and inspection”. If there are many applicable parts, focus on the most frequently used parts. Additionally, the attached document may include a statement such as ``For details, refer to ``Chapter ○ About ○○'' in the instruction manual.''

    15. Approval conditions

    ① Cattle, etc. as indicated in the Ministry of Health, Labor and Welfare Director-General's Notice of Pharmaceutical Affairs No. 1069 dated October 2, 2001, "Regarding strengthening of quality and safety assurance of pharmaceuticals, medical devices, etc. manufactured using bovine-derived materials as raw materials" Will approval conditions related to changes in raw materials be also included?

    Please list all conditions for approval. However, the description may be deleted after the approval conditions are met.

    16. Main documents and references

    ① Is it necessary to cite literature for all products?

    This item is to be entered when literature is cited, and it is not mandatory to cite literature for all products.

    ② If the name of the marketing authorization holder and the person requesting documents are the same, is it okay to unify these items?

    Although unification of items is not allowed, it is acceptable to write "(same address for requests for literature)" after "name, name, etc. of marketing authorization holder".

    ③What kind of literature do you cite in addition to academic papers?

    Documents that should be considered as cited references include:

    ・Various guidelines
    ・Administrative notices (safety measure notices, self-inspection notices, etc.)
    ・Safety information for drugs, medical devices, etc.
    ・PMDA medical safety information, etc.

    ④ Is it okay to include the cited documents even if they are internal documents?

    No problem. However, please be able to respond to inquiries regarding the content of the documents.

    17. Name, etc. of marketing agent and manufacturer

    ① Is it unnecessary to state the address of the manufacturer/marketer in the package insert?

    Although it is not required, it may be included. It is also acceptable to include the call center's phone number and homepage URL.

    ② Regarding the description of the manufacturer, is it okay to list only the manufacturer that does the main design (the manufacturing facility that does the designing among the manufacturing facilities prescribed in Article 23-2-3, Paragraph 1 of the Act)?

    No problem. If the manufacturer is different from the manufacturer who designed the product, enter the manufacturer who designed the product. Specifically, a case may be considered in which a finished product is imported and accepted by a domestic manufacturer/seller. If the manufacturer and the main design manufacturer are the same corporation, it is sufficient to only state the manufacturer.

    18. Attachment document for accessories

    ① Are attachments required for accessories that are distributed at the same time as the main unit?

    If the package insert for the product contains the necessary information for a product that is considered an accessory, there is no need to create a package insert for the product.

    19. A brief description of the attached document for accessories

    ① Please indicate the cases in which abbreviated descriptions can be provided in the package inserts of medical device accessories.

    For accessories that are included in the same approval as the main body and distributed separately from the main body, it is possible to abbreviate some of the information by clearly indicating on the main body that they are to be used in combination.

    ② Please indicate the guidelines for abbreviated descriptions in the attached documents of accessories.

    The items shown below should be described as follows, and other items may be briefly described. (1) To make it clear that it is an accessory to the main unit, use the same “medical device classification (highly controlled medical devices, etc.)”, “approval number, etc.”, “classification, general name, etc.” and JMDN code as the main unit. ” and “brand name”, and write “◎◎ accessories” as a subscript following the brand name. In addition, the name of the accessory should be written down to the subscript and below the sales name.

    Example)

    adult ventilator

    Accessories of "○○ respirator"

    △△Replacement part AB-123C



    (2) "Name, etc. of the manufacturer and manufacturer": Enter the name, etc. of the manufacturer and manufacturer of the main body and accessories, and the manufacturer name is the name of the manufacturer that manufactures the accessory. Must be described.

    (3) "Date of creation or revision", "Warning", "Contraindications/Prohibitions": Write down the matters related to accessories.

    ③ For specified maintenance management medical devices, if there are single-use accessories that are included in the same approval as the main unit and the accessories are distributed separately from the main unit, when creating a package insert for the accessories, Is it necessary to state “special maintenance management medical device” in the package insert?

    It is not necessary to state in the package inserts of single-use accessories that they are ``medical devices that require special maintenance,'' as this may cause confusion in clinical practice. Also, since it is for single use, it should be marked as ``Do not reuse.''

    20. Package inserts or instruction manuals for medical devices exclusively for home use

    ①Please explain what is meant by "the package inserts or instruction manuals exclusively for medical devices for home use" in this Q&A.

    This includes "package inserts or instruction manuals for home-use medical devices" and "package inserts or instruction manuals for home-use medical devices for patients and their caregivers."

    ②In the package inserts of medical devices exclusively for home use, the expressions ``warning'' and ``contraindications/prohibited'' may be difficult for users to understand, so I would like to make some changes to the expressions. Is it possible?

    2 of the Director-General's Notice on Instructions for Filling in Attached Documents. In the ``Scope of Applicability,'' ``The package inserts or instruction manuals for household medical devices shall comply with these guidelines, but the expression and content may be easily understood by a person with academic ability equivalent to completing compulsory education.'' Please take care to ensure that the information is understandable, and the wording may be changed, but the difference between ``warnings'' and ``contraindications/prohibitions'' and ``general precautions'' should be clearly distinguishable. To keep it.

    ③ Shouldn't the description in Attachment 1, as exemplified in A20 of this Q&A, be included exclusively in the package inserts of medical devices for home use?

    Instructions for filling out attached documents 1. As shown in (7), the content of the information needs to be considered depending on the user receiving the information, and for medical devices exclusively for home use, please refer to the examples in Appendix 1 of this Q&A. The choice should be made depending on the user.

    ④Requirements for filling out attached documents 1. In (10) of "General notes on descriptions," please indicate what types of medical devices for home use are exceptionally permitted to use formats other than A4 size.

    This applies to products whose packaging is so small that it is difficult to include an A4 size package insert, such as condoms and sanitary materials.

    ⑤Can contact lenses be prepared in accordance with the instructions for creating package inserts or instruction manuals for medical devices for home use as shown in this Q&A?

    In view of the nature and distribution of contact lenses, the guidelines for contact lenses shall be based solely on the preparation of package inserts or instruction manuals for medical devices for home use.

    21. Instruction manual description

    ①1. In (12) of ``General notes on information'', if the device requires an instruction manual, it should be stated that ``be sure to refer to the instruction manual, etc.'', but on the first page. Is it okay to include a statement to refer to the instruction manual in addition to the above?

    (1) No problem. It is assumed that the warnings that should be referred to in the instruction manual may not be thorough on the first page alone, so it is okay to include them on other pages as well.
    (2) If detailed information about each item is described in the instruction manual, please include a reference in the relevant item, such as "For details, please refer to Chapter ○ About ○○" in the instruction manual. Please be specific about the chapter and number of pages.

    22. Responses regarding revision of package inserts based on these guidelines

    ① Is it possible to revise the package inserts based on these guidelines before updating the information in approval documents, etc. in accordance with the enforcement of the revised law?

    In view of the importance of promptly providing easy-to-read package inserts prepared based on these guidelines to clinical practice, it is acceptable to revise the package inserts without updating the information in the approval form, etc. (It is unavoidable that there will be discrepancies between the item names of the approval form and the attached documents before and after the preparation of the descriptions.)

    ② How should the revision history be recorded for the first revision based on these entry guidelines?

    (1) Add “(revised based on new entry guidelines)” after “version number”. Example) Version ○ (Revised based on new entry guidelines) (2) "*" and underlines indicating revised parts should not be required in the case of major revisions, as they will complicate the space.　

    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.
    We provide legal services related to medical devices based on the know-how and track record that we can accumulate because we are administrative scriveners who handle applications and negotiations with administrative agencies on behalf of companies on a daily basis.
    Our staff has a track record of applying in all prefectures across the country. Please contact us by all means.

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