Creating attachments
Updated: July 2024, 9
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This section explains how to create attached documents.
Creation unit of attached document
| (1) | As a general rule, one manufacturing and marketing approved item (hereinafter referred to as "approved item"), one manufacturing and marketing certified item (hereinafter referred to as "certified item"), or one manufacturing and marketing notification item (hereinafter referred to as "notified item"). One type of package insert will be created for each product, but in view of the characteristics of the product, it will be easier for users to understand if a product group based on a series of different approved products, such as artificial joints, is listed in one package insert. In some cases, it is acceptable to list a series of product groups together. |
| (2) | If multiple products are included in one approved item, one certified item, or one notified item, and the medical device only functions as a combination of these products, creating package inserts for each individual product will mislead users. If there is a risk, multiple products may be listed in one package insert. |
| (3) | Among medical devices that have accessories (including consumables that need to be replaced periodically) in addition to the main unit, if only the accessories are distributed, even if they have the same approval, certification, or notification, In order to avoid misunderstandings among users, the attached documents for accessories should be prepared separately from the attached documents for the main unit. However, for accessories that have the same approval, certification, or notification as the main unit, some of the information may be abbreviated by clearly indicating the main unit used in combination. |
| (4) | Traditionally, it has been difficult to provide information through the package insert alone, and for medical devices that have instruction manuals, it has been possible to integrate the package inserts by writing the contents of the package insert at the beginning of the instruction manual. There is no problem. |
| (5) | When selling medical devices to medical institutions, etc., it is necessary to meet the conditions such as the information contained in the package insert being posted on the website of the Pharmaceuticals and Medical Devices Agency, and to obtain the consent of the medical institution, etc. to which the product is sold. The attachment of these package inserts to the product may be omitted only if the product is available (Related to Article 63-26, Paragraph 0901 of the Act). For this purpose, please refer to ``Notes on omitting items included in package inserts for in vitro diagnostic drugs and medical devices'' dated September XNUMX, XNUMX, No. XNUMX No. XNUMX of the Pharmaceutical and Food Safety Bureau. |
General notes on writing
| (1) | For medical devices for which it is difficult to provide safety information through package inserts alone and a separate instruction manual exists, it is acceptable to include the package insert at the beginning of the instruction manual and integrate it together. However, even in this case, the package insert must follow the instructions in this notification. |
| (2) | When creating and describing package inserts, try to make the contents consistent with existing similar medical devices as much as possible. |
| (3) | The description of each item should be carefully considered and written in easy-to-understand language, using illustrations and photographs of the product, while ensuring visibility by considering font size, line spacing, font, etc. Additionally, it is desirable to describe all items as much as possible, but if there is no appropriate information to describe, it is acceptable to omit the "item name" as well. |
| (4) | Each item of "(15) Approval number, etc.," "(XNUMX) Classification and general name, etc.," "(XNUMX) Brand name," "(XNUMX) Purpose of use or effect," and "(XNUMX) Approval conditions." When describing, please include the materials attached at the time of manufacturing and sales approval (hereinafter referred to as "approval"), manufacturing and sales certification (hereinafter referred to as "certification"), or manufacturing and sales notification (hereinafter referred to as "notification"), or the details of the approval, certification, or notification. Please describe accurately. |
| (5) | Approval or certification is required for each item from "(12) Warning" to "(16) Shape, structure and principle, etc." and from "(298) Method of use, etc." to "(XNUMX) Storage method and expiry period, etc." The contents shall be the same as the contents of the documents attached or the contents of approval or certification (for the medical devices for which notification has been made, within the medically and pharmaceutically accepted range (Ministry of Health, Labor and Welfare Notification No. XNUMX of XNUMX (hereinafter referred to as "Classification Notification shall be described within the scope of the general name in ). |
| (6) | For those that have been integrated by attaching the conventional package insert at the beginning of the instruction manual, the description of the package insert in "(14) Instructions for use, etc." and "(XNUMX) Matters related to maintenance and inspection" It is acceptable to provide a summary of the information and include a statement to refer to the instruction manual. |
| (7) | When describing each item from "(17) Warning" to "(XNUMX) Name of marketing authorization holder and manufacturer, etc.," the item name must be clearly stated before writing. Use what is shown in the Director-General's notice, and do not enter any other information. However, the item name "Purpose of Use or Effect" may be replaced with "Purpose of Use" or "Effect." |
| (8) | When filling out each of the items "(11) Shape, structure and principle, etc.", "(13) Clinical results" and "(XNUMX) Storage method and shelf life, etc.", accurate descriptions based on scientifically supported literature and other sources that are deemed to be highly credible must be provided in principle. In such cases, the sources must be clearly stated. Furthermore, statements that give the impression that exceptional data is a general fact must not be used. |
| (9) | When writing important items such as item names, take measures such as using Gothic fonts or increasing the font size to ensure visibility. |
| (10) | Considering the convenience of medical professionals, the format and specifications of medical devices for physicians should be A1.7 size (with XNUMX cm left binding margin) as a general rule. However, in the two cases below where it is difficult to do so due to the characteristics, it is acceptable to use formats other than AXNUMX size as an exception if all the respective requirements are met. 1) Case 1 1) It is a general medical device, and the packaging is small and it is impossible or extremely difficult to attach an A4-sized package insert due to the characteristics of the product. ② All information that should be included in the package insert and instruction manual is written on the container or envelope. ③ Be ready to provide A4 size package inserts at all times upon request from users or medical institutions. ④ In this case, there must be a statement on the container or envelope to the effect that ``An A4-sized attached document will be sent upon request.'' 2) Case 2 (1) The product is a controlled medical device, and if A4-sized package inserts were attached to all products, considering the daily usage amount, medical institutions would accumulate a large amount of identical package inserts. ② All information that should be included in the package insert and instruction manual is written on the container or envelope. ③A4 size package inserts must be separately distributed in advance to all medical institutions where the medical device may be sold. ④ Be ready to provide A4-sized attached documents at all times upon request from medical institutions. |
| (11) | When writing each item from "(17) Warning" to "(XNUMX) Name or designation of the marketing authorization holder and manufacturer," unless otherwise specified, in principle, use approximately XNUMX-point type to make it easier to read. care should be taken to ensure that Also, when dividing by paragraph, be sure to use paragraph numbers (for example, (1), (2), (3), etc. for each paragraph). |
| (12) | For products for which an instruction manual is prepared in addition to the package insert, the message ``Be sure to refer to the instruction manual, etc.'' should be written in a prominent place on the first page of the package insert. |
| (13) | Please do not include matters that should already be noted when providing medical care as a medical professional, regardless of individual medical devices. |
| (14) | Avoid ambiguous expressions such as "forcibly," "strongly," "firmly," and "excessively" as much as possible. For parts and parts that require special handling due to the structure of the product, specific guidelines and evidence should be provided. |
| (15) | Do not write descriptions that cannot be handled by users. |
| (16) | When using abbreviations for medical terms, technical terms, etc., write both the official name and the abbreviation at the beginning without omitting the abbreviation, and use the abbreviation in subsequent descriptions. Also, if necessary, add a list of explanatory terms such as words used in the document on the last page of the attached document. |
Items and order of entry
| (1) | Creation or revision date |
| (2) | Approval number etc. |
| (3) | Classification and common name, etc. |
| (4) | Sales name |
| (5) | caveat |
| (6) | Contraindications/prohibitions |
| (7) | Shape, structure, principle, etc. |
| (8) | Purpose of use or effect |
| (9) | How to use etc. |
| (10) | Caution |
| (11) | clinical results |
| (12) | Storage method and validity period, etc. |
| (13) | Handling Precautions |
| (14) | Matters related to maintenance and inspection |
| (15) | Approval conditions |
| (16) | Main documents and references |
| (17) | Name, etc. of marketing agent and manufacturer |
Notes regarding each entry item
| (1) Date of creation or revision | |
| The date and version number of the package insert when it was created or revised must be stated. When a package insert is revised, its continuity must be ensured by making its revision history clear. | 1) The date of creation or revision and version number should be indicated in the upper left corner of the package insert. 2) If an item that has a significant impact on the use of a medical device is revised, it should be described in the following manner. ① The date of creation or revision shall continue to be displayed until each revision is made one after another, and when writing a new revision date, the date of the previous revision (or the date of creation in the case of the second revision) , and write the new revision date in addition to the previous revision date. In addition, separate and clearly indicate the current revision and the previous revision. ② Where the content has been revised, make it easier to identify the revised parts by, for example, adding an asterisk (*) in front of the item and underlining the revised parts. Also, the corresponding revision date and edition number should be marked with the same mark. |
| (2) Approval number, etc. | |
| In addition to writing either the approval number, certification number, or notification number, for single-use medical devices, write ``Do not reuse.'' | 1) As a general rule, either the approval number, certification number or notification number should be written on the right side of the brand name. 2) For single-use medical devices, write “Do not reuse” under the date of creation or revision, and also write in the “Contraindications/Prohibitions” section. |
| (3) Classification and general name, etc. | |
| Enter the general name of the medical device as indicated in Ministry of Health, Labour and Welfare Notification No. 16 of 298 (hereinafter referred to as the "Classification Notification"), the JMDN code, whether it is a highly-controlled medical device, a controlled medical device, or a general medical device, or whether it is a special maintenance-controlled medical device or a controlled medical device. If there are multiple general names applicable to a medical device related to one approval, certification or notification, enter the general name etc. entered in the general name column of the approval, certification or notification, and in parentheses, enter the general name entered in the remarks of the approval etc. | 1) As a general rule, it should be written in an easily visible place above the brand name (in the center). 2) Enter the general name and JMDN code of the medical device as indicated by the classification notification. 3) Classification of highly controlled medical devices, controlled medical devices, general medical devices, specified maintenance controlled medical devices, installation controlled medical devices, specified biological products, and biological products (excluding specified biological products. The same applies hereinafter). Please state the difference. Please note that no description is required for items that are not applicable. |
| (4) Brand name | |
| Please state the brand name. When identifying a product, such as abbreviations and nicknames, do not include names that may confuse users. | 1) Write it in a central, easily visible place in larger letters than the "generic name." 2) If multiple products are approved by one approval or certification, or one notification has been made, and multiple package inserts are to be prepared, the brand name alone cannot identify each product. Since it is not possible to identify each product, it is necessary to specify a name (not a brand name) as a subscript to identify each product. In such cases, follow the example below. In addition, when a name completely different from the sales name is given, or when products that are essentially different, such as those with or without coating or different compositions, are given the same approval, etc., measures such as obtaining separate approval for them as separate items must be taken. ① Add a subscript (number or symbol) after the brand name. Example: ○○ osteosynthesis implant (A), ○○ osteosynthesis implant (B) ② Add identifying characters in parentheses after the brand name. Example: XX tracheostomy tube (cuffed), XX tracheostomy tube (uncuffed) |
| (5) Warning | |
| Describe any particularly dangerous matters that should be noted within the scope of use of the medical device. Subsections should also be created and described for warnings in “Applicable target (patients),” “Concomitant medical devices,” and “How to use.” | 1) Write at the beginning of the text. 26) The information shall be described in accordance with the Pharmaceutical Food and Safety Notification No. 10 No. 1002, “Guidelines for writing precautions for medical devices” dated October XNUMX, XNUMX (hereinafter referred to as “Notice of instructions for writing precautions for use”). |
| (6) Contraindications/prohibitions | |
| Describe the subject matter and usage method that exceeds the scope of responsibility, such as design limits or improper use of the medical device. Sub-sections should also be created and described for contraindications and prohibitions in "Applicable target (patients)", "Concomitant medical devices", and "How to use". | 1) As a general rule, it should be written following the warning, and if there is no warning, it should be written at the beginning of the main text. 2) To be described in accordance with the instructions for describing precautions for use. |
| (7) Shape, structure, principle, etc. | |
| In principle, illustrations, photographs, block diagrams, raw materials, components, etc. are shown so that the overall structure of the medical device can be easily understood, and the principles and mechanisms by which the medical device functions are briefly described. to do. | 1) When using expressions indicating parts of the medical device described in the text of the package insert (e.g., taper part, stopper part, connector part, release handle part, etc.), be sure to include the relevant parts in illustrations, etc. Please use arrows, etc. as appropriate to indicate the point. 2) For medical devices that come into direct contact with the body or are implanted in the body (including those that come into contact with the body through chemical solutions, etc.), the composition of the parts that come into contact with the body (e.g. nickel, chromium, vinyl chloride, etc.) Please also include. 3) Comparisons with other medical devices may be described only if there is sufficiently objective comparison data and the reference medical device is, in principle, a commonly used medical device. Enter the brand name and manufacturer's name of the reference medical device. 4) Other matters related to mere specifications (size variations, operating environment, guaranteed operating conditions, battery operating time, charging time, etc.) must be included. Regarding the guaranteed operation conditions, include the temperature, humidity, etc. expected during normal use. In addition, when describing battery operating time, charging time, etc., please state so that it is clear that the operating time, etc. is when the product is new. |
| (8) Purpose of use or effect | |
| The purpose of use or effect for which the product has been approved or certified shall be stated. In addition, for the medical device for which notification has been made, the description shall be within the scope of the general name definition in the classification notification for the device. | 1) State the intended use or effect for which the product has been approved or certified. 2) Regarding the medical device for which notification has been made, the information shall be described within the scope of the definition of the general name in the classification notification for the device. |
| (9) How to use etc. | |
| Describe the installation method, assembly method, usage method, etc. If there are medical devices to be used in combination, please describe the requirements for those medical devices or the medical devices that can be used in combination. | 1) Describe the approved or certified usage method, etc. However, for the medical device for which notification has been made, the method of use must be described within the medical and pharmaceutically acceptable range. 2) If necessary, use photographs or illustrations of the product to illustrate the operating and usage procedures. When doing so, be sure to clearly indicate the words or phrases in the text that indicate part names using arrows or other means so that the relevant parts can be identified on the product drawings or photographs. 3) For medical devices to be used in combination, describe the requirements for the medical device and the medical devices that can be used in combination. |
| (10) Precautions for use | |
| Describe general precautions when using the medical device. Sub-sections should also be created and described regarding precautions such as "Applicable target (patients)", "Concomitant medical devices", and "How to use". | 1) To be described according to the instructions for writing precautions for use. 2) Among the "Precautions for Use", if there are any precautions related to the purpose of use or effect, such as patients to whom it should be applied, in order to prevent serious malfunctions or accidents, please write them in the section of purpose of use or effect. Next, "precautions related to the purpose of use or effect" should be clearly distinguished from the content of approval, certification, or notification. 3) If there are any precautions related to the method of use, etc., among the "Precautions for Use" in order to prevent serious malfunctions or accidents, they shall be listed following the section on the method of use, etc., as "Precautions for Use Related to the Method of Use, etc.", clearly distinguishing them from the approval, certification or notification details. 4) There is no need to redundantly list in this section the matters that fall under "Warnings," "Contraindications/Prohibitions," (2) and (3) in the "Precautions for Use." |
| (11)Clinical results | |
| Please describe the clinical results, etc. used at the time of application for approval, reexamination, or use results evaluation. | 1) Describe only if there are results of clinical trials used at the time of approval, materials evaluated as substitutes, clinical results used at the time of reexamination or evaluation of use results, etc. 2) Regarding the results of clinical trials conducted precisely and objectively, state of use, period, number of cases, efficacy rate, etc. should be described in accordance with the approved method of use. 3) Do not include any results that suggest "purposes of use or effects" that go beyond the scope of application of the medical device. |
| (12)Storage method and validity period, etc. | |
| State the approved or certified storage method and expiry date. In addition, for medical devices that have a defined useful life or use period, the rationale for this should be stated. Also, describe storage/storage conditions and precautions for storage/storage. | 1) Write down the following subsections: "storage method," "expiry period," and "useful period" (or "use period" depending on the medical device). 2) "Storage method" and "validity period" shall be stated if specified in the approval letter, and shall be as stated in the approval letter. 3) Regarding the useful life, indicate the period (years) during which the medical device can be used after the start of use or the final deadline (years and months) for use of the medical device, and distinguish it from the expiration date. For durable medical devices, the standard usable period should be interpreted as the service life. If there is any relevant information in the attached documents submitted at the time of approval, certification, or notification, the approved, certified, or notified information should be accurately described. It is also permissible to set the service life within the scope of the company's responsibility based on the durability data obtained for the product to date. However, in this case, for validity periods, usage periods, and service lives stated through self-certification, the phrase "[Self-certified (our company data)]" should be added after the period. Furthermore, for devices where a service life cannot be stated, it is permissible to specify the deterioration state, symptoms, or signs indicating the limit of service life for devices where these are known. 4) Regarding the usage period, describe the standard usage period (recommended continuous usage time) for single-use medical devices (once for reusable medical devices). In principle, the period should be based on scientifically supported literature, etc. that is deemed to be highly reliable, and if there is any information in the approval, certification, or notification, the information should be recorded accurately. If the information is not based on the approval, certification, or notification, the source should be made clear. In addition, if the period of use cannot be recorded, it is acceptable to clearly state the state of deterioration, symptoms, signs, etc. that indicate the limit of use. |
| (13) Handling precautions | |
| If handling precautions are specified in the approval or certification standards, approval certificate, certificate, or notification form, those precautions should be described. | |
| (14) Matters related to maintenance and inspection | |
| For medical devices requiring specific maintenance and medical devices that are used multiple times, describe the maintenance and inspection items required for use and the frequency of inspection. For medical devices that are expected to be used multiple times, describe the methods and procedures for cleaning, disinfection, sterilization, etc. | For medical devices that require specific maintenance and that are expected to be used repeatedly, divide them into the following subsections: ``Maintenance and inspection items by the user'' and ``Maintenance and inspection items by the vendor,'' and list them in that order. Additionally, for "Maintenance and inspection items to be performed by the user", the "inspection items" and "inspection frequency (timing)" should be listed, and specific content including the inspection method should be listed in the instruction manual; it is acceptable to state for this item to be "refer to the instruction manual". Similarly, for "Maintenance and inspection items to be performed by contractor," only the "inspection items" and "inspection frequency (time)" should be listed. |
| (15) Approval conditions | |
| If approval conditions are attached, please describe their details. | If the approval conditions are canceled, the description shall be deleted. Also, do not delete it until the approval conditions are met. |
| (16)Main literature and literature request address | |
| Please enter the name and telephone number of the person requesting the literature. | 1) The main data that supports the description of each item should be listed as main documents in this item. In addition, it is desirable to give priority to documents that support the description of clinical results (comparative test results, side effects, etc.). 2) Citation numbers must be provided for any citations from the documents listed as primary documents so that users can search for the documents. 3) Do not list any documents that suggest "purposes or effects" of use that go beyond the scope of application of the medical device. |
| (17) Name, etc. of the marketing authorization holder and manufacturer | |
| The name of the marketing authorization holder (including the designated marketing authorization holder) shall be entered. In addition, if a manufacturer other than the marketing authorization holder performs the main design, the name of the manufacturer shall be stated, and if the manufacturer is a foreign manufacturer, the name of the country and English name of the manufacturer shall be stated. | 1) The telephone number of the manufacturer and distributor shall be a telephone number that can be reached at any time as an emergency contact number. 2) If a manufacturer other than the marketing authorization holder conducts the main design, state the name of the manufacturer, and if it is a foreign manufacturer, state the name and country of the foreign manufacturer. Must be described. In this case, since the name of the foreign manufacturer may not necessarily be accurately expressed in Japanese, the English name should also be included. 3) Following this item, it is desirable to provide a field (blank) for entering the contact information of the distributor (agent). |
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