Japan NEW Notification
■2023/12/14 ISEISANJYOUKIHATSU 1214, 1GO
Note:
Logistics related to medical devices Issues and countermeasures that may arise due to the year 2024 problem, etc. As part of work style reform, upper limits on overtime work will be established. For car driving jobs, overtime limits will be applied from April 2024. The upper limit for the overtime work should be 960 hours per year.
This is known as the so-called logistics 2024 problem, and there is a fear that it will affect the medical device industry as well.
Original:医療機器に係る物流2024年問題等により生じうる課題と対応策について
Ref Translation: Please contact IM Japan for full translation.
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■2023/11/16 IYAKUKISHINHATSU 1116, 2GO
Note:
The basic idea is as follows;
Programmed medical devices that calculate physiological parameters based on test results, etc., for which clinical significance and medical judgment standards have not been fully established, may have clinical significance once they are widely used.
Therefore, even if the targeted clinical significance has not yet been established, the clinical significance of physiological parameters, etc. should be explained by compiling clinical results, etc., and then demonstrated by non-clinical studies and test results regarding mechanical performance. Obtain first-stage approval limited to the intended use or range of effects that can be achieved.
After post-marketing clinical evidence (real world data, etc.) has been established based on the experience of use in clinical settings, applications for approval for partial changes to approval items may be submitted as necessary to obtain second-stage approval. get. Such a development strategy is envisaged.
Original:疾病診断用プログラム医療機器に関する二段階承認の考え方について
Ref Translation: Please contact IM Japan for full translation.
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■2023/11/27 IYAKUKISHINHATSU 1127, 4GO
Note:
What is Promote the Acquisition of International Standards for Innovative Medical Devices?
The MHLW is promoting the spread of innovative medical devices and regenerative medicine products made in Japan around the world. For this reason, it is planned to formulate test methods for efficacy and safety, international standardization of test methods, etc., and promoting early commercialization of products.
This time, the following test methods for medical devices have been formulated. Therefore, please use this as a reference when performing tests for Shonin submission.
・Iliac vein stents: Durability test method for local compression loading of iliac vein stents
・Thrombectomy device in deep vein: Test method for thrombus removal performance
Note from IM Japan:
It is stated that ``For the selection of the actual test method, etc., please take PMDA consultation'' so it seems that you should consult with PMDA before performing the test.
Original:革新的医療機器等国際標準獲得推進事業におけるワーキンググループの・・・
Ref Translation: Please contact IM Japan for full translation.
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■2023/07/20 JIMURENRAKU [Cybersecurity Q&A]
Note:
Q&A for Cybersecurity is released on July, 20th 2023.
<Excerpt from the notification>
Q5: SBOM needs to be attached in the submission document?
A5: No. You do not need to attach SBOM in the submission document.
However, it needs to show document number as evidence.
Q6: What information is required for SBOM?
A6: At least the top-level components of the product and directly contained therein.
Include information about the components that will be used.
Original:事務連絡 令和5年7月20日「医療機器の基本要件基準第 12 条第3項の適用に関する質疑応答集(Q&A)について」
Ref Translation: Please contact IM Japan for full translation.
■2023/10/10 JIMURENRAKU [Q&A: Switching to ISO 80369-3]
Note:
Q&A for Switching to ISO 80369-3 is released on Oct, 10th 2023.
The initial policy was updated. The current connector can be used under some conditions.
You can check the points of this update and may address your questions.
<Excerpt from the notification>
Q1: The notification for switching to ISO 80369-3 in the field of enteral nutrition says blow.
Please let us know when we can use the current old specification connector.
“In the long-term view, it is desirable to develop new products that are both safe and convenient for medical and nursing care. But until this period, old spec connector can bee used if next points are fulfilled.
-It is difficult to use the new specification connector.
-There is a valid medical reason for using the old specification connector.
A1: When a new product that achieves both safety and convenience in medical and nursing care is developed and becomes usable, it is conceivable that both old and new standard products will be replaced with this product. However, in general, it takes time for its development. At present, there is no specific deadline for the use of old specific products.
Original:経腸栄養分野の小口径コネクタ製品の切替えに係る方針の一部見直し_Q&A
Ref Translation: Please contact IM Japan for full translation.
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■Release: Action Strategies in Healthcare for SaMD (Software as a Medical Device)
Note:
MHLW (Ministry of Health, Labor and Welfare) has announced a new packaging strategy for programmed medical devices. It is expected that the regulatory approval for SAMD will be systematic and organized. As many programmed medical devices are being developed around the world, it seems likely that Japan will not be left behind and SAMD approval hopefully takes place in a timely manner.
Original:「プログラム医療機器等実用化促進パッケージ戦略2」の公表について
Ref Translation: Please contact IM Japan for full translation.
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■2023/07/20 JIMURENRAKU [Cybersecurity Q&A]
Note:
Q&A for Cybersecurity is released on July, 20th 2023.
<Excerpt from the notification>
Q5: SBOM needs to be attached in the submission document?
A5: No. You do not need to attach SBOM in the submission document.
However, it needs to show document number as evidence.
Q6: What information is required for SBOM?
A6: At least the top-level components of the product and directly contained therein.
Include information about the components that will be used.
Original:事務連絡 令和5年7月20日「医療機器の基本要件基準第 12 条第3項の適用に関する質疑応答集(Q&A)について」
Ref Translation: Please contact IM Japan for full translation.
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■2023/08/20 JIMURENRAKU [Usability Engineering Q&A]
Note:
Please check its notification how to comply with Usability in Japan market.
Q2: What is the system to confirm Usability compliance?
A2: Manufacturer has to comply with JIS and prepare the compliance report.
Japanese MAH referees its report.
Q3: Do we have to establish the system to comply with JIS after implementation day [Apr. 1st, 2024]?
The report / record to comply with each device, that is not essential at that moment.
Is this interpretation above, correct?
A3: Yes. But after the system establishment [at least until Apr. 1st, 2024],
record should be generated by the established QA system.
Original:事務連絡 令和5年8月10日「医療機器のユーザビリティエンジニアリングに係る基本要件基準の適用に関する質疑応答集(Q&A)について」
Ref Translation: Please contact IM Japan for full translation.
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■2023/08/12, Japan Biocompatibility regulation accept ISO10993-1:2018.
YAKUSEIKISINHATSU 0106, dai1go, Jan.6,2020 [Biocompatibility]
Note:
Based on Jan 6th, 2020 notification related to Biocompatibility, in Japan, we have to submit Biocompatibility test report to comply with ISO10993-1:2018. What is the issue? When you use extracted chemicals for biological safety evaluation. There are many controversial opinions, but it is quite hard to use its evaluation for Japan submission. Most of the case the evaluation is rejected. But at this point, the authority says there is a case to accept the evaluation for systemic toxicity, genotoxicity, Carcinogenicity, reproductive toxicity, Irritation test have a chance to use evaluation data, since toxic data are relatively sufficient.
Note: 10% of submission was rejected by the reason of Biocompatibility.
Ref Translation: Please contact IM Japan for full translated Notification.
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■2023/03/31, YAKUSEIKISHINHATSU 0331, dai8go [Cybersecurity]
Note:
For medical devices that use programs, it is necessary to perform risk management relative to the medical device software life cycle according to JIS T 2304 to ensure safety and basic performance. In addition, JIS T 81001-5-1 must be used to implement cyber security measures throughout the product lifecycle, reduce risks to an acceptable level, and prevent the occurrence and spread of harm to patients. In other words, when applying for product approval of Class III and IV medical devices, it is necessary to demonstrate conformity to JIS T 81001-5-1, etc.
Original:薬生機審発0331第8号 令和5年3月31日「医療機器の基本要件基準第 12 条第3項の適用について」
Ref Translation: Please contact IM Japan for full translation.
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■2022/05/19, Yakuseikishinhatsu 0519, dai2go[Online submission]
Note:
Online application to PMDA can be done by the gateway system is started.
-Notification: Already started
-Submission for approval: From July 1st, 2022
-Business license: From October 1st, 2022
Original: 薬生機審発0519第1号 令和4年5月19日「申請書等のオンライン提出に係る・・・
Ref Translation: Please contact IM Japan for full translation.
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■2022/01/26, JIMURENRAKU [Consultation window for Program MD]
Note:
For applying MHLW consultation request if your program is regarded as medical devices, consultation form is prepared. Please note that Class I device is not required submission.
Original: 事務連絡 令和4年1月26日「プログラムの医療機器該当性の相談窓口」における・・・
Ref Translation: JIMURENRAKU 2022/1/26 "Consultation window for program medical devices"・・・
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