Information Regarding the Digitization of Package Inserts Based on the Revision of the Pharmaceuticals and Medical Devices Act
To our valued customers
Dear Sir/Madam, I would like to extend my best wishes for your continued prosperity. Thank you for your continued patronage of our products.
Following the revision of the “Act on Ensuring the Quality, Effectiveness, and Safety of Pharmaceuticals, Medical Devices, and the Like (Pharmacopoeia Act)” earlier, as of August 1, 2023, paper documentation for medical devices will be generally abolished and viewing of “electronically-based documentation (electronic addendum)” will become the standard practice.
In conjunction with this, we would like to inform you that the attached documents for our medical devices will be changed as follows.
Sincerely
記
Paper IFU enclosure discontinued
In conjunction with the implementation of electronic supplementary documents, the attached documents in paper form will be phased out from December 31, 2023. Therefore, please understand that starting January 1, 2024, products that are not accompanied by attached documents will be mixed with other products.
How to view electronic IFU
Electronic supplementary materials can be viewed on the PMDA website using one of the following methods:
① Using a dedicated application called "Toonwen Navi" on smartphones or tablet devices, how to read the GS1 code attached to the packing box or included with the product.
* How to use Tenbun Navi: "Notice on electronic package insertsPlease see.
② Search by sales name, etc. from the PMDA homepage "Medical Device Information Search" page
Medical device information search:https://www.pmda.go.jp/PmdaSearch/kikiSearch/
① Using a dedicated application called "Toonwen Navi" on smartphones or tablet devices, how to read the GS1 code attached to the packing box or included with the product.
* How to use Tenbun Navi: "Notice on electronic package insertsPlease see.
② Search by sales name, etc. from the PMDA homepage "Medical Device Information Search" page
Medical device information search:https://www.pmda.go.jp/PmdaSearch/kikiSearch/
If you still need a paper IFU
If you would like an attached document in paper form, please contact our branch or office.
Nationwide network: http://www.nihonmedix.co.jp/company/network/
Reference materials
About electronic IFU documents
• Provision of information on product warnings and other relevant details for pharmaceuticals and medical devices
The above