How to Search Medical Device Package Inserts in Japan
PMDA's medical device information search allows you to find package inserts by trade name, generic name, approval or certification number, and other information. When researching similar products, review the intended use, structure, directions for use, warnings, and contraindications together with JMDN and certification-standard information.
Search Fields You Can Use to Find a Package Insert
Use this when you know the official trade name. If an exact match does not return a result, try part of the name.
Use this to search broadly for package inserts in the same product group. Confirm the JMDN generic name before searching.
Use this when the number for the target product is known. It can help identify the product even when the trade name is written differently.
Use this to narrow candidate products when the Marketing Authorization Holder or certificate holder is known.
You can search public information, including package inserts, by trade name, generic name, company name, and other fields.
Steps for Searching by Trade Name or Generic Name
- 01
Collect Information That Identifies the Product
Confirm any information you know, such as the trade name, company name, generic name, and approval or certification number.
- 02
Search Using Part of the Trade Name
Instead of entering a long official name all at once, search using a distinctive term or part of the brand name.
- 03
Search by Generic Name as Well
If the product cannot be found by trade name, or if you are looking for similar products, broaden the search using the generic name.
- 04
Cross-Check the Product Information
Check the company name, number, generic name, and revision date to confirm that you have the package insert for the correct product.
- 05
Review the Items Needed for Comparison
Review the intended use, structure, directions for use, warnings, and contraindications and identify similarities and differences from the product to be submitted.
- 06
Combine the Search with Other Public Information
Also review JMDN information, the certified medical device list, approval information, certification standards, and other public sources.
Items to Review When Researching Similar Products
Compare the target disease, anatomical site, and clinical purpose with the product to be submitted.
Review components, materials, dimensions, operating principle, single-use or reusable status, and other product characteristics needed for comparison.
Review preparation, operation, concomitant devices, placement and removal, number of uses, and other conditions related to the actual procedure.
Review patients or situations in which the product must not be used, serious risks, and procedural restrictions.
Review malfunctions and adverse events, precautions for combined use, storage conditions, shelf life, and post-market safety measures.
Check the trade name, generic name, number, Marketing Authorization Holder, and revision date to avoid confusing different products or old versions.
What Cannot Be Determined from a Package Insert Alone
A package insert is important for confirming intended use, directions for use, and safety information, but it does not contain every test result or detailed specification evaluated during the application. The existence of a similar product alone also does not determine the generic name or regulatory pathway for the product to be submitted.
Review JMDN codes, device classification, certification standards, and public information on approved and certified products together, and assess how differences from the product to be submitted may affect effectiveness and safety.
Related guides: Medical Device Labeling and Package Inserts in Japan · How to Search the Certified Medical Device List in Japan
Common Points Missed During a Search
- Searching only by a brand name without confirming the regulatory trade name or generic name
- Assuming that products with the same generic name also have the same intended use or structure
- Comparing products without distinguishing approved, certified, and notified products
- Referring to old warnings or directions for use without checking the revision date
- Assuming that specifications not shown in the package insert are the same as those of a similar product
Frequently Asked Questions About Package Insert Searches
What Should I Do If I Cannot Find a Product by Trade Name?
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Search using part of the name, the generic name, company name, or approval or certification number. The brand name may differ from the regulatory trade name.
Does a Package Insert Show All Detailed Product Specifications?
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Not necessarily. It may not list every dimension, material, or performance datum. Review approval information, certified product lists, and company public information as needed.
Can I Use a Similar Product's Package Insert Directly as Application Documentation?
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A package insert is reference information for understanding the intended use and safety information of a similar product. You need to identify differences from the product to be submitted and explain your own product using its test results and supporting evidence.
What Should I Check When Using an Older Package Insert for Research?
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Check the revision date and revision history and confirm that the document is consistent with the current product specifications and safety measures. Depending on the purpose of the research, review both the historical and current versions.
We Review Package Inserts and Public Information for Similar Products
We compare intended use, structure, directions for use, and safety information and advise on the tests, documentation, and regulatory pathway that should be reviewed for the product to be submitted.
Contact us about similar-product research