Requirement
Clearly identify which provision of the Essential Principles is being evaluated.
Essential Principles Conformity Checklist for Medical Devices in Japan
The Essential Principles are the safety and performance requirements that medical devices must meet in Japan. The conformity checklist documents which requirements apply to a particular product and links them to the standards, tests, and supporting evidence used to demonstrate conformity.
Map Each Requirement to Its Supporting Evidence
First check the medical device template and latest cited notifications on the PMDA page below; in vitro diagnostic reagents use a separate template. Reference information in the cited-notification list must be assessed for the particular product rather than copied without review.
When explaining conformity with the Essential Principles, assess the applicability of each requirement based on the intended use, structure, principle of operation, use environment, risks, and other characteristics of the device under application.
For applicable requirements, identify which standards, tests, risk management documents, and other evidence demonstrate conformity.
For requirements considered not applicable, document the reason based on the characteristics of the product under application.
It is important that the checklist follows the same rationale as the STED, test reports, risk management, clinical evaluation, and labeling.
Five Points to Review When Preparing the Checklist
The following are practical review points, not the column structure of the official template.
Applicable or Not Applicable
Determine applicability based on the intended use, structure, principle of operation, use environment, and other product characteristics.
Method of Conformity
Describe the method used to confirm conformity, such as JIS, ISO, IEC, notifications, guidance, or test methods.
Supporting Evidence
Identify supporting documents such as test reports, risk management documentation, clinical evaluation, and labeling.
Reference Location
Record the document number, version, chapter, section, or other reference so that the supporting evidence can be traced from the checklist.
Main Supporting Evidence to Review According to Product Characteristics
Risk Management
Review hazard identification, risk evaluation, risk-control measures, and evaluation of residual risks.
Design, Performance, and Safety
Map product specifications, design verification, performance testing, durability, stability, and related evidence according to product characteristics.
Biological Safety
Review supporting evidence based on the site and duration of body contact, raw materials, manufacturing processes, and related factors.
Infection and Microbial Contamination
For products involving sterilization, reuse, cleaning, or disinfection, map the necessary evaluation documents.
Electrical, Mechanical, and Software Safety
For applicable products, review standards and test documentation for electrical safety, EMC, mechanical safety, software, and related areas.
Clinical Evaluation
When clinical safety and effectiveness need to be explained, map clinical study results, Clinical Evaluation Reports (CERs), literature, and related evidence.
From Applicability Assessment to Cross-Checking the Application Dossier
- 01
Check the Template, Cited Notifications, and Product Characteristics
Select the medical device template and latest cited notifications, then confirm intended use, structure and principle, patient contact, and use environment.
- 02
Determine Applicability of Each Requirement
For each requirement, determine whether it applies and document the rationale.
- 03
Define the Method of Conformity
Set the standards, test methods, risk management approach, and other methods to be used.
- 04
Map Supporting Evidence
For each requirement, identify the supporting documents and relevant reference locations demonstrating conformity.
- 05
Cross-Check the STED and Other Application Documents
Confirm that the checklist is consistent with the STED, test documentation, risk management, clinical evaluation, labeling, and other application materials.
Common Points Overlooked During Preparation
- No rationale is provided for requirements marked not applicable
- A standard is listed without clearly identifying the applicable version
- The test report used as evidence cannot be identified
- The checklist and STED are inconsistent
- Linkage with risk management is unclear
- The relationship between the tested model and the model under application is not explained
- Risk-control measures that should appear in labeling or precautions for use are not reflected
Frequently Asked Questions
Must Every Essential Principle Be Marked as Applicable?
+
No. Applicability should be determined according to the product characteristics. If a requirement is not applicable, the reason should be explainable.
Can Conformity Be Demonstrated by Using ISO or JIS Standards?
+
Standards are important evidence, but simply listing a standard is not sufficient. It is necessary to identify which tests or documents demonstrate conformity with each requirement.
How Does the Checklist Relate to the STED?
+
The standards and supporting evidence identified in the Essential Principles conformity checklist must be consistent with the safety, performance, and other information explained in the STED.
Official Sources
For the Essential Principles and conformity checklist used in Japan, refer to the following official sources.
Contact Us About Approval Application Documentation
We review the Essential Principles conformity checklist, STED, test documentation, and related materials to support consistency across the application dossier.
Preparing a Medical Device STED in JapanApproval, Certification & Notification Support