Intended Use
Confirm whether the target disease, target patients, anatomical site, and clinical purpose are the same as those of previously approved devices.
APPLICATION CATEGORY
New, Improved, and Generic Medical Devices in Japan
The approval application category is determined by the novelty of the product and its substantial equivalence to previously approved medical devices, not by device classification. The category affects how comparisons are made and how testing and clinical evaluation requirements are considered.
CATEGORY
Three Approval Application Categories
CategoryBasic conceptMain point
New medical device
A medical device whose structure, method of use, effect, or performance is clearly new
Determine the evidence needed to demonstrate effectiveness and safety according to the degree of novelty.
Improved medical device
A medical device that does not fall into either the new or generic category
Explain the differences from previously approved devices and how those differences affect performance, safety, and clinical evaluation.
Generic medical device
A medical device considered substantially equivalent to a previously approved medical device
Prepare comparative documentation demonstrating equivalence together with the necessary performance and safety data.
Actual application categories are determined individually based on the characteristics of the product to be submitted and comparison with previously approved devices.
RELATION TO RISK CLASS
Review the Application Category Separately from Device Classification
Class I-IV classification is based on the risk a medical device poses to the human body. New, improved, and generic medical device categories, by contrast, relate to novelty and equivalence in an approval application.
Even within the same device class, the application category may differ when the structure or intended use is new. Products that fall within the scope of certification standards may also be certified by a Registered Certification Body rather than submitted for approval.
DECISION POINTS
Main Items to Compare with Previously Approved Devices
Structure and Principle of Operation
Review differences in design, operating principle, materials, energy source, software, and other characteristics.
Method of Use
Compare operating steps, users, use environment, concomitant devices, duration of placement, and other conditions.
Performance and Safety
Review specifications, performance, risks, test methods, and acceptance criteria to determine whether additional evaluation is needed.
Clinical Impact
Assess whether the differences may affect clinical effectiveness or safety and whether clinical data are needed.
Selection of the Previously Approved Comparator
Assess whether the selected comparator appropriately represents the characteristics of the product to be submitted and provides the information needed for comparison.
PROCESS
Steps for Considering the Application Category
- 01
Confirm the Characteristics of the Product to Be Submitted
Review the intended use, structure and principle of operation, method of use, specifications, materials, and risks from product documentation.
- 02
Research Previously Approved Devices
Use generic names, approval information, review reports, and public information to identify candidate comparators.
- 03
Compare Similarities and Differences
Present differences item by item and assess their impact on the safety and effectiveness of the product to be submitted.
- 04
Determine Whether Clinical Study Data Are Needed
Assess whether nonclinical testing and existing clinical data are sufficient or whether a new clinical study is needed.
- 05
Define the Application Category and Documentation Plan
Confirm the application documentation, testing, clinical evaluation, and need for PMDA consultation according to the category.
PMDA Information on Ministerial Approval Application CategoriesOpen PMDA guidanceYou can review PMDA information on the definitions of new, improved, and generic medical devices and approval review.
DOCUMENTATION
The Application Category Affects the Scope of Documentation
The method of comparison with previously approved devices and the scope of required documentation vary by application category. In practice, do not determine the evidence solely from the category name. Consider the characteristics of the product to be submitted and its differences from previously approved devices.
- Comparison table with previously approved devices and rationale for selecting the comparator
- Conformity with the Essential Principles and risk management
- Performance, physicochemical characteristics, biological safety, and other test data
- Sterilization, packaging, stability, and transportation documentation
- Clinical study data or a Clinical Evaluation Report
- Consistency among the application form, STED, labeling, and package insert
COMMON PITFALLS
Common Points Missed When Determining the Application Category
- Treating device classification and the approval application category as the same concept
- Applying an overseas approval category directly to Japan
- Selecting a previously approved comparator that does not adequately represent the characteristics of the product to be submitted
- Describing only similarities without assessing the clinical impact of differences
- Failing to reassess the application category after a design change
- Leaving the need for clinical study data unresolved until late in document preparation
FAQ
Frequently Asked Questions About Approval Application Categories
Are Device Classification and Application Category the Same?
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No. Device classification is based on the risk posed by the medical device. New, improved, and generic medical device categories relate to novelty and equivalence to previously approved devices in an approval application.
Is a Device a Generic Medical Device If It Is Already Marketed Overseas?
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Not necessarily. Overseas marketing history alone does not determine the category. Compare the product with previously approved medical devices in Japan and assess whether the intended use, structure, method of use, performance, and other characteristics are substantially equivalent.
Are There Improved Medical Device Categories With and Without Clinical Data?
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Yes. Improved medical devices include categories with and without clinical study data. Assess the clinical impact of the differences and whether nonclinical testing and existing data can adequately address them.
Does a Generic Medical Device Require No Testing?
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Testing may still be required. Documentation is needed to demonstrate substantial equivalence and conformity with the Essential Principles. Depending on the product characteristics, prepare performance, safety, sterilization, packaging, and other evidence.
Can We Consult PMDA About the Application Category?
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If there is uncertainty about the application category or required documentation, consider the applicable PMDA consultation. Confirm the consultation type and scope using the latest PMDA guidance.
CONTACT
You Can Consult Us Even Before a Previously Approved Comparator Has Been Selected
We review product information and overseas documentation, consider potential comparators and the expected application category, and organize the testing and clinical evaluation that may be required.
Related guide: Medical Device Approval Process in Japan · For application support: Approval, Certification & Notification Support
Contact us about the approval application category