When applying for medical device approval or certification in Japan, the tests required depend on the individual product.
Medical devices may need evaluation of biological safety, performance, mechanical safety, electrical safety, EMC, sterilization, packaging, durability, software and other areas, but not every product requires every test.
The required evidence should be determined after reviewing the intended use, Japanese generic name, classification, regulatory pathway, differences from approved products, applicable standards and risk management.
For this reason, the correct approach is not to start testing first. It is to identify what must be demonstrated and then build the test plan around that requirement.
The evidence needed to demonstrate safety and performance differs significantly by product.
For example, devices that contact the patient may require biological safety evaluation, while electrically powered devices may need assessment of electrical safety and electromagnetic compatibility (EMC).
Sterile devices may require evidence relating to sterilization, sterility assurance, packaging and shelf life.
Devices that include software may also require evaluation of the software life cycle, risk management and cybersecurity.
The key point is not to select tests mechanically from a checklist. The required evaluations should be determined based on what evidence is needed to demonstrate the safety and performance of the specific device.
First, define the intended purpose of the device, the patient population, the clinical setting and the conditions of use.
Even devices with similar structures may require different evaluations if their intended use, contact site, duration of use, user or use environment differs.
Confirm the Japanese generic name, JMDN code and risk classification, and determine whether the product follows notification, certification by a Registered Certification Body, or marketing approval with PMDA review.
The existence of applicable certification or approval standards should also be checked.
If similar products are already approved or certified in Japan, identify the differences.
Examples include:
The greater the difference, the more likely it is that additional testing or documentation may be needed to justify the change.
Medical devices must be assessed for conformity with Japan's Essential Principles.
For each applicable requirement, determine how conformity will be demonstrated through standards, testing, design documentation, risk management records or other evidence.
Testing is one way to demonstrate conformity.
When using JIS, ISO or IEC standards, confirm:
This is especially important when overseas testing has already been completed.
Performance testing confirms that the medical device can achieve its intended performance.
The specific tests depend on the device.
For catheters and endoscopic accessories, examples may include:
These are only examples and are not required for every device.
The test plan should be based on the performance specifications claimed in the Japanese application and the actual clinical use of the device.
Depending on the materials and product characteristics, physical and chemical evaluation may be needed.
Examples include:
If the materials or manufacturing process differ from an approved device, the impact of those differences on safety and performance should be evaluated.
For devices that contact patients or users, biological safety should be evaluated based on the contact site and duration, materials, manufacturing processes, sterilization, and available data. ISO 10993 tests should not be selected mechanically; the necessary evaluation should be determined based on the risks of the specific device. For details, see “Biological Safety Evaluation of Medical Devices.”
Electrically powered medical devices may require evaluation of electrical safety and electromagnetic compatibility.
Depending on the product, JIS or international standards corresponding to IEC 60601-1 and IEC 60601-1-2 may be used.
Device-specific particular standards may also apply.
Therefore, completing IEC 60601-1 alone is not always sufficient. Applicable standards should be selected based on the device type, use environment, power source, connected equipment and wireless functions.
For devices supplied sterile, evidence may be needed to support the sterilization method and sterility assurance.
Japan has specific regulatory notices covering sterilization information for medical device approval and certification applications.
The required evidence differs depending on whether the method is ethylene oxide, radiation, moist heat or another process.
The assessment may also need to address the effects of sterilization on the device, residues, packaging and shelf life.
For sterile products or devices whose performance may change over time, evidence may be needed to justify packaging integrity and shelf life.
If storage conditions or shelf life are stated in the application, supporting evidence should be available.
Depending on the device, evaluation may include:
Accelerated aging may be used in some cases, but the appropriateness of the conditions and product-specific assumptions should be justified.
For medical devices containing software, the safety of the software and the design and development process may need to be documented.
Depending on the product, the software life-cycle process may be evaluated using IEC 62304 or related standards.
This applies not only to standalone software medical devices but also to embedded software when it can affect the safety or performance of the device.
Cybersecurity is an important consideration for devices that connect to networks, use wireless communication or exchange data with external systems.
Japan's Essential Principles include cybersecurity requirements, and devices with relevant cyber risks are expected to conform to the applicable requirements.
The necessary risk assessment and controls should be determined based on the connectivity architecture, software, communication methods and update mechanisms of the device.
Usability engineering may be needed where user interaction can affect safety.
JIS T 62366-1 is positioned in Japan as a key usability engineering standard.
If use error can create risk, the assessment should consider the intended users, use environment, operating sequence and user interface.
A Japanese marketing approval application does not automatically require a clinical trial.
In some cases, effectiveness and safety may be supported by non-clinical testing, existing clinical data, literature and comparison with approved devices.
However, a clinical trial may be needed where there is a new principle of operation, a new intended use, a major difference from approved products, or where non-clinical evidence alone cannot adequately support clinical safety and effectiveness.
PMDA also offers consultation categories for discussing whether a new clinical trial is necessary based on available non-clinical evidence.
Where uncertainty exists, this question should be addressed early in development rather than after the test program is complete.
Overseas test data may be usable in Japanese approval or certification applications.
However, the fact that a device has already been tested overseas does not automatically mean that the data can be used without further assessment.
Confirm:
PMDA reliability inspections review submitted test data for accuracy, completeness and preservation of supporting records.
For this reason, it is important to maintain not only summary results but also test plans, reports and supporting source records.
For overseas manufacturers, discovering the need for additional testing only after the Japanese submission project has started can have a major effect on the market-entry schedule.
A more efficient approach is to inventory existing test reports first and perform a gap assessment against Japanese requirements before finalizing the Japan test plan.
Even a successful test may not be sufficient if the tested product does not adequately represent the product intended for the Japanese market.
Particular attention is needed when there have been changes in:
This does not mean that every test must automatically be repeated.
The change should be assessed for its effect on safety and performance, and a decision made as to whether the existing evidence remains applicable or additional testing is required.
A practical sequence is:
Intended use and product specifications → Japanese generic name and classification → Notification, certification or approval pathway → Certification standards, approval standards and applicable standards → Differences from approved products → Essential Principles and risk analysis → Review of existing test data → Identification of missing evidence and additional testing
This approach helps manufacturers make effective use of existing overseas data while focusing new testing on the actual evidence gaps for Japan.
If testing starts before the generic name, application category or certification standard is confirmed, the test methods or evaluation items may later prove insufficient.
The ISO or IEC edition used overseas may not match the edition referenced in the Japanese certification framework or expected for the current application.
Check both the standard number and its edition and scope.
Overseas regulatory documentation can be useful, but it needs to be organized to match the Japanese intended use, application form, Essential Principles and regulatory pathway.
Changes to materials, manufacturing processes, sterilization or software may affect the relevance of previous testing.
The impact of the change should be assessed before relying on existing evidence.
The reliability of test data is important in Japanese approval applications.
Test protocols, final reports and source records should be appropriately maintained.
For Japanese medical device applications, performing more tests is not the objective.
The objective is to prepare appropriate evidence of safety and performance based on the regulatory pathway and identified risks.
For foreign manufacturers, it is particularly important to review existing ISO and IEC testing, FDA documentation and CE marking or MDR documentation and distinguish between evidence that can be reused in Japan and evidence that is still missing.
MK Consulting K.K. reviews product specifications, existing test reports, overseas regulatory documentation and differences from approved products to identify the testing and evaluation items likely to be needed for Japan.
By considering the application strategy, PMDA consultation, test planning and STED preparation as one regulatory workstream before testing begins, unnecessary testing and rework can be reduced and Japan market entry can proceed more efficiently.
Not necessarily. Overseas test results may be usable.
The important points are whether the test article represents the Japanese product, whether the test method and standard are appropriate, and whether the reliability of the supporting records can be confirmed.
No. Biological safety evaluation should be planned on a risk-based basis considering the nature and duration of body contact, materials, manufacturing processes, sterilization and other relevant factors.
It depends on the device.
In addition to electrical safety, EMC, particular standards, wireless functions, software and the use environment may also need to be considered.
Potentially, but the test article must be shown to adequately represent the final product.
If there are differences in materials, structure, manufacturing process or sterilization, the impact of those differences should be assessed.
The decision should be made after determining how far non-clinical testing and existing evidence can support effectiveness and safety.
If the need remains unclear, PMDA consultation can be used at an early development stage.