Certification vs Approval for Medical Devices in Japan
Whether a medical device follows the third-party certification route or the marketing approval route cannot be determined by its class alone. The decision requires confirmation of the generic name, availability of a certification standard, the scope of that standard, and the product's intended use and specifications.
Check Whether the Product Falls Within the Scope of a Certification Standard
Third-party certification is a system under which a Registered Certification Body (RCB) certifies individual medical devices designated by the Minister of Health, Labour and Welfare for which certification standards have been established. To qualify for certification, an applicable certification standard must exist and the product must fall within its scope.
If no certification standard exists, or if the intended use, specifications, or other characteristics fall outside the scope of the standard, the marketing approval route should be considered. For approval applications, PMDA reviews quality, efficacy, and safety, and the Minister of Health, Labour and Welfare grants approval.
It is therefore not always correct to assume that "Class II means certification" or "Class III means approval." The product's generic name and the applicable certification standard should be checked against its actual specifications.
Comparison of Third-Party Certification and Marketing Approval
Registered Certification Body (RCB) registered by the Minister of Health, Labour and Welfare
PMDA conducts the review and the Minister of Health, Labour and Welfare grants approval
Designated specially controlled medical devices, designated controlled medical devices, and other products for which a certification standard has been established and whose scope applies
Medical devices that are not eligible for certification and require marketing approval
Conformity with the applicable certification standard
Product-specific review of quality, efficacy, and safety
Technical documentation demonstrating conformity with the certification standard, Essential Principles, and relevant standards
Application form, STED, test data, clinical evaluation documentation, and other materials according to the application category and product characteristics
QMS conformity is confirmed together with the certification application
QMS conformity inspection is handled in parallel with the approval review
The Registered Certification Body to which the application is planned
Consider use of PMDA's consultation services
Items to Check When Determining the Application Route
Confirm the applicable generic name based on intended use, structure and principle, and risk.
Confirm whether the product is a general, controlled, or specially controlled medical device.
Confirm whether a certification standard has been established for the applicable generic name.
Confirm whether the intended use, performance, structure, materials, and other characteristics fall within the scope of the certification standard.
Compare similarities and differences with reference products to determine the required evaluations and application route.
Also review how planned post-application specification changes may affect labeling, manufacturing sites, and post-market obligations.
From Product Information to Selection of the Application Route
- 01
Confirm Product Information and the Generic Name
Confirm the intended use, target patients, structure and principle, specifications, materials, accessories, and method of use, and identify candidate generic names.
- 02
Confirm the Class, Certification Standard, and Scope
Confirm the JMDN code and class, whether a certification standard exists, and any provisos or limitations in its scope.
- 03
Evaluate Differences from Certified and Approved Products
Assess how differences from existing certified or approved products may affect performance, safety, and clinical evaluation.
- 04
Decide Between Certification and Approval
For certification, confirm an RCB whose certification scope covers the product. For approval, confirm the application category and whether PMDA consultation should be used.
Official Information on the Registered Certification Body System
PMDA provides information on products eligible for third-party certification, Registered Certification Bodies, and the certification scope of each body.
Supporting Documentation Is Required Under Either Route
For certification applications, technical documentation is submitted mainly to demonstrate conformity with the certification standard and Essential Principles, including documentation concerning performance, safety, manufacturing, and labeling. It is also necessary to confirm whether the standards and test methods used to demonstrate conformity are appropriate for the product.
For approval applications, the application is explained using comparison with approved products, performance and safety testing, clinical evaluation, STED, and other documentation according to the application category and product characteristics. The greater the novelty or differences of the product, the more important it becomes to provide documentation supporting the impact of those differences.
- Intended use, shape and structure, principle, and method of use
- Specifications, performance, test methods, and acceptance criteria
- Risk management and conformity with the Essential Principles
- Biological safety, electrical safety, sterilization, packaging, and other relevant evaluations
- Labeling, package insert, and precautions for use
- QMS and information on manufacturing sites and manufacturing processes
Points Commonly Overlooked When Selecting the Route
- Assuming that the class alone determines eligibility for certification
- Checking only the name of a certification standard without reviewing its scope or provisos
- Failing to notice that the intended use or performance falls outside the certification standard
- Selecting a generic name that does not sufficiently correspond to the product's structure or principle
- Failing to confirm the certification scope of the selected RCB
- Failing to assess how planned specification changes may affect the certification standard or application route
Application Route Assessment and Support by MK Consulting K.K.
Based on the product information, we review the generic name, class, certification standard, and scope and organize the likely application route. We also support preparation of the technical documentation required for certification or approval and responses to inquiries from RCBs or PMDA.
Frequently Asked Questions About Certification and Approval
Does Every Class II Device Follow the Third-Party Certification Route?
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No. Even for a Class II device, marketing approval may be required if no applicable certification standard exists or the product falls outside the scope of the standard. The route cannot be determined by class alone.
Can a Class III Device Be Eligible for Certification?
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Yes. Certain specially controlled medical devices designated by the Minister of Health, Labour and Welfare for which standards have been established may be eligible for third-party certification. Check the latest generic name and certification standard information.
Are All Registered Certification Bodies the Same?
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No. The scope of certification services differs among RCBs. Confirm whether the body can handle the target product, as well as its application documentation requirements, process, and language support.
Is PMDA Completely Uninvolved in a Certification Application?
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The product certification review itself is performed by the RCB. However, PMDA and the Ministry of Health, Labour and Welfare remain involved in the broader medical device regulatory system, including public information on generic names, QMS, and safety measures.
Can Product Specifications Be Changed After Certification?
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Depending on the change, a change certification, notification, or no regulatory procedure may be appropriate. Review the impact on intended use, performance, safety, conformity with the certification standard, and QMS before implementing the change.
Related guides: Medical Device Classification in Japan | How to Check Medical Device Certification Standards in Japan
You Can Contact Us Even If You Have Not Yet Determined Whether Certification or Approval Applies
Share the intended use, main specifications and any application pathway under consideration. You can contact us before the pathway is decided.
Contact us about the application route