Handling of Application for Marketing Certification of Medical Device Software in Japan

1. Overview

The Handling of Application for Marketing Certification of Medical Device Software (PFSB/MDRMPE Notification No. 1125-6, November 25, 2014) provides specific guidance for applicants seeking marketing certification for to-be-certified medical device software or storage media containing such software under the Pharmaceuticals and Medical Devices Act (PMD Act). It clarifies requirements related to application content, accessory functions, essential standards, and transitional provisions. (pmda.go.jp)

2. Application Requirements

For marketing certification of medical device software or storage media containing it (hereinafter “to-be-certified medical device software”):

• Submissions should follow the general Medical Device Marketing Certification Application procedures and the Points to Consider for Application documents referenced in the notification. (pmda.go.jp)
• Applicants must explain substantial equivalency with existing approved or certified products that include equivalent medical device software (“Existing Products”). (pmda.go.jp)
• Conformity to Japanese Industrial Standards (JIS) or International Electrotechnical Commission (IEC) standards included in the certification standards may not need to be presented if they are not applicable to the software concerned. (pmda.go.jp)

3. Accessory Functions

Accessory functions of the software are acceptable only if they are accessory features of the to-be-certified medical device software, similar to Existing Products. In the application form, accessory functions must fall within the descriptions of the relevant product functions in the existing product’s certification form. The intended use must be appropriately described based on generic name definitions, and functions not yet subject to certification should not be described. (pmda.go.jp)

4. Conformity with Standards for Essential Requirements

The conformity status of the to-be-certified medical device software with the Standards for Essential Requirements is assessed using a conformity checklist derived from medical device software checklists and the relevant Ministerial Notification concerning Standards for Essential Requirements. The checklist ensures that the software meets essential safety and performance requirements for medical devices. (pmda.go.jp)

5. Scope of Certified Certification Body Activities

Activities related to conformity certification reviews of to-be-certified medical device software are categorized in relevant notifications covering third-party certification bodies. The categories of activities should be those of medical devices whose software functions are comparable to those in question. (pmda.go.jp)

6. Transitional Measures

Parties marketing to-be-certified medical device software at the time of enforcement of the Amending Act are required to submit marketing certification applications within three (3) months of the effective date. They may continue to market/distribute the products until certification status is determined. This transitional treatment ensures continuity of distribution while applications are under review. (pmda.go.jp)

7. Conclusion

This notification details regulatory expectations for marketing certification applications specific to medical device software. It clarifies how to demonstrate equivalency with existing products, handle accessory functions, conform to essential safety standards, and apply transitional measures to products already on the market. (pmda.go.jp)