This is a quick summary of the December 14, 2022 Emergo Webinar presented by Kenji Yashiro on the topic: Medical Device Regulatory Requirements-Japanese Guidelines

Key Takeaways:

This blog will cover just a few high-level takeaways from the presentation by Kenji Yashiro, hosted by Emergo. While there is still no official timeline for Japanese UDI compliance, the presentation included some valuable information regarding guidelines for categorization and registration.

Categorization and Classification

The Pharmaceuticals and Medical Devices ACT (PMD Act) regulates businesses related to healthcare products such as in vitro diagnostics, medical devices, cosmetics and regenerative medicine products.

Unique to Japan, every healthcare product marketed in Japan must comply with the PMD Act.

The Ministry of Health, Labor, and Welfare (MHLW) is a central government agency in Japan similar to the FDA. The MHLW is responsible for enforcement of the PMD Act. Falling under the Ministry is the Pharmaceuticals and Med Devices Agency (PMDA). This group handles day-to-day tasks on behalf of the MHLW including reviewing applications and performing on site audits.

Registered Certification Bodies (RCB) offer 3rd party review similar to the 510(k) in the U.S.

The PMD Act divides healthcare products into six categories:

• Drugs
• IVDs
• Quasi-drugs
• Medical Devices
• Cosmetics
• Regenerative medicine products

Medical device classification in Japan is twofold:

• Device Class: Device Classes from Class I – Class IV
• Japan Medical Device Nomenclature (JMDN) Code. These codes are similar to GMDN but are not the same.

Identifying JMDN codes is the first step in regulatory compliance.

Registration Route

There are three registration routes:

• Pre-market notification (PMN)
• Pre-market certification (PMC)
• Pre-market approval (PMA

Class I products only require PMN registration, while PMC is required for Class II and Class III products. PMA is required of all products Class II – IV.

Class I SaMD is exempt from regulatory controls and does not require device registration.

Medical devices without an applicable JMDN will need to be subject to the PMA route.

More information about these registration routes can be found at https://www.emergobyul.com/.

Business Licenses – Marketing Authorization Holder License – MAH

This license allows entities to become legal manufacturers with the responsibilities for the release of medical devices into the Japanese market (Japanese entities only).

There are three types of MAH licenses:

• Type 1 (Class I – IV)
• Type 2 (Classes I and II)
• Type 3 (Class I)

To comply, the entity must hire three qualified managers to cover quality and safety as well as general responsibilities.

Not a Japanese entity? For global manufacturers that want to sell in Japan, there is the Specially Approval System for Foreign Manufactured Devices (SASF). The SASF requires foreign manufacturers to designate a MAH license holder as its local representative to delegate local QMS duties such as monitoring and reporting, measurement and analysis, and communication among every manufacturing establishment. This role will establish the management and implantation and release judgement of the products to the market.

This is a high-level overview of the in-depth presentation given by Kenji Yashiro for Emergo. The full presentation is available here.

Questions about health authorities and Unique Device Identification (UDI) submissions? We monitor health authorities around the globe for the latest requirements and exceptions. If you have UDI questions, we can help. Email us: [email protected] or call +1-215-557-3010