Japan
Medical Device Registration
The medical device market in Japan is one of the largest in the world, and it is regulated by the Pharmaceuticals and Medical Devices Agency (PMDA). The registration process involves preparing necessary documents, submitting applications, and paying required fees. This process is guided by the Pharmaceutical and Medical Device Law (PMDL), which has undergone several revisions, the most recent one being in 2014.
Navigating the regulatory landscape in Japan can be a complex task. The cost and timelines are not set in stone and can fluctuate based on the device’s classification and the existence of predicates (The predicate system or the Japan Medical Device Nomenclature Code (JMDN code) system).
The Marketing Authorization Holder (MAH) of the device must ensure its efficacy, safety, and quality based on evidence before submission. It’s important to stay updated with the latest changes in the registration process for success in this highly regulated market.
Classification and Pathways
| Classification | Risk Level | Description | In JP | Registration Pathway | Fees |
|---|---|---|---|---|---|
| Class I | Extremely Low Risk | These devices require notification to the PMDA | 一般的な医療機器 (General Medical Devices) | Pre-market Submission (Todokede) | ¥0 ($0) |
| Class II | Low Risk | Devices in this class require certification by a registered certification body if certification standards exist. Other Class II devices require approval of the MHLW. | 管制医療機器 (Controlled Medical Devices) | Pre-market Certification (Ninsho) for devices with a specific certification standard. Pre-market Approval (Shonin) for devices without a specific certification standard. | PMC: ¥500,000 ($3,378) PMA: up to ¥8,620,500 ($58,247) |
| Class III | Medium Risk | Devices in this class require certification by a registered certification body if certification standards exist. Other Class III devices require approval of the MHLW. | 特に管理された医療機器 (Specially Controlled Medical Devices) | Pre-market Certification (Ninsho) for devices with a specific certification standard. Pre-market Approval (Shonin) for devices without a specific certification standard. | PMC: ¥500,000 ($3,378) PMA: up to ¥8,620,500 ($58,247) |
| Class IV | High Risk | These devices require approval of the MHLW | 高度に管理された医療機器 (Highly Controlled Medical Devices) | Pre-market Approval (Shonin) | Up to ¥11,736,000 ($79,297) |
Process of Different Pathways
Pre-market Submission (Todokede)
The Todokede is a pre-market submission procedure used for registering Class I (low-risk) medical devices in Japan. This process is overseen by the Pharmaceuticals and Medical Devices Agency (PMDA).
Applications for Todokede are submitted to the PMDA and are considered accepted upon submission. These applications are exempt from the quality systems conformity certification requirement.
The timeline for the Pre-market Submission (Todokede) process in Japan is relatively short compared to other processes. Once the necessary documentation is in place, it takes less than one month for processing. 
Pre-market Certification (Ninsho)
The PMC process is applicable to most Class II (medium risk) and some Class III (high risk) devices that have an associated certification standard. The review of the medical device and quality systems conformity assessments are outsourced to Registered Certification Bodies (RCB). This process is similar to the European CE Marking process where reviews are outsourced to a third party similar to a Notified Body.
The average time to process a PMC application is approximately 3 months. 
Pre-market Approval (Shonin)
The PMA process, also known as ‘Shonin’, is a critical regulatory pathway in Japan for new Class II, Class III, and all Class IV devices. This process is overseen by the Pharmaceuticals and Medical Devices Agency (PMDA), and it involves a thorough review of the medical device’s safety and effectiveness.
The timeline for the PMA process can vary significantly depending on the device’s classification and the requirements for clinical evidence. On average, the PMA process can take anywhere from 6 months to 36 months.
Please note that this is a simplified overview and the actual process may involve more detailed steps and requirements. Always consult with a regulatory expert like Accel for the most accurate information. 
Partner with Accel Groups
Experience the Ease of Medical Device and IVD Registration in Japan with Our Expert Services! Navigating the regulatory landscape for medical devices and IVDs in Japan can be complex and time-consuming. But with our expert services, we make it simple and efficient. We have a deep understanding of the PMDA processes and the Ministry of Health, Labor and Welfare (MHLW) requirements. Whether your device falls under Pre-market Certification (Ninsho), Pre-market Approval (Shonin), or Pre-market Submission (Todokede), we’ve got you covered. Our team of regulatory experts ensures that your applications are accurately prepared and promptly submitted, saving you valuable time and resources. Plus, our post-market surveillance support ensures you stay compliant even after your device hits the market. Partner with us and experience a hassle-free journey to medical device and IVD registration in Japan!
Our Expertise
Our team of subject matter experts cover your complete product life cycle needs across key geographies from preclinical discovery, product design and validation documentation, QMS regulatory affairs, clinical research, QMS/GMP and cybersecurity etc. We are here to accelerate your key countries market access with one-stop solution.
