Japan's medical device market is a significant and lucrative arena, but accessing it involves understanding and adhering to a complex regulatory framework. Among the various pathways for medical device approval in Japan, the Todokede pathway is specifically tailored for certain medical devices. This blog provides an in-depth look at the Todokede pathway, its requirements, and how it fits into Japan's broader regulatory landscape.
What is PMDA Todokede Pathway in Japan ?
Todokede, also known as Pre-Market Submission, is a regulatory pathway for medical devices in Japan. This pathway is used for Class I devices, which are considered low-risk and do not require extensive pre-market review. Under Todokede, manufacturers submit a pre-market notification to the Pharmaceuticals and Medical Devices Agency (PMDA) to ensure their devices comply with Japanese regulations before they can be marketed.
Other Pathways for Medical Device Registration in Japan
Japan offers three primary pathways for medical device approval:
Todokede (Pre-Market Submission): For Class I devices. This pathway involves submitting a notification to the PMDA for approval.
Ninsho (Pre-Market Certification): For Class II and certain Class III devices with Japan Industrial Standards (JIS). The Registered Certification Body (RCB) is responsible for reviewing and certifying these devices.
Shonin (Pre-Market Approval): For high-risk Class II and III devices and Class IV devices. This pathway requires submission to the PMDA, which conducts a comprehensive review.
Todokede is specifically used for Class I devices, allowing for a simpler and faster registration process compared to other pathways like Shonin and Ninsho, which are used for higher-risk devices.
Prerequisites for Medical Device Registration in Japan under PMDA Todokede Submission
For a successful Todokede submission, manufacturers must fulfill several key requirements:
Device Classification: Ensure that the device qualifies as a Class I medical device under Japanese regulations.
Pre-Market Notification: Prepare and submit a Todokede notification to the PMDA. This document includes basic information about the device and its intended use.
Compliance with Japanese Standards: Ensure the device complies with relevant Japanese standards and regulations applicable to Class I devices.
Documentation: Provide required information in Japanese.
QMS Requirement: Unlike higher-risk pathways, Todokede does not require a formal Quality Management System (QMS) certification or audit.
Submission Process for Medical Device Registration in Japan under PMDA Todokede Submission
The Todokede submission process involves several steps:
Device Classification: Confirm that the device is classified as Class I and falls under the Todokede pathway.
Preparation of Documentation: Compile necessary documents, including device specifications, intended use, and compliance with Japanese regulations.
Appointment of MAH: A Market Authorization Holder (MAH) must be appointed in Japan to handle the registration process for Class I devices.
Foreign Manufacturer Registration (FMR): If the manufacturer is foreign, they must submit a Foreign Manufacturer Registration (FMR) to the Pharmaceuticals and Medical Devices Agency (PMDA).
Quality Management System (QMS) Certification: While most Class I devices do not require Quality Management System (QMS) certification, some may need it.
Local Language Documentation: All documents submitted to the PMDA must be in Japanese. The MAH must ensure compliance with this requirement.
Submission to PMDA: Submit the Todokede notification to the PMDA, including all required documentation.
Review by PMDA:The process involves self-certification and does not require PMDA review or assessment. Approval is typically granted within a month.
Timeline for Todokede Submission
The Todokede process is generally quicker than other regulatory pathways. Manufacturers can expect the review process within a month, depending on the completeness and accuracy of the submission. Since this pathway is for low-risk devices, the timeline is relatively short compared to the Shonin and Ninsho pathways.
Expiration and Renewal
The Todokede pathway does not have an expiration timeline for device registration. However, manufacturers must ensure ongoing compliance with Japanese regulations and standards. Changes to the device or its intended use may require a new Todokede submission or additional notification.
Benefits of the Todokede Pathway
Efficiency: The Todokede process is fast, typically taking less than one month for processing.
Simplicity: The process allows for self-certification, removing the need for a formal review by the PMDA.
Cost-Effective: Compared to other pathways, Todokede is less costly and administratively burdensome.
Japan's medical device market presents significant opportunities, but navigating the regulatory landscape is crucial for successful market entry. The Todokede pathway offers a streamlined process for Class I devices, making it an attractive option for manufacturers of low-risk devices. By understanding and adhering to the requirements of the Todokede pathway, manufacturers can efficiently bring their devices to the Japanese market.
For comprehensive guidance on navigating Japan's regulatory pathways, consider partnering with a regulatory expert who can provide tailored support and ensure compliance with all relevant standards and requirements.
Ready to Take Your Medical Device to the Japanese Market?
Contact us at info@artixio.com to learn more about how Artixio can assist you with the Todokede pathway and other regulatory needs. Let us help you make your market entry into Japan smooth and successful.
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