Japan, with its sophisticated healthcare system and significant market potential, presents a lucrative opportunity for medical device manufacturers. However, entering this market requires navigating complex regulatory pathways. One key route for registration of medical device in Japan is the PMDA's Ninsho pathway, a certification system designed to streamline the approval of specific medical devices. This blog delves into the Ninsho pathway, highlighting its process, requirements, and the role it plays within Japan's broader regulatory framework.
What is the Ninsho Pathway?
The Ninsho (Pre-Market Certification) pathway is one of the three main routes for medical device registration in Japan. It is primarily used for Class II and certain Class III medical devices that conform to Japanese Industrial Standards (JIS). Ninsho is a third-party certification system used in Japan for medical devices. Under the Ninsho pathway, devices must be certified by a Registered Certification Body (RCB) accredited by the Ministry of Health, Labour, and Welfare (MHLW). The Ninsho pathway is applicable to Class II devices and a select number of Class III devices that have established JIS criteria. Notably, some Class II devices without specific certification criteria are processed through the Shonin pathway instead
Key Features of the Ninsho Pathway
Applicable Device Classes:
Class II Devices: Generally low to moderate risk devices that have established certification criteria.
Class III Devices: Some devices in this category, especially those with JIS standards, can also use the Ninsho pathway.
Certification Body Involvement: Devices undergoing the Ninsho pathway must be reviewed and certified by an RCB. These bodies are responsible for ensuring that the device meets the relevant JIS standards and regulatory requirements.
Document Requirements: The application for Ninsho certification includes detailed technical documentation and evidence that the device conforms to JIS standards.
Prerequisites for Ninsho Registration
To successfully navigate the Ninsho pathway, manufacturers must ensure the following:
Device Classification and Standard Compliance: Confirm that the device is classified correctly and verify that it complies with the relevant JIS standards.
Selection of an RCB: Choose a Registered Certification Body (RCB) accredited by the MHLW. The RCB will conduct a thorough review of the device and its compliance with JIS standards.
Submission of Documentation: Prepare and submit comprehensive documentation, including:
Device Category and Purpose of Use
Efficacy and Risk Analysis
Specifications and Manufacturing Process
Quality Management System (QMS) Documentation
Package Insert and Labeling Requirements
Language Requirements: All documentation must be provided in Japanese. This includes technical documentation, user manuals, and any other relevant materials.
Appointment of MAH/DMAH: Foreign manufacturers must appoint a Marketing Authorization Holder (MAH) or a Designated Marketing Authorization Holder (DMAH) in Japan. This entity will act as the point of contact with the Japanese regulatory authorities.
