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.
Role of Registered Certification Bodies (RCBs)
RCBs are third-party entities accredited by the MHLW to review and certify medical devices under the Ninsho pathway. They play a crucial role in:
Certification Review: Evaluating the device against JIS standards.
QMS Audit: Conducting a Quality Management System (QMS) audit of the manufacturer’s facility to ensure compliance with Ordinance 169.
QMS Requirements for Ninsho Certification
Manufacturers must comply with QMS requirements defined under Ordinance 169. The MAH or DMAH submits the application to the RCB, which then performs a detailed QMS inspection. Certification is granted upon satisfactory implementation of the QMS.
Ninsho Registration Process
Device Classification and Preparation: Determine the classification of the device and ensure it meets the JIS standards applicable to the Ninsho pathway.
Appointment of MAH/DMAH: Designate either a Marketing Authorization Holder (MAH) or a Designated Marketing Authorization Holder (DMAH) as your representative in JApan
Technical Document Compilation: Prepare and submit the required technical documentation.
Appointment of RCB: Select and engage an RCB for the certification process. The RCB will review the device's compliance with JIS standards.
Documentation Submission: Submit the required documentation to the RCB. This includes technical data, risk analysis, manufacturing processes, and labeling information.
Technical Review and QMS Audit: The RCB will review the documentation and conduct a QMS audit.
QMS Inspection: The RCB will perform a Quality Management System (QMS) audit of the manufacturing facility to ensure compliance with relevant standards.
Certification Issuance: Upon successful review and audit, the RCB will issue a Ninsho certificate. This certification confirms that the device meets Japanese regulatory requirements and can be marketed in Japan.
Post-Market Surveillance: After certification, the device must undergo ongoing post-market surveillance to ensure continued compliance with safety and efficacy standards.
Timeline for Ninsho Certification
The timelines for certification can differ depending on the RCB. Ninsho certification process typically takes three to five months, covering technical evaluation, QMS audit, and certificate issuance.
Renewal and Expiration
Ninsho certification itself does not expire, but manufacturers are required to renew their Quality Management System (QMS) certificates every five years.. Regular updates and compliance checks are crucial to maintaining market access in Japan.
The Ninsho pathway provides a structured and efficient route for bringing medical devices to the Japanese market, especially for those that conform to JIS standards. By understanding and following the Ninsho requirements, manufacturers can streamline their entry into one of the world’s most lucrative healthcare markets.
Navigating Japan’s regulatory landscape can be complex, but with the right preparation and support, the opportunities are substantial. If you need assistance with the Ninsho pathway or other regulatory requirements in Japan, don’t hesitate to reach out to us.
For more detailed guidance on navigating Japan's medical device regulations, contact Artixio at info@artixio.com. We are here to support your success in the Japanese market.