Japan, with its advanced healthcare system and significant market potential, stands as a lucrative destination for medical device manufacturers. However, entering this market requires navigating a complex regulatory landscape. One of the primary pathways for medical device approval in Japan is the Shonin pathway. This blog provides a detailed overview of the Shonin pathway, its requirements, and best practices for successful registration.
What is the Shonin Pathway for Medical Device Registration in Japan?
The Shonin pathway is pre-market approval process for registation of medical devices and in vitro diagnostic (IVD) devices in Japan. This regulatory route is specifically used for Class II, Class III, and Class IV medical devices, particularly those that do not have an equivalent Japanese Medical Device Nomenclature (JMDN) code or for which there are no existing predicate devices in Japan. The Pharmaceuticals and Medical Devices Agency (PMDA) oversees this pathway, ensuring that devices meet the necessary safety and efficacy standards before they can be marketed.
Other Pathways for Medical Device Registration in Japan
Japan offers three primary pathways for medical device registration:
Shonin (Pre-Market Approval): For Class II, III, and IV devices that do not have existing Japanese standards or predicates.
Todokede (Pre-Market Submission): Used for Class I devices, requiring a pre-market notification to the PMDA. This pathway does not involve a detailed PMDA review.
Ninsho (Pre-Market Certification): Applicable to Class II and III devices that meet Japanese Industrial Standards (JIS). The Registered Certification Body (RCB) conducts the review and certification.
The choice of pathway depends on the device's risk classification and the availability of Japanese standards or predicates.
PMDA Classification of Medical Devices in Japan
Before diving into the Shonin pathway, it’s crucial to understand the classification of medical devices in Japan, as this determines the applicable regulatory requirements:
Class I: Extremely low-risk devices (e.g., scalpels, X-ray films)
Class II: Low-risk devices (e.g., ultrasonic devices)
Class III: Medium-risk devices (e.g., dialysis machines)
Class IV: High-risk devices (e.g., pacemakers, stent grafts)
The Shonin pathway primarily applies to Class II, III, and IV devices, with varying levels of scrutiny depending on the risk associated with the device.
Pre-requisites for Medical Device Registration under PMDA Shonin Pathway
To successfully register a medical device through the Shonin pathway, manufacturers must fulfill several prerequisites:
Submit General Device Data: Include comprehensive details about the device, such as its category, intended use, efficacy, risk analysis, and clinical data.
Provide Summary of Technical Documentation (STED): Prepare and submit a Summary of Technical Documentation in a standardized format.
Document Translation: All documents must be provided in Japanese. Ensure accurate translation to meet regulatory requirements.
Appoint a Marketing Authorization Holder (MAH) or Designated MAH (DMAH): Foreign manufacturers must appoint a local MAH or DMAH to manage the regulatory process.
Obtain Foreign Manufacturer Registration (FMR): Foreign manufacturers must register their manufacturing facilities with the PMDA to comply with Japanese regulations.
Document submission requirements for Shonin Pathway
When preparing a Shonin (Pre-Market Approval) submission in Japan, comprehensive and precise documentation is crucial to meet the Pharmaceuticals and Medical Devices Agency (PMDA) requirements. Here’s an overview of the essential information needed for a Shonin submission:
Cover Letter: A formal letter addressed to the PMDA, outlining the purpose of the submission and summarizing key details about the device and its intended use.
Application Form: Application Form 22-3 (Shonin Shinsei Syo) must be completed and submitted along with the Shonin application. It includes:
Category: Classification of the device according to its type and use.
Name: The device name as it will appear on the market.
Purpose of Use, Efficacy: The intended use of the device and its intended therapeutic or diagnostic efficacy.
Shape, Structure or Principle: Detailed description of the device’s physical form, structure, and underlying operational principles.
Raw Materials or Components: Information on the materials used in the device and their sources.
Specifications: Detailed technical specifications of the device, including dimensions, performance characteristics, and other critical parameters.
Operation for Use/Procedure: Instructions on how the device is to be used and the procedures for its operation.
Manufacturing Process: Description of the manufacturing process, including any steps critical to device safety and performance.
Storage or UBD: Information on how the device should be stored and its usable life or expiration date.
Site for Manufacturing: Details of the manufacturing facility where the device is produced.
Manufacturing Site for Raw Materials: Information about the facilities where raw materials are sourced and processed.
Remarks: Additional notes or documents such as the package insert and other relevant information.
The information must be submitted in GHTF-based STED document (Gaiyo) format.
Key Steps in the Registration of Medical Devices under Shonin Pathway
Determine Device Classification: Accurate classification of your device using the Japanese Medical Device Nomenclature (JMDN) codes is the first step. This classification will guide the regulatory requirements and submission process.
Appoint a Marketing Authorization Holder (MAH) / Designated MAH (DMAH): For foreign manufacturers, appointing a local Marketing Authorization Holder (MAH) or a Designated MAH (DMAH) is mandatory. The MAH/DMAH is responsible for managing the regulatory submission process and ensuring compliance with Japanese regulations.
Prepare Technical Documentation: Submit a comprehensive technical documentation package to the PMDA.
Quality Management System (QMS) Compliance: Compliance with Quality Management System (QMS) requirements is crucial for Shonin registration. Manufacturers must comply with the QMS requirements under Ordinance No. 169. The sponsor, MAH, or DMAH must apply to the PMDA. A QMS audit will be conducted by the PMDA or a Registered Certification Body (RCB) to verify compliance. Certification is issued upon satisfactory implementation of the QMS. Alternatively, MDSAP Certificate is also accepted by PMDA.
Submit Shonin Application: The Shonin application includes the technical documentation and proof of QMS compliance. The PMDA will review this submission to assess the device's safety and efficacy. This process typically takes 9 to 16 months.
Address PMDA Review Feedback: Be prepared to address any questions or requests for additional information from the PMDA. Timely and thorough responses are crucial for maintaining the review timeline.
Obtain Approval and Market Your Device: Upon successful review, the PMDA will issue an approval letter, allowing you to market your device in Japan. Ensure that you comply with all post-market surveillance requirements to maintain market authorization.
Key Considerations for Successful Shonin Registration
Documentation Accuracy: Ensure all technical documentation is comprehensive and accurate. Incomplete or incorrect submissions can lead to delays.
Language Requirements: All documentation must be in Japanese, so invest in professional translation services to avoid errors.
Quality Management: Implement a robust QMS and be prepared for thorough audits by the PMDA or RCB.
Local Representation: Choose a reliable MAH or DMAH with experience in navigating the Japanese regulatory landscape.
PMDA Timeline for Medical Device Registration under Shonin Pathway
PMDA Timelines: The PMDA generally requires about 12 months for technical assessment from the date of receiving the Shonin application. Manufacturers should factor in additional time for preparing submission documents and conducting clinical studies.
Expiration: While medical device registration itself does not expire, QMS certificates must be renewed every five years to maintain compliance.
The Shonin pathway is a critical route for gaining market access in Japan for Class II, III, and IV medical devices. By understanding and meticulously following the requirements, you can streamline the approval process and successfully enter one of the world's most advanced medical device markets. If you need expert guidance or support with the Shonin pathway, consider partnering with experienced regulatory consultants to navigate the complexities and ensure a smooth approval process.
For personalized assistance with your medical device registration in Japan, contact us at info@artixio.com. We’re here to help you achieve regulatory success and tap into the Japanese market with confidence.
References :
Comments