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.
