Innovative Medical Device Registration in Japan

In 2019, Japan’s Ministry of Health, Labor and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) introduced a innovative device registration designation system meant to streamline the regulatory pathway for qualifying medical products. The Designation System, called Sakigake ( 先駆け), translates to “pioneer” or forerunner” to reflect the goal of  encouraging new technology to address unmet clinical needs. For medical device manufacturers with new devices, time-to-market and costs in Japan are daunting. The Sakigake program provides a significant reduction in the costs and time to register novel medical device technology in Japan.

Advantages of Sakigake

For Japan, the intent of the Sakigake program was to encourage a space for novel medical device development and in so doing has brought in investment and more research and development. Furthermore, Sakigake has reinforced Japan’s position as one of the global leaders in med-tech innovation.

Medical device manufacturers who think they may qualify for the Sakigake designation system can expect advantages such as:

1. Priority Review Process: If designated, the product(s) will receive prioritized consultations and accelerated reviews so as to shorten the time to market approval. Usually the consultation waiting period in Japan is 3+ months but via Sakigake it’s only 1 month and the regulatory application review time is reduced.
2. Early Dialogue and a Dedicated PMDA Manager: Sakigake fosters early and continuous dialogue between manufacturers and regulatory authorities. A PMDA review manager is assigned to the case and acts as a concierge all through PMDA and MHLW interactions.
3. Flexible Regulatory Requirements: Given that innovative products tend to pose challenges like a lack of certification standards or performance testing, Sakigake allows for more customized approaches in development and evaluation processes.
4. Post-Market Support: For ongoing safety and efficacy, the program lends support beyond just the approval stage.

Criteria for Sakigake Designation

Medical Devices, Regenerative Medical Products, and IVDs must meet all four of the designation criteria:

1. Novel Treatment or Diagnostic Method
   • The product must have a new principle in the case of a medical device, a new principle or a new measurement item in the case of an in vitro diagnostic product, or a new mechanism of action in the case of a regenerative medicine product.
2.  Severe Target Disease
   • Serious illness with life-threatening consequences.
   • Diseases for which there is no curative treatment and the symptoms (severe impact on quality of life) persist.
3. Extremely high efficacy or safety for the subject disease
   • No existing treatment exists.
   • Significant improvements in efficacy or safety as compared to existing treatments or diagnostic methods.
   Note: Medical devices for which efficacy can be  expected based on non-clinical studies but for which clinical trials should be conducted – the choice to include Japan
   in the study is desirable. When applying for approval of a medical device, etc. that requires a companion diagnostic agent, etc. for use, the applicant must have a system to apply for approval of said diagnostic agent, etc. at the same time.
4. Willingness and Infrastructure to support early development and submission for approval in Japan ahead of the rest of the world
   • The application will be filed in Japan prior to or at the same time as the application in the rest of the world (countries that have approval systems at the same level as Japan’s)
   • The application in the first country shall be counted as the starting date, and applications filed within 3 months from the same date shall be considered simultaneous applications).
   • The company must have infrastructure and resources to support the applications for approval and Q&A during the review period.

The designation system excludes products that have already been approved or those that would leverage existing device principles to expand indications.

Sakigake Application Process

The application process starts with a consultation and is followed by preparation of the electronic application for submission. The consultation process with the MHLW and PMDA is to confirm the eligibility of the product to use the Sakigake Designation System.

The electronic application is extensive and requires:

a. Documentation to support the mechanism/principle of action,
b. Documentation to support the medical necessity of the subject device,
c. Documentation and data on the severity and prevalence of the disease,
d. Documentation to support the current available similar medical devices and treatment methods,
e. [Optional] Summary of study results related to safety
f. Summary of Clinical Studies and Planned Clinical Studies
g. Summary of the applicability of the subject device to the eligibility criteria [Per “Overview of Applicability of Requirements for Designation of Pioneering Medical Devices” Form].

In order to submit the electronic application, a log-in must be created on the PMDA’s gateway system and the application submitted in PDF format. Designations are made twice a year, generally in April and October.

Our office in Japan are specialized in registering novel medical device technologies, contact us here to see if you may qualify for this program.