PMDA review routes facilitating earlier marketing of innovative medical devices

In a PMDA statement from its chief executive, review routes facilitating earlier marketing of innovative medical devices are detailed.

The statement emphasises that one of the most significant roles of the PMDA is to establish a fit for purpose review process for the approval of medical devices. This means having a review process that can cope with medical devices which undergo repeated improvements and modifications post marketing e.g. devices which use artificial intelligence which are expected to change constantly. This ensures the quality, safety and efficacy of devices whilst providing patient access as quickly as possible, to innovative products.

In Japan, the regulation of medical devices varies according to the risks involved. Products are divided into three risk categories:

  1. Low risk products (Class I) – require prior marketing notification
  2. Medium risk product (Class II and some Class III) – require third party certification
  3. High risk products (some Class III and Class IV) – must obtain the minister’s approval through PMDA review

Since the establishment of the PMDA in 2004, it has enhanced and strengthened the capacity of reviewers of medical devices. In April 2021, a new review office was set up that specialises in software as a medical device (SaMD) using Artificial Intelligence etc. This will allow the PMDA to continue its efforts to speed up the approval review process for more advanced medical devices with greater medical needs.

Following the stepwise enforcement of the Pharmaceuticals and Medical Devices Act since Q3 2020, the predictability of the device review process has been improved even further due to the enforcement of the following new systems:

1. SAKIGAKE Medical Device Designation System

Medical devices that show potential for marked efficacy in the early phases of clinical trials are designated as SAKIGAKE (pioneering) Medical Devices, with the aim of accelerating regulatory approval. This is to facilitate patient access to innovative medical devices using breakthrough technologies ahead o the rest of the world.

Advantages of this system include prioritised consultation, enhanced pre-submission consultation and priority review, with a targeted review timeframe of 6 months.

2. Designation System for Medical Devices for Specific applications

Designated under this system are Medical devices used for the treatment of paediatric diseases with significantly unmet medical needs, offering outstanding value for use. Such devices can take advantage of priority review and other benefits of designation.

3. Conditional Early Approval System

This system allows for the approval of medical devices (with limited clinical data) that are particularly necessary for the treatment of:

  • serious diseases
  • diseases that lack effective treatments but for which it is difficult to conduct clinical studies for reasons such as rareness of the disease.

Approval is subject to conditions including the implementation of post-market risk management measures. In particular, PHOENIX (PHysical OpEratioN of Intelligible eXtrapolation approval) applies to medical devices that are designed to physically affect the human body, such as cauterization and irradiation, and for which there are clinical data for specific disease areas (e.g., organs, sites) that can be extrapolated to other areas.

4. Improvement Design within Approval for Timely Evaluation and Notice

For medical devices that undergo ongoing modifications and improvements during their post-market lifecycles, and AI-based programs and software whose performance is constantly changing and improving, change plans are confirmed during the approval review process so that partial amendments to approvals can be made promptly within the scope of such plans during the post-market lifecycle of a device.

As a form of regulatory agility during the COVID-19 pandemic, the PMDA is working to ensure that product development for COVID-19-related medical devices proceeds smoothly. This includes conducting priority reviews of such products and providing consultation for developers from the early stages of development.

Medical devices for fewer than 50,000 patients

In Japan devices in the above category are eligible for

  • research grants for promotion of research activities
  • preferential treatment such as tax exemptions.

Source: PMDA Japan website