Overview

Japan’s medical device market is one of the biggest in the world, which is projected to grow steadily through 2020. Medical device companies interested in marketing their devices in Japan must abide by Japan's Pharmaceuticals and Medical Devices Act (PMDA). Japan has a clear-cut device classification system and depending on the device’s class the country offers different registration procedures such as:

  • Pre-market submission (Todokede): It applies to general Medical Devices (Class I) wherein manufacturers can file a pre-market submission (which is also known as Todokede) to the PMDA. This is a notification, and no review/assessment by the PMDA will be conducted.
  • Pre-market certification (Ninsho): It applies to Class II (and a limited number of Class III) devices which have an associated certification standard (JIS), are subject to pre-market certification, which is otherwise known as Ninsho in Japan. The process is like the European CE Marking process where reviews are outsourced to a third party like a Notified Body.
  • Pre-market approval (Shonin): It applies to Class II and III devices which have no specific certification standard are subject to the pre-market approval process, also known as Shonin. This also applies to all Class IV devices. In this case your MAH will file a pre-market approval application with the PMDA and ultimately obtain approval from the MHLW.

Despite having an established medical device Regulatory framework, navigating through Japan’s device classification system and respective registration procedures may require proven expertise.

Freyr, as a strategic Regulatory partner, provides end-to-end Medical Device Regulatory services that span across quality control, classification, clinical safety and market access. We assist clients in all the procedural challenges right from Regulatory intelligence to dossier preparation and submission to product registration.

Freyr Expertise

Quality

  • Quality Management System (QMS)
  • Good Quality Practice (GQP)
  • QMS application to PMDA
  • Preparation for PMDA inspection
  • Local product release
  • SOP writing
  • Quality manual writing
  • FMA application
  • Due diligence audits

Clinical

  • CRO oversight and management
  • Product development
  • In-country Caretaker (ICC) for clinical trials in Japan
  • Clinical trial notification (CTN)

Safety

  • Receipt, review and coding of adverse events
  • Safety Reports to PMDA
  • Good Vigilance Practice (GVP)
  • Post-marketing Surveillance (PMS) studies

Market access

  • Market-access, pricing, reimbursement strategies
  • Due-diligence and asset evaluation
  • Evidence-based portfolio prioritization
  • Review of Target Product Profile (TPP) and label claims
  • Evidence and economic needs assessment and evaluation
  • Distributor selection
  • Commercial and marketing strategies