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Medical Devices Regulatory Support in Japan

Overview

Japan is the second biggest market for medical devices and is expected to reach US$74.4 billion in sales by 2025. The medical devices registration process in Japan is governed by the Pharmaceuticals and Medical Devices Agency (PMDA), working under the Ministry of Health Labour and Welfare (MHLW), under the Pharmaceuticals and Medical Devices Act (PMD Act).

With exceptional knowledge of medical device Regulatory affairs in Japan & PMDA regulations, Freyr assists foreign manufacturers with medical device Regulatory support in Japan. To expedite your device’s Japan market entry, Freyr offers comprehensive Regulatory services right from Regulatory intelligence to dossier preparation and submission to device approvals.

Device Classification

For the registration of devices, it is very crucial to identify the category of the product, as the Regulatory approval process totally depends on that. Based on the Pharmaceuticals and Medical Devices Agency (PMDA) regulations, devices are classified as follows:

Device Class

Risk

Class I

Low Risk

Class II

Low/Medium Risk

Class III

Medium/High Risk

Class IV

High Risk

We, at Freyr Japan, help you identify the appropriate category, the respective Regulatory approval process, and the overall medical device Regulatory support in Japan.

Device Registration

According to the PMDA regulations, the registration pathway in Japan depends on various factors such as the medical device classification, the assigned Japan Medical Device Nomenclature (JMDN), the availability of predicate devices, and the availability of the associated Japanese Industrial Standard (JIS). The various device registration pathways in Japan are detailed below -

  • Pre-market Submission (Todokede): It applies to general medical devices (Class I), wherein manufacturers can file a premarket submission 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 that have an associated certification standard (JIS) and which are subject to pre-market certification. 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): Some Class II and III devices with no specific certification standard, and all the Class IV devices are subject to the pre-market approval process, also known as Shonin. This application must be submitted to the PMDA, and ultimately, approval is obtained from the MHLW.

We, at Freyr Japan, help you classify your device and choose the respective Regulatory approval process, strategic planning, and execution of market entry with our overall medical device Regulatory support in Japan.

Important Validities

Device approvals do not expire in Japan.

Frey Japan supports you with post-approval life cycle management of your product and with the overall medical device Regulatory affairs in Japan.

Freyr Expertise

  • Regulatory Due Diligence
  • Device Registration
  • Submission Management to the PMDA or the Notified Bodies
  • Data Reliability Inspection
  • QMS Inspection
  • Reimbursement Application Submission
  • Labeling Support
  • Distributor Identification and Qualification
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