Japan’s PMDA to Raise Medical Device and IVD Registration User Fees Beginning April 2018

In Asian Market, Consulting, Regulatory by Kei Yoshikawa

On 31 January 2018, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) released Cabinet Order No. 24 which sets forth changes for medical device and IVD registration user fees. These changes, which include increases from 8 to 15 percent, are effective 01 April 2018.

To assist medical device manufacturers in assessing the impact of these changes to their organizations, a comparison table was issued by the Ministry of Health, Labour and Welfare (MHLW) within the notification PSEHB No. 0131-3, found here.

Eight categories are subject to change under Cabinet Order No. 24 as follows:

Medical Devices & IVDs

Review for “Shonin” (Approval)
Review for Partial Change of Existing “Shonin” (Approval)
Conformity Inspection
User-Result Surveillance

Regenerative Medicine Products

Review for Shonin (Approval)
Review for Partial Change of Existing Shonin (Approval)
Document-Based Conformity Inspection
Re-Examination

Additional Resources
Japanese medical device manufacturers may find a list of user fees for PMDA and MHLW activities by visiting the following online resources:

  1. Medical Devices & IVDs (published 01 April 2018)
    https://web.fd-shinsei.go.jp/application/list_device2.html 
  2. Regenerative Medicine Products (published 01 April 2018)
    https://web.fd-shinsei.go.jp/application/list_regenera2.html 
  3. MHLW QMS Fee Calculation Spreadsheet (published 01 January 2018)
    https://web.fd-shinsei.go.jp/download/qmscalc/index.html

Medical Device Registration Pathways in Japan
For further information regarding Japanese registration pathways, NAMSA has developed various blog posts to provide a deeper understanding of registration requirements:


NAMSA Can Help
Medical device and IVD registration applicants must carefully consider which approval pathways are most appropriate when trying to achieve accelerated and cost-efficient product development within the Japanese marketplace. NAMSA, the world’s only Medical Research Organization (MRO), provides global medical device organizations regulatory consulting services to assist in identifying the best-fit get-to-market strategy to achieve successful product introduction and commercialization.

Examples of services provided are:

  • Regulatory assessment
  • Gap analysis
  • Global regulatory strategy development
  • Pre-IDE meeting preparation, including development of pre-meeting packet
  • Pre-IDE meeting participation
  • Pre-market submissions: 510(k), PMA, BLA, HDE
  • FDA inspection preparation
  • FDA advisory panel preparation and meeting support

Please contact us at communications@namsa.com if you would like to discuss how to successfully navigate the Japanese medical device marketplace – let our regulatory expertise help with your product success!

We also invite you to visit our recently-released Japanese website by clicking here or directly going to http://namsa.co.jp/.

Authors:

Kei Yoshikawa serves as Medical Research Manager at NAMSA's Japan location.