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)|
Regenerative Medicine Products
|Review for Shonin (Approval)|
|Review for Partial Change of Existing Shonin (Approval)|
|Document-Based Conformity Inspection|
Japanese medical device manufacturers may find a list of user fees for PMDA and MHLW activities by visiting the following online resources:
- Medical Devices & IVDs (published 01 April 2018)
- Regenerative Medicine Products (published 01 April 2018)
- MHLW QMS Fee Calculation Spreadsheet (published 01 January 2018)
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:
- Focus on Japan Series:
- Part I: Important Factors for Medical Device Development in Japan
- Part II: Understanding the Designated Marketing Authorization (D-MAH) Status for Foreign Device Manufacturers
- Part III: Registering Facilities Under Foreign Manufacturer Accreditation (FMA)
- Part IV: Streamlining the Quality Management Approval Process
- The Three Pathways to Medical Device Registration in Japan
- Japan’s “Ninsho Kijun” Regulatory Approval Pathway
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 firstname.lastname@example.org if you would like to discuss how to successfully navigate the Japanese medical device marketplace – let our regulatory expertise help with your product success!
Leah Davidson, MA, MBA
Leah has been with NAMSA since 2016 and currently serves as Senior Manager of Global Marketing Communications. She possesses 20 years' experience within the medical device, healthcare technology and non-profit industries and has worked in various marketing and communications capacities throughout her career. In her role at NAMSA, she is responsible for the development and implementation of brand strategies and marketing communications initiatives that help drive the organization's sales and organizational growth goals globally.