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Resource Library for Medical Device Professionals

17 total results. Show all resources.

Japan's New QMS Conformity Assessment System

In this white paper, we discuss quality system assessment under Japan's new regulation, the Pharmaceutical and Medical Device Act.

8 pages
Oct 12, 2016

In Depth: Japan Medical Device Approval and Compliance

This video series about Japan's medical device market shows you the process and identifies the key concepts to know before you begin.

17 minutes
Apr 4, 2012
Download Regulatory Process for Medical Devices in Japan

Japan Regulatory Approval Process for Medical Devices

This chart illustrates the steps in Japan's PMDA medical device approval process and includes a timeline of expected approval.

2 pages
Aug 29, 2013

Introduction to Japan's Medical Device Approval Process

This video about Japan's medical device market gives an overview of the regulatory framework and registration process basics.

4 minutes
Jul 24, 2014

Japan's Pharmaceutical and Medical Devices Act (PMD Act)

In this white paper, we discuss how to register a medical device for sale in Japan as a foreign company and requirements to be aware of.

6 pages
Oct 10, 2016

Medical Device Consulting Services for Japan

Interested in selling your medical device or IVD in Japan? Emergo offers a wide range of regulatory, representation, QA and other services for companies looking to enter this market.

May 19, 2008
Watch our recent webinar on Medical Device Approval in Japan

WATCH NOW: Japan's Medical Device Approval Process

Learn about the most complex aspects of the Japanese medical device registration process from EMERGO's VP of Business Development.

47 minutes
Oct 13, 2016

What To Expect From Your Regulatory Representative

Are you planning to export your device to other medical device markets? Most countries require you to have a physical presence in that market. If you do not have an office there, you can appoint an independent representative to meet this need.

7 min
Nov 22, 2016
Fill out our short form to request information about Japan

Get smart about Japan in 1 hour

Thinking about entering the Japanese market for the first time? Understanding the PMDA regulatory requirements can be overwhelming and confusing. We assembled a packet that includes the basic information you need before deciding to enter this market.

1 page
Jun 5, 2017

Medical Device Change Applications in Japan

In this white paper, we discuss when and how to notify Japan's PMDA about design changes to your device.

15 pages
Jun 21, 2018

Clinical Data Requirements in Japan

Determining the Japanese clinical data requirements for your device can be challenging. This paper explains PMDA clinical requirements.

8 pages
Jul 8, 2016

Japan PMDA - Pharmaceuticals and Medical Devices Agency

Learn about the regulatory structure in Japan and major medical device regulations.

1 page
Feb 11, 2014

Transitioning to Medical Device Single Audit Program (MDSAP) Compliance

In this white paper, we discuss the steps you should follow to achieve MDSAP certification.

8 pages
Jan 15, 2018
Learn about basic demographic and healthcare market data on Japan

JAPAN – Overview of medical device industry and healthcare statistics

A brief look at Japan's medical device market, including potential opportunities and obstacles for manufacturers.

1 web page
Aug 28, 2014
Compare the time, cost and complexity of getting regulatory approval for medical devices

Time, Cost and Complexity of Regulatory Approvals Worldwide

Use this interactive table to estimate how long it takes to gain approval in popular markets worldwide, along with associated costs.

Interactive Page
Aug 25, 2015
Learn about the Japanese PMDA regulations which apply to medical devices

Japan Medical Device Regulations

A comprehensive list of medical device regulations in Japan with links to the original documents.

Downloadable PDFs
May 12, 2008