Resource Library for Medical Device Professionals

16 total results. Show all resources.

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

White Paper | 8 pages

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

Video | 17 minutes

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.download

White Paper | 6 pages

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

Process Chart | 2 pages

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

Video | 4 minutes

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.view all

Service Overview | Varies

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

Webinar | 47 minutes

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.watch now

Video | 7 min

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.view all

Market Data | 1 page

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

White Paper | 8 pages

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

Device Regulation | Downloadable PDFs

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

Market Data | 1 page

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

White Paper | 8 pages

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

Market Data | 1 web page

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

Process Chart | Interactive Page

Read by 50,000+ device professionals worldwide. Stay updated on changes to global medical device regulations.view all