Regulatory Filing Requirements and Compliance Processes for medical devices in Japan

[John Robinson]

The market for medical devices in Japan is pretty huge. It ranks third in the world after the US and the EU. At just over $ 35 billion a year, which is characterized by an annual growth rate of 3-4 percent; it is far bigger than the markets in the neighborhood, such as China, Malaysia, Singapore and even Australia. Its market for medical devices is comparable to those of Europe and North America. Some of the reasons for this huge market are:

• The aging population
• The huge spending power of one of the world’s largest economies
• The infusion of new technologies into the field of medical devices, which pushes up costs initially
• The high proportion -nearly a quarter of the entire market -of imported medical devices, especially from the US, which introduce sophisticated, technology-driven products of higher price into the market

Japan’s classification system of medical devices, which classifies these products into Class I, Class II, Class III and Class IV; varies from that of the US or the EU. Adherence to Japanese Industrial Standards, which define industry-wide safety and performance requirements, is mandatory for medical devices.

In addition, the Japanese medical devices market has been undergoing a few major changes. Medical device manufacturers have to deal with strict new package insert requirements. The Marketing Authorization Holder (MAH) system, which deals with licensing rules, have changed, requiring a new MAH License category for In Vitro Diagnostic (IVD) devices. New changes have been made into several other aspects of medical devices. These include:

• The registration system for manufacturers
• QMS conformity assessment system
• Formats for pre-market certification and pre-market approval applications

Medical device manufacturers have to also reckon with expanded scope of third party certifications, and comply with rules for Software as a Medical Device and for transferring pre-market certifications.

Full explanation of the regulatory requirements 

All these factors make it very important for medical devices that want to enter the Japanese market, to get a thorough understanding of the regulatory requirements. Complete understanding of all these and more will be imparted at a two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance.

David R. Dills, Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the FDA regulated industry; will be the Director of this seminar. David carries an extensive regulatory and compliance background with Class I/II/III and IVD devices, pharmaceutical operations, and manages activities within the global regulatory and compliance arenas.

 

Please log on to Regulatory Filing Requirements and Compliance Processes for medical... to enroll for this highly valuable training session which will put the whole gamut of regulatory requirements for medical devices in Japan in perspective. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

 

Understanding how to streamline the regulatory process

By attending this seminar, participants will be able to get a proper grasp of the entire registration and approval process in Japan. They will be able to identify and understand the major changes to medical device registration process in Japan. This will help them to streamline the medical device registration process, which will help them to obtain approval for their product in the most cost-effective and timely manner.

 

At this highly interactive session, the Director will let participants discuss their own device registration and approval process relative to their work-related responsibilities and handling submissions. This will be a very hands-on approach to helping them to review and discuss pain points, challenges and solutions.

David will cover the following areas at this seminar:

• Which regulatory bodies in the Japanese government are responsible for medical device registration in Japan?
• In Japan, are medical devices required to be registered before they can be sold?
• What are the different regulatory classifications for medical devices?
• What are the different application categories for medical device registration?
• What does the registration pathway look like for each regulatory classification?
• What are the document requirements for notification for the various classes of medical devices?
• What are other requirements that are necessary for approval in addi...
• Is local testing (type testing/sample testing) required for registration?
• When are clinical studies required for registration?
• Is approval in the Country of Origin required for registration?

 

To join us for more information, get in touch