Japan PMDA Approval as a Business Value Investment

by Philip O'Neill

Japan is an excellent market:

As we have been saying for years, Japan is an excellent market for Medical Devices and Healthcare technologies. Japan is the third largest market with a ultra aging population. Along with this, Japanese healthcare providers, doctors, nurses, hospitals, and care facilities, are always looking for the latest gear from around the world. A unique, universal healthcare system makes the highest grade medical devices, pharmaceuticals, and treatments available to everyone. 

Japan is also offers regulatory stability and predictability Recent developments in the USA make the political stability and regulatory capacity of Japan even more valuable. 

PMDA Approval on its own is worth the effort.

Even if you don't plan to market your device in Japan immediately, PMDA approval can help raise the value of your business by 5% to 10%.

The PMDA is one of the world's premier regulators, with a reputation for science-based processes and approvals. 

PMDA approval sends a message that your device is of the highest quality, and that your company is ready for world markets. 

PMDA is also the reference regulator for most of Asia, which means your approvals can be quicker and less difficult for rapidly growing markets around the world. 

These major markets, representing huge market opportunities, offer accelerated or simplified approvals for devices and IVDs that are approved in Japan: 

  • Taiwan
  • Singapore
  • Malaysia
  • Mexico
  • India
  • Australia and
  • Thailand all represent opportunities that are eased with a Japan registration or approval*.

The Japan market itself is the 2nd or 3rd largest in the world for most devices, and the PMDA approval or registration makes your entry into a vast Asian and world market more rapid. 

Contact us at info@parkdale-group.co.jp to arrange a call to see how we can work together to build your international business. 

Philip O'Neill, CEO-Representative Director 

Parkdale Group Inc. is a Canadian-owned and operated company, based in Kyoto, Japan. 

*source: MDA’s Activities Leading to
Medical Device Innovation    000264825.pdf

This information collected from the PMDA. This blog post is Copyright, Parkdale Group Inc. 2025. 

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