Feature Article

Japan’s Medical Device Market Is Getting Better . . .


Posted in Medical Device Business by Camilla Andersson on November 13, 2012

. . . a little better all the time. Historically hampered by a burdensome regulatory system, Japan’s medtech market is showing marked signs of improvement, thanks to efforts by the regulatory body to reduce product approval lag times and the government’s targeting of industry as a key growth sector.


It’s no secret that the Japanese medical device market was hit hard by the March 2011 earthquake and tsunami. Nevertheless, it remains a force to be reckoned with on the world stage: Japan accounts for 10% of the total global market, worth €28.24 billion at the end of 2010, according to the Ministry of Health, Labour and Welfare, and ranks as the third largest after the United States and the European Union. Moreover, the market will continue to expand, as the percentage of people over the age of 65 rises from the current 23% to 36% by 2050, as stated in a United Nations report.

An ageing population could benefit foreign companies, in particular, as Japan imports a significant number of medical products. All artificial cardiac valves (worth €141 million), 99.6% of artificial hearts (€256 million), 98.4% of artificial respirators (€376 million) and 81.4% of contact lenses (€1.6 billion) sold in Japan are manufactured abroad, according to statistics from the ministry. It’s fair to say that foreign-made therapeutic devices are conspicuous in this country (Figure 1).

 Figure 1: Countries exporting medical devices to Japan.

While Japan remains competitive in endoscopes and other diagnostic devices, the nation imports twice as many medical goods as it exports, contributing to a trade deficit of €6.1 billion, also according to ministry records (Figure 2). High-end medical technology from the United States and Europe continues to be in great demand.

Improved approval process
One of Japan’s major barriers to entry is its rigid regulatory system and infamous “lag time,” which hinders access to medical technology. Of late, the government has been more receptive to streamlining the product approval process and encouraging innovation. The Ministry of Health, Labour and Welfare has more than doubled the number of reviewers at the Pharmaceuticals and Medical Devices Agency (PMDA) in the past three years, growing from 35 in 2009 to 90 as of August 2012. The agency further aims to increase personnel to 104 by 2013. After receiving some criticism that newly hired reviewers were too young and inexperienced, the ministry instituted a “buddy system,” whereby well-experienced senior reviewers are teamed up with newcomers.

“Adding headcount alone is not our goal,” said Kazunari Asanuma, head of the ministry’s office of device evaluation. He told medical device manufacturers attending a recent regulatory seminar sponsored by the Medical Device Strategy Institute that he has even “instructed reviewers to check only the revised [parts of a device] and to ignore the rest,” in the case of previously approved devices that have received upgrades and, therefore, must go through the approval process again.

 Figure 2: Japan’s medical device trade deficit from 1992 to 2010. Exports are indicated in red and imports are in blue.

This is a bold and rare decision coming from the Japanese regulatory authority. It typically takes an overly protective stance, leaving no stone unturned when approving devices, because the ministry, and not the manufacturer, is blamed if something is found to be defective.

Other ministerial efforts to eliminate the lengthy approval process include:

  • allowing third-party entities to certify certain items;
  • clarifying the approval process and making it dependent on the device’s degree of novelty, with specialised teams assigned for each class of device;
  • expanding the consultation system during the device development and other phases.

There are two aspects to the device lag: the application period, which applies to the length of time between the development stage and completion of clinical trials and submission of application forms, and the approval period, which spans from submission of the application to the moment when approval has been obtained.

The approval process varies depending on the class or type of device. Processing and approval times for priority-review items are roughly similar to those registered by US FDA. The review process for devices that are not deemed a priority, however, generally takes 1.7 years longer in Japan than in the United States. The ministry is now working on closing that gap completely by 2015.

Proposals from industry
Junko Kodama, a director at Abbott Medical Optics Japan’s R&D division, who struggled with PMDA’s burdensome review process when submitting her company’s intraocular lenses for approval, has some suggestions for improvement. “In the United States, we were just asked to submit the names of monomers used for the lenses, but in Japan we had to present everything from the monomers’ structural formulas and degree of purity to composition percentages,” said Kodama, who is also a director at the American Medical Devices and Diagnostics Manufacturers’ Association (AMDD). Unlike drugs, where a thorough understanding of the materials is warranted, “medical equipment cannot be identified by looking at the amount of raw materials used,” said Kodama. “Reviewers should stop demanding pointless data, and instead look at device efficacy.”

PMDA’s drug-centric review process is a result of the law regulating Japan’s medical devices, which was originally designed to regulate drugs and medicines. After years of lobbying by the Japan Federation of Medical Devices Associations (JFMDA) demanding device-specific regulations, the government announced in June 2012 a renewed five-year strategy for medical innovation that included the goal of revising the Pharmaceutical Affairs Law (PAL) so that medical devices could be processed separately.

Getting there will require some patience, though, as the bill won’t be submitted to the country’s legislative body until 2013 at the earliest. It will take at least another couple of years for the revised law to come into force. Seeking faster ways to improve business prospects for industry, JFMDA, in concert with the AMDD and the European Chamber of Commerce in Japan, is currently negotiating with the health ministry to expand the range of medical device products that require no new approvals for upgrades or partial changes, and to loosen some rules for foreign medical device manufacturers, said Ryutaro Iida, who heads JFMDA’s committee for the regulatory system. “We can’t just sit and wait for the law to be revised,” he said.

Strong commitment
Japan has announced various policies to promote the development of advanced medical devices in the past five years. In April 2007, the government unveiled the first five-year strategy for the creation of innovative drugs and medical devices, which called for speeding up and improving review quality and optimising the environment for clinical trials. The plan was renewed in June 2012 with more emphasis on reinforced collaboration of government, industry and academe to create innovative drugs and devices. This medical-focused growth strategy was endorsed by cabinet members in July 2012 as part of the country’s new “revitalisation strategy,” which positioned the life sciences, environment and agriculture as primary sectors for enhanced investment. The initiative is designed to boost the value of life sciences to more than €515 billion and create more than 2.84 million jobs by 2020. The plan does not clearly state how the specific goals will be financed. This strategy is an evolved version of Japan’s growth strategy announced in 2010, in which the government for the first time defined the medtech industry as a key growth sector.

Despite a spate of policy announcements, progress has been slow. To help achieve the stated goal of making Japan a world leader in the production of innovative drugs and medical devices, the government created within the cabinet secretariat an office to focus on encouraging medical innovation. The office, which is not subordinate to a particular ministry, can oversee the whole plan and push through implementation. It acts as a “control tower,” said Takeo Asano, an office director. “We will apply the plan-do-check-act cycle to make sure that the project is running smoothly. We won’t let the plan fail in the end,” he added.

The goal is to make the indigenous medtech industry a central pillar of Japan’s international ambitions. However, the establishment of prompt and effective assessment systems also will create a favourable environment for foreign companies that want to sell their cutting-edge devices and technologies in Japan.

Miki Anzai is Associate Editor of sister publication Japan Medical Design and Manufacturing Technology.

 



Find more content on:
No votes yet


Login to post comments

Comment viewing options

Select your preferred way to display the comments and click "Save settings" to activate your changes.

I definitely really liked

I definitely really liked every part of it and i also have you saved to fav to look at new information in your site.
dual diagnosis treatment

I recently found many useful

I recently found many useful information in your website especially this blog page. Among the lots of comments on your articles. agen judi indonesia

You have raised an important

You have raised an important issue..Thanks for sharing..I would like to read more current affairs from this blog..keep posting...Cara Main Over Under

people over the age of 65

people over the age of 65 rises from the current 23% to 36% by 2050, as stated in a United Nations report.voyance gratuite telephone

Thanks for sharing nice

Thanks for sharing nice information with us. i like your post and all you share with us is uptodate and quite informative, i would like to bookmark the page so i can come here again to read you, as you have done a wonderful job.
knockerball good morning america

It is the old what goes

It is the old what goes around comes around routine.voyance web

Thanks for the blog loaded

Thanks for the blog loaded with so many information. Stopping by your blog helped me to get what I was looking for.
Yacht Charter Dubai

I am hoping the same best

I am hoping the same best effort from you in the future as well. In fact your creative writing skills has inspired me.
penguin method free pdf

I am very happy to read this.

I am very happy to read this. This is the kind of manual that needs to be given and not the random misinformation t hat's at the other blogs. Travel Blog Travel News Travel Guide

Thanks for sharing the post..

Thanks for sharing the post.. parents are worlds best person in each lives of individual..they need or must succeed to sustain needs of the family.
Greek restaurants London

I’m happy I located this

I’m happy I located this blog! From time to time, students want to cognitive the keys of productive literary essays composing. Your first-class knowledge about this good post can become a proper basis for such people. nice one Immigration DNA Test

This is very educational

This is very educational content and written well for a change. It's nice to see that some people still understand how to write a quality post!
Make Women Want You Jason Capital

Good artcile, but it would be

Good artcile, but it would be better if in future you can share more about this subject. Keep posting.
https://www.rebelmouse.com/obsessionphrasesreviews/

I would like to thank you for

I would like to thank you for the efforts you have made in writing this article. I am hoping the same best work from you in the future as well. Thanks...
Magic of making up

You have raised an important

You have raised an important issue..Thanks for sharing..I would like to read more current affairs from this blog..keep posting...rebelmouse article

Actually I read it yesterday

Actually I read it yesterday but I had some thoughts about it and today I wanted to read it again because it is very well written. gossip lanka news

I definitely enjoying every

I definitely enjoying every little bit of it. It is a great website and nice share. I want to thank you. Good job! You guys do a great blog, and have some great contents. Keep up the good work...
Internet Marketing Services
https://www.seowebanalyst.com/marketing-services.html

I was reading your article

I was reading your article and wondered if you had considered creating an ebook on this subject. Your writing would sell it fast. You have a lot of writing talent.
Tener un Hijo

Really functional for me, as

Really functional for me, as it accommodates many of info car rental jaipur to delhi

had considered creating an

had considered creating an ebook on this subject. Your writing would sell it fast. You have a lot of writing talent.. delhi to jaipur taxi

Wonderful illustrated

Wonderful illustrated information. I thank you about that. No doubt it will be very useful for my future projects. Would like to see some other posts on the same subject!
list academy review

Hello There. I found your

Hello There. I found your blog using msn. This is an extremely well written article. I will be sure to bookmark it and return to read more of your useful information. Thanks for the post. I’ll certainly comeback.
How to Sing

Its a great pleasure reading

Its a great pleasure reading your post.Its full of information I am looking for and I love to post a comment that "The content of your post is awesome" Great work.
spy mobile

This is a great inspiring

This is a great inspiring article.I am pretty much pleased with your good work.You put really very helpful information. Keep it up. Keep blogging. Looking to reading your next post.
videogame

Hi, I find reading this

Hi, I find reading this article a joy. It is extremely helpful and interesting and very much looking forward to reading more of your work..
children learning reading program reviews

It is extremely helpful and

It is extremely helpful and interesting and very much looking forward to reading more of your work.. packers and movers pune rates

Hi, I find reading this

Hi, I find reading this article a joy. It is extremely helpful and interesting and very much looking forward to reading more of your work..
2 1 ses sistemi fiyatlari

I really appreciate this

I really appreciate this wonderful post that you have provided for us. I assure this would be beneficial for most of the people.
www.crossfitaalst.be

This is highly informatics,

This is highly informatics, crisp and clear. I think that everything has been described in systematic manner so that reader could get maximum information and learn many things.
Fujitsu 18 LFC

Thanks a lot for sharing us

Thanks a lot for sharing us about this update. Hope you will not get tired on making posts as informative as this.
MeMyFriends com

This is a great inspiring

This is a great inspiring article.I am pretty much pleased with your good work.You put really very helpful information...
series online

Thanks for a wonderful share.

Thanks for a wonderful share. Your article has proved your hard work and experience you have got in this field. Brilliant .i love it reading.
great solution to your cash flow program

their needs shift to

their needs shift to “draw-down” products, such as annuities and structured income contracts. [...]
text your ex back forum

A thoughtful insight and

A thoughtful insight and ideas I will use on my blog. You have obviously spent a lot of time on this. Well done!
rebelmouse com

E-Factor Diet Review: Facts

E-Factor Diet Review: Facts And Figures Every Consumer Should Know About John Rowley's Guide to Increase Your Fat Burning Hormones.https://www.rebelmouse.com/efactordiet_reviews

You have a real ability for

You have a real ability for writing unique content. I like how you think and the way you represent your views in this article. I agree with your way of thinking.
alternative music

asda

I know your expertise on this. I must say we should have an online discussion on this. Writing only comments will close the discussion straight away! And will restrict the benefits from this information.
check it out

Even so, introductory pricing

Even so, introductory pricing by the major vendors is fairly attractive, thus making single-mode chips better suited for handheld point-of-care or home-use medical devices. While there is every indication that BLE will achieve global uptake similar to Bluetooth, it remains unproven in the market and the risk around new technology should not be ignored
freestanding baths

Excellent post, went ahead

Excellent post, went ahead and bookmarked your site. I can’t wait to read more from you. Will Dr David Pearson diabetes free program work for me

Awesome and interesting

Awesome and interesting article. Great things you've always shared with us. Thanks. Just continue composing this kind of post.
loft conversions cambridge

Thanks a lot for sharing this

Thanks a lot for sharing this amazing knowledge with us. This site is fantastic. I always find great knowledge from it. backlinks seo service

Because the admin of this web

Because the admin of this web site is working, no question very soon it will be famous, due to its quality contents. bust mannequin

I like the part where you say

I like the part where you say you are doing this to give back but I would assume by all the comments packers and movers in pune

I found your this post while

I found your this post while searching for some related information on blog search...Its a good post..keep posting and update the information.
loftplan liquidation

but depending on your product

but depending on your product and organisation's abilities, there is a path that is right for you. This article provides examples of different choices made by our colleagues and clients and their outcomes to guide your decision-making
procell

I always prefer to read the

I always prefer to read the quality content and this thing I found in you post. more about the author

mypsychicadvice numerology

mypsychicadvice numerology horoscope Get your Free Numerology Horoscope Numerology by mypsychicadvice.com
http://www.mypsychicadvice.com/category/mypsychicadvice-numerology-horoscope.aspx

I am happy to find this post

I am happy to find this post very useful for me, as it contains lot of information. I always prefer to read the quality content and this thing I found in you post. home inspection training

wallens

Positive site, where did u come up with the information on this posting?I have read a few of the articles on your website now, and I really like your style. Thanks a million and please keep up the effective work.
loft conversions london

I feel very grateful that I

I feel very grateful that I read this. It is very
helpful and very informative and I really learned a lot from it
Read more
niche backlinks