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.

thanks for this usefull

thanks for this usefull article, waiting for this article like this again.
rebelmouse.com

I came onto your blog while

I came onto your blog while focusing just slightly submits. Nice strategy for next, I will be bookmarking at once seize your complete rises
mercedes benz wheels

wow this good but ,I like

wow this good but ,I like your post and good pics may be any peoples not like because defrent mind all poeple ,
Nightlife in Beijing

Absolutely fantastic posting!

Absolutely fantastic posting! Lots of useful information and inspiration, both of which we all need!Relay appreciate your work.

girlfriend activation system uploaded

You know your projects stand

You know your projects stand out of the herd. There is something special about them. It seems to me all of them are really brilliant!
abc6 com

I am happy to find your

I am happy to find your distinguished way of writing the post. Now you make it easy for me to understand and implement the concept. Thank you for the post.

metallic epoxy flooring ma

Positive site, where did u

Positive site, where did u come up with the information on this posting? I'm pleased I discovered it though, ill be checking back soon to find out what additional posts you include.
Warren

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.
key lock sequence bobby rio guide review

I am very much pleased with

I am very much pleased with the contents you have mentioned. I wanted to thank you for this great article.
powerblock elite review

Positive site, where did u

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.
http://www.rebelmouse.com

Took me time to read all the

Took me time to read all the comments, but I really enjoyed the article. It proved to be Very helpful to me and I am sure to all the commenters here! It’s always nice when you can not only be informed, but also entertained!
mercedes benz wheels for sale

Penyakit Darah Tinggi

Penyakit Darah Tinggi Disembuhkan Berkat Obat Tradisional Alami amazon obat darah tinggi Yang dimaksud dengan Tekanan darah tinggi, adalah semakin meningkatnya tensi darah dalam arteri. Tahukah anda apa dimaksud pembuluh arteri? Arteri adalah pembuluh drh yang mengangkut darah dari jantung kemudian dialirkan ke semua jaringan serta organ tubuh. Tekanan darah tinggi salah satu kondisi tanpa diawali pertanda yang dirasakan para pasien. Pada kenyataannya . Tekanan darah tinggi sering didapatkan dikalangan usia lanjut. Tekanan darah tinggi dibedakan menjadi dua jenis berdasar penyebabnya, yaitu Tekanan darah tinggi esensial serta darah tinggi sekunder. hipertensi primer salah satu Tekanan darah tinggi yang hingga saat ini belum diketahui sebabnya, sedangkan hipertensi sekunder disebabkan karna adanya jenis penyakit lain. Ada beberapa hal yang menjadi pemicu dari darah tinggi misalnya tumor pada kelenjar adrenal, Kegemukan, malas berolah raga, banyak pikiran, alkohol, dll. obat hiv HIV AIDS yakni suatu virus yang mengakibatkan penyakit HIV AIDS. Virus HIV AIDS biasanya menyerang seseorang serta menyerang sistem kekebalan tubuh seseorang, sehingga mengakibatkan tubuh seseorang menjadi melemah dalam melawan infeksi. Orang yang terkena AIDS sering kekurangan sistem imun pada tubuh. obat ginjal bocor Penyakit ginjal bocor ini paling sering ditemui pada anak-anak yang menderita kelainan fungsi organ ginjal. Penyakit Ginjal bocor dapat disebut juga sebagai keluarnya protein dari dalam tubuh seseorang lewat air kemih. Merupakan sebuah anugerah luar biasa dari Allah bagi Negara Indonesia ini karna diberikan tanah yang dapat ditanami pohon manggis yang ternyata memiliki kegunaan luar biasa bagi menyehatkan kesehatan serta mengobati berbagai macam penyakit.

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.!
prevent fleas and ticks

I wanted to thank you for

I wanted to thank you for this great read!! I definitely enjoying every little bit of it I have you bookmarked to check out new stuff you post.
lines to say to a girl to turn her on

I have read your blog it is

I have read your blog it is very helpful for me. I want to say thanks to you. I have bookmark your site for future updates.
Victorino Noval Producer

Wow, cool post. I’d like to

Wow, cool post. I’d like to write like this too – taking time and real hard work to make a great article… but I put things off too much and never seem to get started. Thanks though.
rapid cycling bipolar

This is a great post. I like

This is a great post. I like this topic.This site has lots of advantage.I found many interesting things from this site. It helps me in many ways.Thanks for posting this again.
modern wonen

High Pr Blog Comment

High Pr Blog Comment Backlinks
Thanks a lot for sharing this amazing knowledge with us.

devidmiller5060

You have done a great job. I will definitely dig it and personally recommend to my friends. I am confident they will be benefited from this site.
best memory foam mattress

Very useful post. This is my

Very useful post. This is my first time i visit here. I found so many interesting stuff in your blog especially its discussion. Really its great article. Keep it up.
my year of self improvement

ministry instituted a “buddy

ministry instituted a “buddy system,” whereby well-experienced senior reviewers are teamed up with newcomers.epoxy floor coating nh

I recently came across your

I recently came across your blog and have been reading along. I thought I would leave my first comment. I don't know what to say except that I have enjoyed reading. Nice blog. I will keep visiting this blog very often.
girlfriend activation system buy

Seo Service wow, great, I was

Seo Service
wow, great, I was wondering how to cure acne naturally. and found your site by google, learned a lot, now i’m a bit clear. I’ve bookmark your site and also add rss. keep us updated...

This is my first time i visit

This is my first time i visit here. I found so many interesting stuff in your blog especially its discussion. From the tons of comments on your articles, I guess I am not the only one having all the enjoyment here! keep up the good work
slideshare net

Bei uns finden Sie sämtliches

Bei uns finden Sie sämtliches Zubehör zum Aufhängen von Bildern. Vom einfachsten Bilderhaken bis hin zur Bildaufhängung mit Diebstahlschutz. Wir als Bilderrahmenprofi haben hier alle Produkte zur Bildaufhängung in einem Shop zusammengestellt.Steckaufhänger für Leinwandbilder

wow, great, I was

wow, great, I was wondering how to cure acne naturally. and found your site by google, learned a lot, now i’m a bit clear. I’ve bookmark your site and also add rss. keep us updated.
best mattress for hip pain

Hi I found your site by

Hi I found your site by mistake when i was searching yahoo for this acne issue, I must say your site is really helpful I also love the design, its amazing!. I don’t have the time at the moment to fully read your site but I have bookmarked it and also add your RSS feeds. I will be back in a day or two. thanks for a great site.
best mattress for side sleepers

https://www.flickr.com/people/buyfacebooklike/

So luck to come across your excellent blog. Your blog brings me a great deal of fun.. Good luck with the site.
Buy Facebook Likes Cheap

dsfsf

Amazing! This blog looks just like my old one! It’s on a totally different topic but it has pretty much the same page layout and design. Wonderful choice of colors!
Simcity buildit hack

I have read a few of the

I have read a few of the articles on your website now, and I really like your style.
Google Sniper Review

Superior Singing Method Scam

It's actually a cool and helpful piece of info. I'm glad that you shared this useful info with us. Please stay us informed like this.
Superior Singing Method Scam

Auf über 300 m2 Fläche nden

Auf über 300 m2 Fläche nden wir für Ihre Kunstwerke, Bilder und Fotos den passenden Rahmen, mit oder ohne Passepartout. Unsere top ausgestatte Rahmenwerkstatt ermöglicht uns schnell und in höchster Qualität auf jeden Kundenwunsch zu reagieren. Wechselrahmen

Auf über 300 m2 Fläche nden

Auf über 300 m2 Fläche nden wir für Ihre Kunstwerke, Bilder und Fotos den passenden Rahmen, mit oder ohne Passepartout. Unsere top ausgestatte Rahmenwerkstatt ermöglicht uns schnell und in höchster Qualität auf jeden Kundenwunsch zu reagieren. Wechselrahmen

Auf über 300 m2 Fläche nden

Auf über 300 m2 Fläche nden wir für Ihre Kunstwerke, Bilder und Fotos den passenden Rahmen, mit oder ohne Passepartout. Unsere top ausgestatte Rahmenwerkstatt ermöglicht uns schnell und in höchster Qualität auf jeden Kundenwunsch zu reagieren. Wechselrahmen

Der Schwerpunkt unseres

Der Schwerpunkt unseres Angebots liegt in der Konzeption, Gestaltung und Entwicklung von Websites sowie im Online Marketing. SEO-Optimierung, Social Media Marketing (SMM) oder Responsive Webdesign sind dabei keine Fremdwörter für uns, sondern Teil unserer täglichen Arbeit.Responsive Webdesign

Der Schwerpunkt unseres

Der Schwerpunkt unseres Angebots liegt in der Konzeption, Gestaltung und Entwicklung von Websites sowie im Online Marketing. SEO-Optimierung, Social Media Marketing (SMM) oder Responsive Webdesign sind dabei keine Fremdwörter für uns, sondern Teil unserer täglichen Arbeit.Webdesign

Excellent .. Amazing .. I’ll

Excellent .. Amazing .. I’ll bookmark your blog and take the feeds also…I’m happy to find so many useful info here in the post, we need work out more techniques in this regard, thanks for sharing... dong ho deo tay gia re

Excellent .. Amazing .. I’ll

Excellent .. Amazing .. I’ll bookmark your blog and take the feeds also…I’m happy to find so many useful info here in the post, we need work out more techniques in this regard, thanks for sharing... dong ho deo tay gia re

I’m excited to uncover this

I’m excited to uncover this page. I need to to thank you for ones time for this particularly fantastic read . dong ho deo tay nu

I am very happy to discover

I am very happy to discover your post as it will become on top in my collection of favorite blogs to visit.
Amazing news

https://www.youtube.com/watch?v=juX4jmjdu4s

his is my first time i visit here. I found so many entertaining stuff in your blog, especially its discussion. From the tons of comments on your articles, I guess I am not the only one having all the leisure here! Keep up the excellent work.
Buy Facebook Likes

This is really a nice and

This is really a nice and informative, containing all information and also has a great impact on the new technology. Thanks for sharing it,
Edward Bass

I m saving your blog in my

I m saving your blog in my personal folder to visit again You made legal points within this article that I sense need further examination. I agree with most all of this info. amazing work. dong ho deo tay

I m saving your blog in my

I m saving your blog in my personal folder to visit again You made legal points within this article that I sense need further examination. I agree with most all of this info. amazing work. dong ho deo tay

http://www.bestmattressonline.com/best-mattress-options-for-plat

What a great blog, thank you for letting me comment on it.
mattress for platform bed

http://www.memoryfoammattress-guide.org/guide-to-top-memory-foam

Thanks very much for this great article;this is the stuff that keeps me going through out these day.
best foam mattress

approved devices that have

approved devices that have received upgrades and, therefore, must go through the approval process again.Loft conversions Hammersmith

Fashion encompasses many

Fashion encompasses many facets of society. What better way to experience the Full Article many fashion nuances then by have an event to express peoples dressing tastes then Fashion Week in New York Read on to learn more. psd to wordpress

Fashion encompasses many

Fashion encompasses many facets of society. What better way to experience the Full Article many fashion nuances then by have an event to express peoples dressing tastes then Fashion Week in New York Read on to learn more. psd to wordpress

http://www.bestmattress-reviews.org/consumer-reports-2013-mattre

Great, This specific net webpage is seriously thrilling and enjoyment to learn. I’m an enormous fan from the subjects mentioned.
costco air mattress