POLICY & REGULATION

Japan on the move to develop aworld-class medtech industry

This time the government is looking to collective decisionmaking to drive progress, with the novel idea that the three
ministries would make up the membership of MIPO and the
body that oversees it, the MIC (Medical Innovation Council).
Both MIPO and MIC are packed with ministry representatives
including the three vice-ministers, plus advisors fromacademia, the healthcare services and industry. In theory,at least, policy matters relating to the medical technology
industry are now handled as part of a single strategy.
Decisions and problems can be taken back to the ministries
by their own insiders, who can then push for action and thegreater good.

ClinicThe Japanese Government has identified the life sciencesrelated industries as one of its “pillars” of future economic
growth. Its goals include expanding the healthcare industries
and services, including nursing, to increase these markets by¥4.5 trillion ($ 57bn) and to create 2.8 million jobs by 2020.
The initiative is partly aimed at mitigating the effects ofJapan’s ageing population. Japan’s working population reached
its highest point in 1995 at 87 million. It has since been in
decline and it is expected to have fallen by 20 million in 20years’ time. New technologies and services hold out thepromise of healthier, more active ageing. Equally, the needs ofthe elderly are spurring the creation in Japan of new exporting
industries capable of supplying Asia’s growing markets andtheir expanding elderly populations.
The development of a world class medical technology
industry is one of the keys to this strategy and for some,
it would be the realisation of a long-held ambition. The
Japanese market for medtech products currently stands ataround ¥2.2 trillion ($28bn), of which imports comprise 61%.
This includes kidney machines (20% of which are imported);
general hospital products (34% imported) ; wound care (64%imported); general and vascular catheters (77% and 55%imported, respectively); orthopaedic and general implants(78% and 91% imported, respectively); and cardiac rhythm
management products where imports account for 100%of the market. This dependence on imports is longstanding
and many in the industry and in government hope that withincreased exports, medical technology might one day make apositive contribution to the balance of payments.
Central to the initiative is Japan’s Medical Innovation
Promotion Office (MIPO), established in early 2011. It is tasked
with coordinating the expansion of medical technology andother sectors. One of the first problems the government
addressed was how to coordinate medical technology-related
policies that are divided between three ministries: the Ministryof Education, Culture, Sports, Science and Technology is
responsible for basic science; the Ministry of Economy, Tradeand Industry bridges scientific discovery and the developmentof medical products; and the Ministry of Health, Welfare andLabor oversees the clinical and marketing regulations for thefinal medical products. In the past, the plans of the three
ministries were executed more in isolation than as part of an
integrated strategy. The results were not encouraging.

aDerrick Buddles

Its ageing population and the need for new sources of economic growth isgalvanising the Japanese government to build up its domestic medtech industry. Its
action plan include coordinating policy from within ministerial silos, encouraging
non-medtech manufacturers to diversify into the medical devices sector and using
the needs of the elderly as a catalyst to create new exporting industries, writes
Derrick Buddles, director of the Tokyo-based American Medical Devices andDiagnostics Manufacturers’ Association (AMDD)

12© Informa UK Ltd 2012

The needs of the elderly are spurring thecreation in Japan of new exporting industries
capable of supplying Asia’s growing markets
and their expanding elderly populations

Part of the inspiration for this initiative is Japan’s belief
in the prowess of its manufacturers. To tap into this, MIPO
is encouraging manufacturers from other fields to enter themedtech sector. This includes using a model reminiscentof Japan’s auto and electronics industries, whereby large
companies partner with SMEs (small and medium sizedenterprises) to mix the wide marketing and manufacturing
reach of the former with the advanced technologies developedby the latter.
Japanese science and medicine is also seen as a sourceof competitive advantage. Here, MIPO is working to improveindustry’s uptake of academic research results and to deepen
collaboration between hospitals and industry to increase theflow of new ideas into new products and services. Similarly,
it wants to improve academia’s willingness to move beyond
the purely scientific all the way to applications. Ten years ago,very few new ventures came out of Japan’s university. Threeyears ago, Japanese academics were founding around 150
new science-based companies a year, but few were surviving.
Today, MIPO is trying to channel venture capital to the more
promising start-ups to improve their chances of success.
Although most of the efforts in this initiative are domestic,
the global nature of the medical technology industry and of

www.clinica.co.ukAugust 2012

POLICY & REGULATION

science has not been lost on the planners. MIPO wants Japan
to become a more attractive place for overseas technology
companies and researchers, and the Government is taking an
increasingly active role in courting overseas investors.
Is the government providing the spark needed for thesector to take off in Japan? Perhaps, but a number of issues
will need to be addressed before new exporting industries
spring into life. Japanese product approval will need to madeless of a hurdle through greater global harmonization, andregulatory structures and working practices will have to
become more effective. The funding of medical technology
purchases will also need to be considered. Current demand

for medical technology products is expanding faster thanthe budgets to pay for them, the difference being partly
met through regular reimbursement cuts. But this can only
be a temporary fix. And domestic companies that could betempted by the medical technology sector will be looking fora home market with a commercially attractive outlook andprices that are relatively stable.
Medical technology is a crowded and highly competitive
business, but MIPO has big ambitions. If Japan succeeds inthe medical technology sector as it has in other industries, itwill to the benefit of patients and the aged around the world
and to the long-term good of the industry itself.

Southeast asia aims for medtech
regulatory standardisation by 2015

August 2012

• the product’s commercial marketing
history;• the intended uses and indications inlabelling;• the list of regulatory approvals ormarketing clearances obtained;• the status of any pending request
for market clearance; and• important safety/performance
related information.
The AMDD follows a risk-based
system for classifying devices into
four groups. In cases where a device
can be assigned to two or morecategories, the regulatory authority of
the concerned member state would beresponsible for assigning the productto the category that represents thehighest health risk posed to an enduser of the medical device.
If a device is designed to beused in combination with anotherdevice, the two products would
have to be classified separately.
In case of a dispute on account of
the classification rules, the AMDD
authorises the regulatory authority ofthe member state to “decide on theproper classification or reclassificationof the device concerned, whereappropriate”. However, each member
state that reclassifies or differs in its
application of the classification rules
would have to inform the ASEAN
Medical Device Committee of suchmeasures along with the reasons
behind its decision.

icaone of the 12 working groups of theASEAN Consultative Committee forStandards and Quality (ACCSQ).
Once the AMDD is finalised, its
implementation would be co-ordinated,reviewed and monitored by the ASEAN
Medical Device Committee (AMDC).
A technical committee comprisingrepresentatives from regulatory
authorities, industry and academia
may also be established to provide
assistance in reviewing technical andsafety issues.

Clin

The much-anticipated ASEAN Medical
Device Directive (AMDD) that aims tostandardise the regulation of medtech
products in the southeast Asian
region by 2015 has been issued forstakeholder consultation.
The final directive will have tobe ratified by all ASEAN member
countries ie Brunei Darussalam,
Cambodia, Indonesia, Laos, Malaysia,
Myanmar, Philippines, Singapore,
Thailand and Vietnam. Efforts
are under way to ensure that theratification takes place no later thanthe end of 2014.
The ratification will involve each
ASEAN member state confirming thatit has made the necessary changes
to its domestic laws to comply withthe provisions of the AMDD. When
finalised and ratified, only medical
devices conforming to the provisionsof the AMDD and its annexes would
be allowed onto the markets in theseregions.
Stakeholders have until 31 August
to submit feedback on the draft
AMDD. Singapore’s Health Sciences
Authority, which posted the draft
AMDD on its website, said any
comments submitted after the August
deadline would not be considered“due to time constraints”. This isbecause ASEAN member states are
keen on establishing the “ASEAN
Economic Community” by 2015.
Efforts to harmonise the medtech
regulations in ASEAN countries havebeen headed by the Medical Device
Product Working Group (MDPWG),

Common submission format

Among other things, the draft AMDD
calls for adopting the Common
Submission Dossier Template (CSDT)
as the common format for making
submissions to all ASEAN regulatory
authorities.
The adoption of a CSDT would
help eliminate the differences
documentation formats that
presently exist in different ASEAN
jurisdictions. The use of CSDT meansthat companies would not have toprepare multiple dossiers with thesame information arranged in different
formats for submitting them todifferent regulatory authorities.
The AMDD states that the CDST
should be accompanied by an
executive summary containing:• an overview of the application (egintroductory descriptive informationon the medical device, the intended
uses and indications for use, any
novel features and a synopsis of thecontent of the CSDT);www.clinica.co.uk

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