POSITION OF JAPANESE MEDICAL DEVICE MARKET IN GLOBAL MARKET

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JAPANESE MARKET OF MEDICAL
DEVICES
PRESENTED BY-
Anup kumar
Dept. of Medical Devices
(NIPERA1618MD01)
SUBMITTED TO-
Dr. Mukty Sinha

2. CURRENT MARKET TRENDS
According to MHLW, the japanese market for medical
devices reaching in 2016 was approximately $37.6 billion
& expected to reach $45 billion by 2020.
Becomes large (ranked 2nd in growth rate) and well
established.
Remains heavily dependent on importers,especially for
sophisticated devices
The official figures for U.S exports to japan were limited to
23% market share.
Espicom Business Intelligence reported that Japans’s
medical device market will exhibit a CAGR of 3.8% from
2013 to 2018.
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USA
43%
EU
26%
JAPAN
14%
OTHERS
17%
GLOBAL STATISTICS ON MEDICAL DEVICES
PRODUCTION(2016)

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STATISTICAL CHANGES

5. WHY JAPAN…?
High expectations due Japan’s
aging population of 127
million& continued demands on
improved treatment as well as
better quality of life for
advanced sophisticated medical
devices &regenerative
medicines.
3rd largest global economic
country.10/27/2016 5

6. PMDA…
It is a Japanse regulatory agency that working together
with MHLW to protect the public health by assuring
safety, efficacy and quality of pharmaceuticals and
medical devices.
FUNCTIONS-
GLP/GCP/GMP/QMS inspection
Scientific review of marketing authorization
application of medical devices
Monitoring of post-marketing safety
Monitoring of clinical trials & it’s data analysis.
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7. MHLW…
The Ministry of Health, Labor and Welfare(MHLW) is
one of the regulatory authority of the pharmaceutical
as well as Medical devices in Japan.
PFSB handles the following function of MHLW….
Issue of a manufacturing license
Monitoring of clinical studies & it’s data
Give a marketing approval & reviews that approval
if required
Issue a license for marketing authorization holder.
Post-marketing safety measures
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8. CLASS I DEVICES…
General controlled medical
devices with extremely low risk.
Regulatory requirements-
I. Self-declaration without no
certifiticate by
PMDA(Todokede)
II. Pre-market submission of
marketing notification to
PMDA
Examples- x ray film,scalples,
knife, sphygmomanometer
etc.
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9. CLASS II DEVICES…
Specified controlled and controlled
medical devices with moderately
low risk to human body.
REGULATORY REQUIREMENTS-
I. Pre-market certification
(Ninsho)to be granted by a
registered third-party certification
body like Fuji pharma co. ltd,
cosmos corporation, Japan
chemical quality assurance org.
etc.
Examples- MRI, Digestive
catheters etc.
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10. CLASS III DEVICES…
 Highly controlled medical
devices with medium risk to
human body.
 REGULATORY
REQUIREMENTS-
I. Pre-market approval (shonin)
from MHLW Minister to be
granted based on the scientific
review at PMDA.
 Examples- Artificial bones,
dialyzer etc.
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11. CLASS IV DEVICES…
Specially highly controlled
medical devices with high risk to
human body.
REGULATORY
REQUIREMENTS-
I. Pre-market approval (shonin)
from MHLW Minister.
Equivalent to class III of EU
MDD.
Examples-Cardiac stents,
artificial heart
valves,pacemakers etc.
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12. BUSINESS MODELS…
It varies depending on the-
I. Uniqueness and Technological
levels of device
II. Financial means and possibility to
invest in the Japanese market
Types of model-
A. Establishing own company in
Japan
B. Joint development with local
partner
C. Licensing out
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13. REGULATORY PROCESS…
It involves a seven steps approach to Japanese market
access.
STEP I- Determination of regulatory pathway by
finding out device classification according to the PAL
& the availability of a JMDN code.
STEP II- Appointing a local organization like MAH or
D-MAH for registration of the product ,manufacturing
facilities and creating bonding with PMDA.
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14. MAH & D-MAH REQUIREMENTS
Should be based in Japan
Having the formally licenced by MHLW
Must be employ at least three staff members-
General manager
Quality manager
Safety manager
Must implement GQP and GVP system
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15. REGULATORY PROCESS(CONT’D)
STEP III- Submit application to the PMDA for a
“Foreign Manufacturer Accreditation”
Needed when manufacturing facilities are located
outside Japan.
Attached the new registration form(Form No. 18) to
obtain a product manufacturing code.
Supporting documents such as medical certificates,
product lists, summarization of features etc.
should be included.
MAH submit the form to PMDA.
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16. REGULATORY PROCESS(CONT’D)
STEP IV- Implementation of a quality system
compliant with the PAL & MHLW
Preparation and submission of QMS conformity
assessment application.
QMS is similar to ISO 13485 and US Quality system
regulation(21 CFR part 820)
Although QMS is largely based on ISO 13485:2003; in
few cases MHLW ordinance 169 also being
implemented.
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17. REGULATORY PROCESS(CONT’D)
STEP V- Preparation and submission of medical
device certification/approval to PMDA or RCB
depend on how device is classified in the Japanese
system.
CLASS I- Todokede & premarket submission of
marketing notification to PMDA.
CLASS II- Ninsho to RCB or 3rd parties
CLASS III & CLASS IV – Shonin to MHLW Minister.
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18. REGULATORY PROCESS(CONT’D)
STEP VI- Quality management system audit
PMDA- It conducts on site audits for new medical
devices, class II controlled, class III & CLASS IV
devices and those devices requiring clinical
investigations.
RCB- It conducts the audit for class II specified
controlled devices.
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19. REGULATORY PROCESS(CONT’D)
STEP VII – Final certification process by PMDA or
RCB
Submission of an insurance coverage request
Class I – No certification from PMDA/RCB
Class II – Pre-market certification issued by RCB with
in 3-6 months.
Class III & Class IV – Pre-market approval certificate
issued by MHLW with in 8-16 months. This
certificate does not expire.
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20. COMPARISON…
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JAPANESE USA EU
1.Total market value-$37
billion
2.It imports around 35%
3.Regulatory agencies are
PMDA,MHLW & RCB.
4.Classification done
mainly based on risk.
5.Submitted documents for
certification are
Todokede,Ninsho&shonin.
1. Total market value-
$150 billion
2. It imports 2-5%.
3. US-FDA,CDRH
control the regulatory
process.
4. Devices are classified
based on risk.
5. It including Pre-
market notification
i.e 510(k) &PMA.
1. Total market value-$58
billion
2. It imports 10-15%
3. Notified Bodies &
Harmonization
Standardization act as
regulatory agencies.
4. Classification based on
degree of invasiveness,
body contact
time,local&systemic
effect .
5. According to CE
modules different
technical documents
submitted for CE
marking

21. COMPARISON(CONT’D)…
JAPANESE USA EU
6.Standards are QMS for
medical devices #1128 &
GMP #40/63 ordinance.
7.Conformity assesment
done by Government
body.
8.Product recall and
approval result publically
not disclosed.
9.Data of clinical trials
needed in details for
certification.
6. It follows QS(21 CFR
Part 820)
7.It is also done by
Government.
8. All the information
related to regulatory
publically disclosed in
respective US-FDA
website.
9. It also involved clinical
trials in details.
6.It follows EN46001 /ISO
13485 & EN46002/ISO
13488
7.A third party involved.
8. Such type of
information not
publically disclosed
9. Clinical trials are done
but not in details.
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22. CONCLUSION…
With manufacturing of innovative & unique medical
devices and having a total market volume of 37 billion Euro
,Japan now becomes world’s second largest medical devices
behind the US.
Still,it imports about 35% of devices and have access to
only half of the advanced medical devices that are
available in the US & EU due to the complicated
regulatory process.
However, in an effort to ease market access, Japanese
MHLW has been implementing an action programme
focusing on highly needed medical devices for faster
approval review.
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