As you start to map out your global strategy beyond the US, Canada and Europe, there are six key steps to follow and multiple regulations to consider. Harmonization has increased in recent years, yet most countries still maintain distinct medical device regulatory systems. Careful analysis on a market-by-market basis will help you to fully realize compliance requirements affecting a particular market. Explore these six steps as we reveal insights into the unique medical device regulations affecting markets in Russia, Brazil, Japan, China, and India.

1. SIX STEPS
to A
t Access Global
Gl b l
Medical Device Markets
October, 2013
Justin Heyl, Consulting Program Manager at Intertek
Heyl
Bhavesh Sheth, Consultant
1
www.intertek.com

2. Meet Our Presenter: Justin Heyl
Justin Heyl is Intertek’s Consulting
Program Manager. Leading Intertek’s
medical device consulting team, Justin
partners with startups as well as Top
10 companies th
i throughout th i
h t their
development cycles to expedite
market access on a global scale.
2
www.intertek.com

3. Meet Our Presenter: Bhavesh Sheth
Bhavesh Sheth is Intertek’s lead
consultant for FDA 510(k)
submissions. With extensive
knowledge of requirements and the
applicability of various national and
international standards for design,
safety, performance, risk analysis,
f t
f
i k
l i
biocompatibility, sterilization, and
labeling of medical devices,
Bhavesh s
Bhavesh’s regulatory expertise will
help you avoid project delays and
meet your business goals.
3
www.intertek.com

4. An Extensive Global Network
• Leading quality solutions provider
• Origins back to 1885
g
• Market Capitalisation > £5bn
• 2012 Sales £2.0bn, EBITA £335m
(
(16.3%)
)
• 9.0% Average FY Organic
Revenue growth 2002-12
More than
1,000
More than
100
laboratories
and offices
countries
36,000
,
people
4
www.intertek.com

5. Where do you want to go?
Russia
China Japan
India
Brazil
5
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6. Here’s how to get where you want to go.
Six Steps to Global Markets
1.Regulatory Background
2.Product Assessment
3.Device Classification
4.In-Country Representation
g
q
5.Registration Requirements
6.Preparation & Submission
6
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7. Country Profile: China
• By 2015, Medtech Market Projected to be $11.4 billion
vs. U.S. $160B vs. Europe $115B
•
•
•
•
Medical Device Market $ billion
$9
Annual per capita healthcare spend $432 (5.2% GDP)
Per Capita spend on Medical Devices $12.6
Medtech Market Forecasted Growth 20% through
2018
• $120 Billion Healthcare stimulus initiated in 2009 has
spurred investment in infrastructure, creating
tremendous opportunity for manufacturers
• 70% of high end medical devices are
imported
7
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8. Country: China
Step 1
p
8
Regulatory Background
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9. Step 1: Regulatory Background
The China Food and Drug Administration (CFDA) was founded
g
(
)
on the basis of the former State Food and Drug Administration
(SFDA).
In March 2013, the regulatory body was rebranded and
restructured as the China Food and Drug Administration.
It i responsible for supervision and administration of medical
is
ibl f
i i
d d i i t ti
f
di l
devices in China.
9
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10. Country: China
Step 2
p
10
Product Assessment
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11. Step 2: Product Assessment
"Medical devices" - instruments, equipment, tools, materials
, q p
,
,
and other objects, including the software, that are designed to
be used on the human body.
1.Prevention, diagnosis, treatment, monitoring or remission of
diseases
2. Diagnosis, t t
2 Di
i treatment, monitoring, remission or compensation
t
it i
i i
ti
of injury or physical disability
3.Research,
3 Research replacement or adjustment of anatomical or
physiological process
4.
4 Control of pregnancy
Source: http://eng.sfda.gov.cn/WS03/CL0767/61641.html
11
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12. Country: China
Step 3
p
12
Device Classification
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13. Step 3: Device Classification
Class I - Devices for which safety and effectiveness can be ensured
y
through routine administration (products such as rehabilitation
techniques, disinfecting devices and apparatus)
Class II - Devices for which further control is required to ensure their
safety and effectiveness
Class III – Hi h i k d i
Cl
High-risk devices such as th
h
those
implanted into the human body, or used for life
support or sustenance; or the ones that pose
potential risk to the human body (products such
as implanted artificial internal organs and infant
care devices)
The classification system
is i il t
i similar to EU and U.S.
dUS
in that there are 3 device
classes. However, a
Class II device in the US
or Class IIa/IIb device in
the EU may be classified
as Class III in China.
Source: http://eng.sfda.gov.cn/WS03/CL0767/61641.html
13
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14. Country: China
Step 4
p
14
In-Country
In Country
Representation
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15. Step 4: In-country Representation
Appoint a "Legal Agent and After Sales Agent" to co-ordinate
pp
g
g
g
CFDA device registration.
• Agents must be legal residents of China or maintain local business
presences in China.
• Legal Agent interacts with the CFDA during the device registration
process and assists in obtaining registration renewal every four years
• After Sales Agent is responsible for reporting all incidents related to
the device to Chinese authorities following registration and
commercialization of th d i i Chi
i li ti
f the device in China.
15
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16. Country: China
Step 5
p
16
Registration
Requirements
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17. Step 5: Registration Requirements
P
Prepare and submit an application t CFDA f an I
d b it
li ti to
for
Import M di l D i
t Medical Device
Registration Certificate (IMDRC).
Proof of registration in country of origin is required
required.
17
This i diff
Thi is different
t
compared to U.S and
EU, where device
approvals and
registration are strictly
g
y
based on the
evaluation carried out
by FDA or Notified
Bodies.
www.intertek.com

18. Step 5: Registration Requirements
Submit the device to CFDA for testing. Testing is carried out by the CFDA
g
g
y
Medical Device Quality Supervision and Inspection Center.
Clinical trials conducted in China could be required for devices that do
not have regulatory approval in another country, and for high-risk devices.
Except for new implant products and in-vitro reagents, foreign clinical
data
d t are mostly accepted and l
tl
t d d local i
l investigation could b exempted i
ti ti
ld be
t d in
most circumstances.
18
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19. Step 5: Registration Requirements
China Compulsory Certification (
p
y
(CCC) is applicable to some medical
)
pp
devices with electrical components for safety conformity.
If the device requires CCC Mark Certification, it must be obtained through
testing the device in labs in China. An on-site audit of the legal
manufacturer is also required.
19
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20. Country: China
Step 6
p
20
Preparation &
Submission
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21. Step 6: Preparation & Submission
Prepare Chinese Registration Standard dossier, including testing results,
p
g
,
g
g
,
and submit to CFDA for approval.
Foreign manufacturers must submit quality system certificates – ISO
13485 or show compliance with U.S. FDA Quality System Regulations.
These are adequate to meet CFDA quality management system
requirements
21
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22. Step 6: Preparation & Submission
CFDA reviews the application and issues IMDRC certificate, which is
pp
,
valid for 4 years.
Re-Registration is necessary in cases such as:
•
•
•
•
•
Manufacturer change
Manufacturing site change
Product name, model or components change
Indications for use change
Chinese registration standard (YZB) change
Timeline:
Entire process can generally take up to 12 months (class I device), 18
months (class II device) and about 36 months (class III device).
22
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23. Country Profile: Brazil
• Medical device market valued at nearly $5.9 billion.
• Population g
p
growing at .9% annually
g
y
•
•
•
•
•
6.7% of population 65 or older
Per capita health care expenditure $1,121
Total
T t l expenditure on health as a % of GDP 8 9%
dit
h lth
f GDP: 8.9%
Total population: 199,000,000
Medical device imports $2.8bn in 2012.
23
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24. Country: Brazil
Step 1
p
24
Regulatory Background
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25. Step 1: Regulatory Background
Medical devices in Brazil are regulated by the National Health
g
y
Surveillance Agency (Agência Nacional de Vigilância Sanitária,
ANVISA)
25
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26. Country: Brazil
Step 2
p
26
Product Assessment
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27. Step 2: Product Assessment
Per Annex I of Brazilian Resolution RDC 185/2001; a medical
;
device is defined as follows:
Product for use in health, such as equipment, apparatus, material,
article or system of use in health or implementing medical, dental
or laboratory, for prevention, diagnosis, treatment, rehabilitation or
contraception, and not using pharmacological, immune or
metabolic means to perform their main function to humans, may
however be assisted in his duties by such means.
27
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28. Country: Brazil
Step 3
p
28
Device Classification
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29. Step 3: Device Classification
Device Classification System:
y
•
•
•
•
Class I
Class II
Class III
Class IV
Class I and II i l d l
Cl
d include low and medium risk
d
di
i k
devices. Class III and IV include higherrisk devices
29
4 d i classes means the
device l
th
classification system is
slightly different from
U.S. FDA
However, Brazilian
Resolution RDC 185/01 is
designed similarly to the
European Medical Device
Directive (93/42/EEC)
(93/42/EEC).
Classes I, II, III and IV in
Brazil are similar to Classes
I, IIa, IIb and III in the
European Union
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30. Country: Brazil
Step 4
p
30
In-Country
In Country
Representation
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31. Step 4: In-Country Representation
Appoint a company that holds a Company
pp
p y
p y
Working Allowance permit from ANVISA as
the Brazil Registration Holder (BRH).
Similar to EU - Companies
without a location in Europe
must appoint an Authorized
Representative to act on their
behalf
In case of U.S., foreign
manufacturers must appoint
“US Agent” and the company
and device should be
registered. No certificate is
issued by FDA but the
company is subject to random
FDA inspections for QSR
compliance.
31
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32. Country: Brazil
Step 5
p
32
Registration
Requirements
www.intertek.com

33. Step 5: Registration Requirements
It is mandatory to register all medical devices listed in RDC No.
y
g
185, except those products referred on items 2, 3 and 12 of Part
3 of this regulation.
Prepare Technical File that includes information on the device.
Obtain Certificate of Free Sale (CFS) or device
registration certificate proving home-country
approval
- OR –
The Registration
requirements are
similar to EU and U.S.
in that all devices have
to be registered.
Demonstrate evidence of registration in two other
markets and justify why the device does not have
home-country approval.
home country approval
33
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34. Step 5: Registration Requirements
Certain devices require INMETRO Certification, including medical
q
,
g
devices sold in Brazil that fall under the scope of the following
standards:
• NBR IEC 60601 series
• NBR ISO 6875:1998: Dental patient chair
• NBR ISO 7785-2:2004: Dental handpieces – Part 2:
Straight and g
g
geared angle handpieces
g
p
• NBR ISO 9919:1997: Medical electrical equipment –
Particular requirements for the basic safety and essential
performance of pulse oximeter equipment for medical use
• NBR ISO 11195 2000 G mixers f medical use –
11195:2000: Gas i
for
di l
Stand-alone gas mixers
This process is quite
similar to EU and U.S.
FDA's test data
evaluation and policy
of accepting test
reports
• NBR ISO 8835-2:2010: Inhalational anaesthesia systems
– Part 2: Anaesthetic breathing systems
34
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35. Country: Brazil
Step 6
p
35
Preparation &
Submission
www.intertek.com

36. Step 6: Preparation & Submission
Submit the registration application and Technical File to ANVISA
g
pp
through BRH. ANVISA reviews registration application.
High-risk and innovative devices must meet
g
ANVISA clinical trial requirements. ANVISA
usually accepts clinical trial results previously
conducted in other markets as adequate to
meet such requirements.
36
Technical files required by
ANVISA resemble
documents required by the
U.S. FDA.
Applicants that have
already prepared Technical
Files for CE
Marking or U.S. FDA 510(k)
submissions may usually
reuse similar information to
prepare their Brazilian
Technical Files.
www.intertek.com

37. Step 6: Preparation & Submission
Once approved, ANVISA will p
pp
,
publish registration number in the Diário
g
Oficial da União (DOU).
Note: Both ANVISA device registrations and INMETRO certifications
must be renewed every five years
37
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38. Country Profile: Russia
• 73% share of healthcare market supplied by
imports
• 143 million population
• $6B is the value of the Russian market for
medical equipment and supplies
• $42 per capita healthcare expenditure
Source: U.S. Commercial Service, ReporterLinker
38
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39. Country: Russia
Step 1
p
39
Regulatory Background
www.intertek.com

40. Step 1: Regulatory Background
Roszdravnadzor (Federal Service for Control of Healthcare and
(
Social Development in the Russian Federation) oversees all
domestic and imported medical devices in Russia.
40
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41. Country: Russia
Step 2
p
41
Product Assessment
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42. Step 2: Product Assessment
Scope:
p
Medical products designed for medical application in the
territory of the Russian Federation which are designed for:
- preventive treatment, diagnostics (in vitro), sickness treatment,
after-care treatment, medical procedures, medical research,
replacement and modification of parts of human body tissues,
organs,
organs recovery or compensation of disrupted or lost
physiological functions, impregnation control;
- production of effect on human organism so that their designated
purpose is not implemented through chemical, pharmacological,
immunological or metabolic interaction with human organism, but
of which effect can be supported by such means.
42
www.intertek.com

43. Country: Russia
Step 3
p
43
Device Classification
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44. Step 3: Device Classification
Confirm classification of your device using Roszdravnadzor Order No.
y
g
735 and Rosstandart 51609-2000.
Define the type of the medical device according to Decree No. 4n
Class I – low-risk
Class IIa – medium risk
Class IIb – increased risk
Class III – high-risk
Search for equivalent medical devices already
approved for sale in the Russian Federation.
44
This classification system
is equivalent to that of EU
and comparable to that of
U.S. FDA.
This is similar to the U.S.
FDA 510(k) or Premarket
Notification wherein
substantial equivalence is
to be claimed to previously
cleared device (predicate
device)
www.intertek.com

45. Country: Russia
Step 4
p
45
In-Country
In Country
Representation
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46. Step 4: In-Country Representation
Appoint an Authorized Regulatory representative to co-ordinate the
pp
g
y p
registration process in Russia
Only needed for devices classified as Class IIa IIb and III.
For Class I devices, skip to Step 5.
Similar to EU - Companies without a
location in Europe must appoint an
Authorized Representative to act on
their behalf
Difference (w.r.t U.S.) - If located
outside the U.S., an “US Agent” must
be appointed and the company and
device should be registered. No
certificate is issued by FDA but
company is subject to random FDA
inspections for QSR compliance.
46
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47. Country: Russia
Step 5
p
47
Registration
Requirements
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48. Step 5: Registration Requirements
Meet with officials to determine the testing
g
requirements for the device
Submit a application for permission to import testing
samples
Conduct testing at government authorized testing and
medical centers within R
di l
t
ithi Russia
i
Receive results of testing and medical reports
Apply for Regulatory Approval
48
This process is quite
p
q
different compared to
U.S. regulatory
processes, where most
Class I devices are
exempt from PreMarket
Notifications, most
Class II and some Class
III devices are subject
to FDA 510(k); and most
Class III devices are
subject to PMA
Russia's process is
also different from EU;
where a Technical File
is typically needed for
all device classes.
www.intertek.com

49. Step 5: Registration Requirements
Testing must be p
g
performed by local expertise
y
p
centers and hospitals and the results must be
included in the registration dossier.
All applicable quality, safety and efficacy testing
should be performed at Authorized Expertise
Centers and Hospitals in Russia.
49
The testing requirements
g q
differ from EU and U.S.,
where testing to harmonized
standards is generally
accepted. So, the biggest
hurdle for foreign
manufacturers seeking
device registration /
approval in Russia is that it
relies on a system of
product testing as a tool for
determining safety and
efficacy. Such testing is
also required for products
that already possess CE
marking, U.S. Food and
Drug Administration 510(k)
clearance or other national
approval.
www.intertek.com

50. Country: Russia
Step 6
p
50
Preparation &
Submission
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51. Step 6: Preparation & Submission
Prepare a Registration Dossier that includes all technical details
p
g
about your device, including testing results.
Proof of home country approval must also be obtained using a CFS
(Certificate of Free Sale) or CFG (Certificate to Foreign
Government).
Submit dossier and CFS or CFG to
Roszdravnadzor.
**All technical doc ments m st be s bmitted in
documents must
submitted
Russian.
51
The requirement to have
testing requirements
conducted in Russia is
stringent compared to U.S.
FDA and EU Regulatory
approval process
www.intertek.com

52. Step 6: Preparation & Submission
If the dossier is approved, Roszdravnadzor issues a Registration
pp
,
g
Certificate.
To clear medical devices through Russian Customs, products must have
one or both of the following certificates (which can only be issued after
the Registration Certificate has been obtained):
• S it
Sanitary-Epidemiological C
E id i l i l Conclusion (H i
l i (Hygiene C tifi t )
Certificate)
• GOST-R Quality Certificate
Apply for a Declaration of Conformity (DoC) certificate
52
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53. Country Profile: India
• 1.26 billion population
• 1.6% annual population g
p p
growth
rate
• 400 million middle income
consumers in India
• $35 billion - value of India’s
healthcare market in 2011
• $2.7 billion - value of India’s
medical device market in 2011
de ice
• 15.6% Growth of India’s medical
device market
Source: U.S. Commercial Service, ReporterLinker
53
www.intertek.com

54. Country: India
Step 1
p
54
Regulatory Background
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55. Step 1: Regulatory Background
Import, manufacture, sale and distribution of medical devices are
p ,
,
regulated in India under the provisions of the Drugs & Cosmetic Act
1940 & Rules 1945.
The Central Drugs Standard Control Organization (CDSCO) is the
national regulatory body for Indian pharmaceuticals and medical
devices.
55
www.intertek.com

56. Country: India
Step 2
p
56
Product Assessment
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57. Step 2: Product Assessment
Instruments, equipment, tools, materials and other objects,
, q p
,
,
j
,
including the software attached to them, that are designed to
be used either independently or in combination on human
body.
1.Prevention, diagnosis, treatment, monitoring or remission
of diseases
2. Diagnosis, treatment, monitoring, remission or
compensation of injury or physical disability
3.Research, replacement or adjustment of anatomical or
j
physiological process
4. Control of pregnancy
Source: http://eng.sfda.gov.cn/WS03/CL0767/61641.html
57
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58. Country: India
Step 3
p
58
Device Classification
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59. Step 3: Device Classification
Identify if the device is in the list of "Notified Medical Devices" or
y
IVD's that require medical device Registration in India
Note: In case of an IVD that is not on the list of regulated
products, skip to Step 5
List of Notified Medical Devices:
http://cdsco.nic.in/List%20of%20Notified%20Medical%20devices.pdf
p
p
59
www.intertek.com

60. Country: India
Step 4
p
60
In-Country
In Country
Representation
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61. Step 4 In-Country Representation
If the device is regulated, an India Authorized Agent should be
g
,
g
appointed to interact with CDSCO.
Appoint an agent responsible for pre-certification and post-market
surveillance inquiries.
The authorized agent must maintain a drug wholesale license and be
a resident of India OR maintain a place of b i
id t f I di
i t i
l
f business th
there.
61
www.intertek.com

62. Country: India
Step 5
p
62
Registration
Requirements
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63. Step 5: Registration Requirements
Only notified medical devices are regulated in India. The
y
g
following medical devices are notified under the Drugs and
Cosmetics Act.
• Catheters, hear valves, cardiac stents, etc.
For import of medical devices, the manufacturing site and
products are required t b registered.
d t
i d to be
i t d
Guidelines and FAQ on Registration and Import of Medical Devices in India
http://cdsco.nic.in/FAQIMPORT%20&%20REGISTRATION%2002022013_DONEE.pdf
63
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64. Country: India
Step 6
p
64
Preparation &
Submission
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65. Step 6: Preparation & Submission
File your application for device registration (
y
pp
g
(Form 41)
)
Identify distributor in India and file application for Import license
(Form 10)
65
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66. Country Profile: Japan
$29.8 billion Medical Device Market in 2013
g
Second Largest Medical Device Market
behind the U.S.
Growth rate 2.5% through 2018
p
;
p p
Population 127.2 Million; 10th most populated
country in the world
Aging population with 23% 65 or older
p
p
$3,958,
,
Per capita healthcare expenditure is $ ,
8.5% GDP
66
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67. Country: Japan
Step 1
p
67
Regulatory Background
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68. Step 1: Regulatory Background
Pharmaceuticals and Medical Devices Agency (
g
y (PMDA)
)
Pharmaceutical Affairs Law (PAL)
PMDA is the Japanese regulatory agency working together with the
Ministry of Health, Labor and Welfare to protect the public health by
assuring safety, efficacy and quality of pharmaceuticals and medical
devices.
PAL covers regulations on pharmaceuticals, medical devices and
cosmetics.
68
www.intertek.com

69. Country: Japan
Step 2
p
69
Product Assessment
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70. Country: Japan
Step 3
p
70
Device Classification
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71. Step 3: Device Classification
Determine device classification according to Japanese PAL
g
p
and JMDN codes.
Class I - General Medical Devices
Potential risk is almost insignificant in case of malfunction or side
effect. Examples: scalpel, X-Ray film, etc.
Class II - Specified Controlled Medical Devices
Class II - Controlled Medical Devices
Having potential risk in case of malfunction or side effect.
Examples: MRI, electronic sphygmomanometers, etc.
Class III - Highly Controlled Medical Devices
Class IV - Highly Controlled Medical Devices
Potential risk is significant in case of malfunction or side effect.
g
Examples: Dialyzer, pacemaker, stent, etc.
71
The classification
system is significantly
t
i i ifi
tl
different when
compared to U.S. and
EU where devices are
classified into Class I,
,
II and III
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72. Country: Japan
Step 4
p
72
In-Country
In Country
Representation
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73. Step 4: In-country Representation
Appoint Marketing Authorization Holder (
pp
g
(MAH or D-MAH) to
)
manage and control the device registration in Japan.
MAH and D-MAH Requirements
• Must be based in Japan
• Must be formally licensed by the prefecture of residence
• Must employ at least three staff members: general manager,
p y
g
g ,
quality manager and safety manager
• Must implement GQP and GVP systems
73
The MAH and D-MAH has
much more legal, logistic
and regulatory
responsibility compared to
European Authorized
Representative or an U.S.
FDA Agent.
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74. Country: Japan
Step 5
p
74
Registration
Requirements
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75. Step 5: Registration Requirements
To market medical devices in Japan, the MAH must register the
p ,
g
device through the following procedures.
• Pre-market Submission (Todokede)
• Pre-market Certification (Ninsho)
• Pre-market Approval (Shonin)
75
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76. Country: Japan
Step 6
p
76
Preparation &
Submission
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77. Step 6: Preparation & Submission
Class I - General Medical Devices
•Submit Pre-Market Submission to PMDA.
•Self-declaration with no assessment or certificate issued by
PMDA
77
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78. Step 6: Preparation & Submission
Class II - Specified Controlled Medical Devices
p
•Submit Pre-Market Certification application to a
Registered Certified Body (RCB) authorized to issue
certifications.
•Involves QMS audit and certificate issuance by RCB.
The Pre-market Certification
(Ninsho) is quite similar to
European CE Marking using a
Notified Body. Each Specified
Controlled Medical Device must
apply internationally harmonized
standards as is the case with CE
Marking
78
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79. Step 6: Preparation & Submission
Class II - Controlled Medical Devices
Class III - Highly Controlled Medical Devices
Class IV - Highly Controlled Medical Devices
•Prepare Pre-Market Approval application as well as
registration dossier in Summary Technical Document
(STED) f
format. S b it d
t Submit documents t PMDA
t to PMDA.
•Involves QMS audit by PMDA. On-site audits required for
y
new devices, as well as Class IV devices and those
requiring clinical investigations.
79
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80. And more…
• We have the expertise and global
resources to get you exactly where
you need to be – wherever you
want to go.
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81. Want More?
Download the audio recording to accompany these slides
www.intertek.com/medical/events/gma-webinar-2013
i t t k
/ di l/
t /
bi
2013
If you h
have questions about a specific device that you are
ti
b t
ifi d i th t
looking to bring to new markets, contact us directly.
icenter@intertek.com
81
1-800-WORLDLAB
www.intertek.com