6 steps to global markets

SIX STEPSt A Gl b lto Access Global Medical Device MarketsOctober, 2013

Justin Heyl Consulting Program Manager at IntertekJustin Heyl, Consulting Program Manager at Intertek

Bhavesh Sheth, Consultant

www.intertek.com1

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 i th h t th i10 companies throughout their development cycles to expedite market access on a global scale.

www.intertek.com2

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,

f t f i k l isafety, performance, risk analysis, biocompatibility, sterilization, and labeling of medical devices, Bhavesh’s regulatory expertise willBhavesh s regulatory expertise will help you avoid project delays and meet your business goals.

www.intertek.com3

An Extensive Global Network

• Leading quality solutions provider

• Origins back to 1885 g

• Market Capitalisation > £5bn

• 2012 Sales £2.0bn, EBITA £335m (16.3%) 1,000

More than

( )

• 9.0% Average FY Organic Revenue growth 2002-12 100

More than

countries

laboratoriesand offices

36,000,people

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Where do you want to go?

Russia

JapanIndia

China

Brazil

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Here’s how to get where you want to go.

Six Steps to Global Markets1.Regulatory Background

2.Product Assessment

3.Device Classification

4.In-Country Representation

5.Registration Requirementsg q

6.Preparation & Submission

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Country Profile: China

• By 2015, Medtech Market Projected to be $11.4 billion vs. U.S. $160B vs. Europe $115B

$• Medical Device Market $9 billion

• 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 areimportedimported

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Country: China

Step 1Regulatory Background

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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 ibl f i i d d i i t ti f di lIt is responsible for supervision and administration of medical devices in China.

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Country: China

Step 2Product Assessment

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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 Di i t t t it i i i ti2. Diagnosis, treatment, monitoring, remission or compensation of injury or physical disability

3 Research replacement or adjustment of anatomical or3.Research, replacement or adjustment of anatomical or physiological process

4 Control of pregnancy

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4. Control of pregnancySource: http://eng.sfda.gov.cn/WS03/CL0767/61641.html

Country: China

Step 3Device Classification

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Step 3: Device Classification

Class I - Devices for which safety and effectiveness can be ensured ythrough 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

The classification system i i il t EU d U SCl III Hi h i k d i h th is similar to EU and U.S. in that there are 3 device

classes. However, a Class II device in the US or Class IIa/IIb device in

Class III – High-risk devices such as 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 the EU may be classified

as Class III in China.

potential risk to the human body (products such as implanted artificial internal organs and infant care devices)

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Source: http://eng.sfda.gov.cn/WS03/CL0767/61641.html

Country: China

In CountryStep 4 In-Country Representation

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Step 4: In-country Representation

Appoint a "Legal Agent and After Sales Agent" to co-ordinate pp g g gCFDA 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 yearsprocess 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

i li ti f th d i i Chicommercialization of the device in China.

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Country: China

RegistrationStep 5 Registration Requirements

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Step 5: Registration Requirements

P d b it li ti t CFDA f I t M di l D iPrepare and submit an application to CFDA for an Import Medical Device Registration Certificate (IMDRC).

Proof of registration in country of origin is required Thi i diff tProof of registration in country of origin is required. This is different compared to U.S and

EU, where device approvals and

registration are strictly g ybased on the

evaluation carried out by FDA or Notified

Bodies.

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Submit the device to CFDA for testing. Testing is carried out by the CFDA g g yMedical 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 d t tl t d d l l i ti ti ld b t d idata are mostly accepted and local investigation could be exempted in most circumstances.

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China Compulsory Certification (CCC) is applicable to some medical p y ( ) ppdevices 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.

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Country: China

Preparation &Step 6 Preparation & Submission

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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

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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• 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).

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Country Profile: Brazil

• Medical device market valued at nearly $5.9 billion.

• Population growing at .9% annuallyp g g y

• 6.7% of population 65 or older

• Per capita health care expenditure $1,121

• T t l dit h lth % f GDP 8 9%• Total expenditure on health as a % of GDP: 8.9%

• Total population: 199,000,000

• Medical device imports $2.8bn in 2012.

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Country: Brazil


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Medical devices in Brazil are regulated by the National Health g ySurveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA)

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Country: Brazil


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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, maymetabolic means to perform their main function to humans, may however be assisted in his duties by such means.

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Country: Brazil


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Device Classification System:4 d i l th

y

• Class I• Class II

4 device classes means the classification system is slightly different from

U.S. FDA

• Class III• Class IV

Cl I d II i l d l d di i k

However, Brazilian Resolution RDC 185/01 is designed similarly to the European Medical Device

Directive (93/42/EEC)Class I and II include low and medium risk devices. Class III and IV include higher-risk devices

Directive (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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Country: Brazil


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Step 4: In-Country Representation

Appoint a company that holds a Company Similar to EU - Companies pp p y p yWorking Allowance permit from ANVISA as the Brazil Registration Holder (BRH).

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.compliance.

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Country: Brazil


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It is mandatory to register all medical devices listed in RDC No. y g185, 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 The Registration requirements are

similar to EU and U.S. in that all devices have

to be registered.

registration certificate proving home-country approval

- OR – to be registered.

Demonstrate evidence of registration in two other markets and justify why the device does not have home country approval

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home-country approval.


Certain devices require INMETRO Certification, including medical q , gdevices sold in Brazil that fall under the scope of the following standards:

• NBR IEC 60601 series• NBR IEC 60601 series• NBR ISO 6875:1998: Dental patient chair• NBR ISO 7785-2:2004: Dental handpieces – Part 2: Straight and geared angle handpieces

This process is quite similar to EU and U.S.

FDA's test data evaluation and policy

of accepting test

g g 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 i f di l of accepting test reports• NBR ISO 11195:2000: Gas mixers for medical use –

Stand-alone gas mixers• NBR ISO 8835-2:2010: Inhalational anaesthesia systems – Part 2: Anaesthetic breathing systems

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Country: Brazil


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Submit the registration application and Technical File to ANVISA g ppthrough BRH. ANVISA reviews registration application.

Technical files required by ANVISA resembleHigh-risk and innovative devices must meet ANVISA resemble

documents required by the U.S. FDA.

Applicants that have

gANVISA clinical trial requirements. ANVISA usually accepts clinical trial results previously conducted in other markets as adequate to

already prepared Technical Files for CE

Marking or U.S. FDA 510(k) submissions may usually

reuse similar information to

meet such requirements.

reuse similar information to prepare their Brazilian

Technical Files.

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Once approved, ANVISA will publish registration number in the Diáriopp , p gOficial da União (DOU).

Note: Both ANVISA device registrations and INMETRO certifications must be renewed every five years

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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

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Source: U.S. Commercial Service, ReporterLinker

Country: Russia


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Roszdravnadzor (Federal Service for Control of Healthcare and (Social Development in the Russian Federation) oversees all domestic and imported medical devices in Russia.

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Country: Russia


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Scope:pMedical 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 recovery or compensation of disrupted or lostorgans, 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.

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Country: Russia


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Confirm classification of your device using Roszdravnadzor Order No. y g735 and Rosstandart 51609-2000.

Define the type of the medical device according to Decree No. 4n

Class I – low-riskClass IIa – medium risk

This classification system is equivalent to that of EU and comparable to that of Class IIa medium risk

Class IIb – increased riskClass III – high-risk

U.S. FDA.

This is similar to the U.S. FDA 510(k) or Premarket

Notification whereinSearch for equivalent medical devices already approved for sale in the Russian Federation.

Notification wherein substantial equivalence is to be claimed to previously cleared device (predicate

device)

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Country: Russia


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Step 4: In-Country Representation

Appoint an Authorized Regulatory representative to co-ordinate the pp g y pregistration 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 andbe 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.

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Country: Russia


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Meet with officials to determine the testing This process is quite grequirements for the device

Submit a application for permission to import testing

p qdifferent compared to

U.S. regulatory processes, where most

Class I devices are exempt from PreMarketsamples

Conduct testing at government authorized testing and di l t ithi R i

exempt from PreMarketNotifications, most

Class II and some Class III devices are subject

to FDA 510(k); and most medical centers within Russia

Receive results of testing and medical reports

Class III devices are subject to PMA

Russia's process is also different from EU;

Apply for Regulatory Approvalalso different from EU; where a Technical File is typically needed for

all device classes.

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Testing must be performed by local expertise The testing requirements g p y pcenters and hospitals and the results must be included in the registration dossier.

g qdiffer from EU and U.S.,

where testing to harmonized standards is generally

accepted. So, the biggest hurdle for foreignAll applicable quality, safety and efficacy testing

should be performed at Authorized Expertise Centers and Hospitals in Russia.

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 CEthat already possess CE marking, U.S. Food and

Drug Administration 510(k) clearance or other national

approval.

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Country: Russia


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Prepare a Registration Dossier that includes all technical details p gabout 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).

The requirement to have testing requirements

conducted in Russia is stringent compared to U.S.

FDA and EU Regulatory

Submit dossier and CFS or CFG to Roszdravnadzor.

**All technical doc ments m st be s bmitted in FDA and EU Regulatory approval process**All technical documents must be submitted in

Russian.

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If the dossier is approved, Roszdravnadzor issues a Registration pp , gCertificate.

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 E id i l i l C l i (H i C tifi t )• Sanitary-Epidemiological Conclusion (Hygiene Certificate)• GOST-R Quality Certificate

Apply for a Declaration of Conformity (DoC) certificateApply for a Declaration of Conformity (DoC) certificate

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Country Profile: India

• 1.26 billion population

• 1.6% annual population growth p p grate

• 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 de ice market in 2011medical device market in 2011

• 15.6% Growth of India’s medical device market

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Source: U.S. Commercial Service, ReporterLinker

Country: India


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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.

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Country: India


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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 diseases2. Diagnosis, treatment, monitoring, remission or compensation of injury or physical disability3.Research, replacement or adjustment of anatomical or jphysiological process4. Control of pregnancy

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Source: http://eng.sfda.gov.cn/WS03/CL0767/61641.html

Country: India


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Identify if the device is in the list of "Notified Medical Devices" or yIVD'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.pdfp p

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Country: India


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Step 4 In-Country Representation

If the device is regulated, an India Authorized Agent should be g , gappointed 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 id t f I di OR i t i l f b i tha resident of India OR maintain a place of business there.

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Country: India


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Only notified medical devices are regulated in India. The y gfollowing 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 d t i d t b i t dproducts are required to be registered.

Guidelines and FAQ on Registration and Import of Medical Devices in India

http://cdsco.nic.in/FAQ-IMPORT%20&%20REGISTRATION%2002022013_DONEE.pdf

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Country: India


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File your application for device registration (Form 41)y pp g ( )

Identify distributor in India and file application for Import license (Form 10)

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Country Profile: Japan

$29.8 billion Medical Device Market in 2013

Second Largest Medical Device Market gbehind the U.S.

Growth rate 2.5% through 2018

Population 127.2 Million; 10th most populated p ; p pcountry in the world

Aging population with 23% 65 or older

Per capita healthcare expenditure is $3,958, p p $ , ,8.5% GDP

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Country: Japan


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Pharmaceuticals and Medical Devices Agency (PMDA)g y ( )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.

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Country: Japan


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Country: Japan


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Determine device classification according to Japanese PAL g pand JMDN codes.

Class I - General Medical DevicesPotential risk is almost insignificant in case of malfunction or side effect. Examples: scalpel, X-Ray film, etc.

Class II - Specified Controlled Medical Devices The classification t i i ifi tlClass II Specified Controlled Medical Devices

Class II - Controlled Medical DevicesHaving potential risk in case of malfunction or side effect. Examples: MRI, electronic sphygmomanometers, etc.

system is significantly different when

compared to U.S. and EU where devices are classified into Class I,

Class III - Highly Controlled Medical DevicesClass IV - Highly Controlled Medical DevicesPotential risk is significant in case of malfunction or side effect.

,II and III

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gExamples: Dialyzer, pacemaker, stent, etc.

Country: Japan


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Step 4: In-country Representation

Appoint Marketing Authorization Holder (MAH or D-MAH) to pp g ( )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 The MAH and D-MAH has

much more legal, logistic and regulatoryand regulatory

responsibility compared to European Authorized

Representative or an U.S. FDA Agent.

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Country: Japan


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To market medical devices in Japan, the MAH must register the p , gdevice through the following procedures.

• Pre-market Submission (Todokede)• Pre-market Certification (Ninsho)• Pre-market Approval (Shonin)

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Country: Japan


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Class I - General Medical Devices•Submit Pre-Market Submission to PMDA.•Self-declaration with no assessment or certificate issued by PMDAPMDA

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Class II - Specified Controlled Medical Devicesp•Submit Pre-Market Certification application to a Registered Certified Body (RCB) authorized to issue certifications.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

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Class II - Controlled Medical DevicesClass III - Highly Controlled Medical DevicesClass IV - Highly Controlled Medical Devices

•Prepare Pre-Market Approval application as well as registration dossier in Summary Technical Document (STED) f t S b it d t t PMDA(STED) format. Submit documents to PMDA.

•Involves QMS audit by PMDA. On-site audits required for ynew devices, as well as Class IV devices and those requiring clinical investigations.

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And more…

• We have the expertise and globalWe have the expertise and global resources to get you exactly where you need to be – wherever you want to go.

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Want More?

Download the audio recording to accompany these slides

i t t k / di l/ t / bi 2013www.intertek.com/medical/events/gma-webinar-2013

If h ti b t ifi d i th tIf you have questions about a specific device that you arelooking to bring to new markets, contact us directly.

[email protected] 1-800-WORLDLAB

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