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.
Rules and regulations for medical device registration, forms and fees required, types of medical devices to be registered under CDSCO India.
Indian market overview
India’s medical device regulatory structure
Categories of regulated medical devices in India
No Objection Certificates
Device Registration Certificate applications
Import Licensing
India Authorized Agent selection
Costs and Timelines
Developing Regulatory Issues in India
Changes in the pipeline for the traceability of medical devices and equipment. Unique Device Identification, Global Medical Device Nomenclature, barcodes and more!
Medical Devices Rules 2017 Implementationshashi sinha
Medical Devices Rules are now enforced for all medical devices. It is important to know about the MDR 2017 and how it affects the Manufacturers, Importers and Distributors of Medical Devices and status of implementation.
Nowadays, health is given much priority in all aspects. The present
generation is very much conscious about having periodic checkups
and maintaining a good health. This awareness has given an upper
hand to the medical equipment business. The healthcare industry is
booming like no other field and because of this, Medical Device
Regulation India has also become equally complicated. Unlike
previous years, nowadays most medical devices are required to be
registered and need approval for business
Medical device as per india and usa special reference with 510(k)vikash vyas
1. medical device as per usa:
a) classification
b) 510(k)
c) 510(k) submission process
d) pre market approval(PMA)
2. medical device as per india
a) definition
b) organization of medical device reviewer
c) registration process
d) document required for the registration of medical device as per cdsco
Understanding FDA Requirements Medical Devicesmarchell
The medical device market is experiencing explosive growth. Currently valued at $90 billion, market growth will continue to accelerate as demographics and market drivers increase their pressure for new and innovative product offerings.
Moreover, a substantial investment of time and resources is required to properly evaluate a new product idea and estimate its potential for success. So when a company executive declines a seemingly good product idea, what is probably being declined is the expense of properly evaluating the idea, and after having paid these expenses, the prospect of embarking on an expensive commercialization effort that has a 90 percent chance of failing.
Device registration and listing of medical devices on the US marketttopstart B.V.
We provide an overview of the regulations and legislations with regard to commercialisation of medical devices in the US. The product category of medical devices ranges from class I devices up to class III devices. In the US, market approval is granted by the FDA (Food and Drug Administration) upon assessment of quality, safety and effectiveness.
The information provided here informs start-ups, spin-offs and biotech companies about the differences in regulatory procedures for specific classes of medical devices. By summarising the procedures for each class of medical device, we, ttopstart, aim to offer a guide through this dense regulative and legislative landscape. These insights can be used to design the optimal market introduction strategy for your medical device.
Rules and regulations for medical device registration, forms and fees required, types of medical devices to be registered under CDSCO India.
Indian market overview
India’s medical device regulatory structure
Categories of regulated medical devices in India
No Objection Certificates
Device Registration Certificate applications
Import Licensing
India Authorized Agent selection
Costs and Timelines
Developing Regulatory Issues in India
Changes in the pipeline for the traceability of medical devices and equipment. Unique Device Identification, Global Medical Device Nomenclature, barcodes and more!
Medical Devices Rules 2017 Implementationshashi sinha
Medical Devices Rules are now enforced for all medical devices. It is important to know about the MDR 2017 and how it affects the Manufacturers, Importers and Distributors of Medical Devices and status of implementation.
Nowadays, health is given much priority in all aspects. The present
generation is very much conscious about having periodic checkups
and maintaining a good health. This awareness has given an upper
hand to the medical equipment business. The healthcare industry is
booming like no other field and because of this, Medical Device
Regulation India has also become equally complicated. Unlike
previous years, nowadays most medical devices are required to be
registered and need approval for business
Medical device as per india and usa special reference with 510(k)vikash vyas
1. medical device as per usa:
a) classification
b) 510(k)
c) 510(k) submission process
d) pre market approval(PMA)
2. medical device as per india
a) definition
b) organization of medical device reviewer
c) registration process
d) document required for the registration of medical device as per cdsco
Understanding FDA Requirements Medical Devicesmarchell
The medical device market is experiencing explosive growth. Currently valued at $90 billion, market growth will continue to accelerate as demographics and market drivers increase their pressure for new and innovative product offerings.
Moreover, a substantial investment of time and resources is required to properly evaluate a new product idea and estimate its potential for success. So when a company executive declines a seemingly good product idea, what is probably being declined is the expense of properly evaluating the idea, and after having paid these expenses, the prospect of embarking on an expensive commercialization effort that has a 90 percent chance of failing.
Device registration and listing of medical devices on the US marketttopstart B.V.
We provide an overview of the regulations and legislations with regard to commercialisation of medical devices in the US. The product category of medical devices ranges from class I devices up to class III devices. In the US, market approval is granted by the FDA (Food and Drug Administration) upon assessment of quality, safety and effectiveness.
The information provided here informs start-ups, spin-offs and biotech companies about the differences in regulatory procedures for specific classes of medical devices. By summarising the procedures for each class of medical device, we, ttopstart, aim to offer a guide through this dense regulative and legislative landscape. These insights can be used to design the optimal market introduction strategy for your medical device.
This short presentation is giving a brief introduction of the general status of china medial device industry, as well as an explanation about the CFDA and the medical registration process in china
This whitepaper provides an overview of Chinese Medical Device Regulations. This includes an overview of the Chinese medical device market, medical device regulatory authorities, medical device registration procedure and medical device classification. It also provides information on regulations regarding product standard, type testing, and clinical trials. This paper is meant for anyone within the regulatory affairs industry who is looking to learn more about medical device regulations and product registration in China.
For more information, contact us for a free 15 minute consultation at http://www.pacificbridgemedical.com/contact-us/.
Japan PMDA Medical Device Regulatory Approval ProcessEMERGO
Watch the recorded webinar: https://www.emergogroup.com/resources/video-webinar-japan-registration-process
Japan's medical device market is one of the most robust markets in Asia, but its regulatory system can be confusing. Before deciding to sell your device in the Japanese market, it is important to understand how the regulations apply to your device, which steps to take, and what resources are required to complete the process. In this presentation, Ann Marie Boullie, Vice President of Business Development for EMERGO, will discuss some of the most complex aspects of the Japanese registration process, including:
JMDN codes: device classification and predicates
Clinical data requirements and PMDA pre-submission meetings
Registration routes (Todokede, Ninsho, Shonin)
QMS (Ordinance 169) requirements
Role of the Marketing Authorization Holder (MAH)
Plus more ...
India’s Medical Device Regulatory LandscapeEMMAIntl
India’s medical device market is growing exponentially. The medical device industry in India is presently valued at $5.2 Billion and is growing at 15.8% CAGR. Currently, India is considered among the top 20 global medical device markets and is the 4th largest medical device market in Asia after Japan, China, and South Korea...
UDI: What & How within the overall Medical Device value chainnancykathlen
Free Webinar on Unique Device Identification (UDI): What & How within overall Medical Device Value Chain June 18th 2015. This webinar provides insights into various aspects of UDI, discuss the operational aspects of implementing and integrating UDI within the overall Medical Device value chain.
Overview and update of chinese medical device regulationCIRS China
In this presentation, it interprets the latest changes of China's medical device regulations which involves UDI, MAH, etc. and provide practical advices for overseas medical device enterprises to register and marketing in China under the new regulations.
If you are selling medical devices in the US, your devices are subject to new regulatory requirements under the FDA Unique Device Identification (UDI) rule.
UL experts have been actively working with customers with gap assessments, project planning and more to support compliance with these requirements. In this webinar, Ms. Linda Chatwin, RAC will be sharing some of our key learnings.
UL offers a full suite of services to support compliance with FDA's UDI Rule.
For more information, please contact us and request a sell sheet at Medical.Inquiry@ul.com, visit our UDI webpage or speak directly with one of our experts at 1-877-854-3577 or +91 804 138 4434
http://industries.ul.com/blog/us-fda-unique-device-identification-udi-implementation-deadline-in-place-for-medical-devices
To import Drug into India, the Site of manufacturing & products are to be registered.We give Services in getting manufacturing licences
ACCREDITED CONSULTANTS PVT.LTD
info@acplgroupindia.co.in
+919310040434
This short presentation is giving a brief introduction of the general status of china medial device industry, as well as an explanation about the CFDA and the medical registration process in china
This whitepaper provides an overview of Chinese Medical Device Regulations. This includes an overview of the Chinese medical device market, medical device regulatory authorities, medical device registration procedure and medical device classification. It also provides information on regulations regarding product standard, type testing, and clinical trials. This paper is meant for anyone within the regulatory affairs industry who is looking to learn more about medical device regulations and product registration in China.
For more information, contact us for a free 15 minute consultation at http://www.pacificbridgemedical.com/contact-us/.
Japan PMDA Medical Device Regulatory Approval ProcessEMERGO
Watch the recorded webinar: https://www.emergogroup.com/resources/video-webinar-japan-registration-process
Japan's medical device market is one of the most robust markets in Asia, but its regulatory system can be confusing. Before deciding to sell your device in the Japanese market, it is important to understand how the regulations apply to your device, which steps to take, and what resources are required to complete the process. In this presentation, Ann Marie Boullie, Vice President of Business Development for EMERGO, will discuss some of the most complex aspects of the Japanese registration process, including:
JMDN codes: device classification and predicates
Clinical data requirements and PMDA pre-submission meetings
Registration routes (Todokede, Ninsho, Shonin)
QMS (Ordinance 169) requirements
Role of the Marketing Authorization Holder (MAH)
Plus more ...
India’s Medical Device Regulatory LandscapeEMMAIntl
India’s medical device market is growing exponentially. The medical device industry in India is presently valued at $5.2 Billion and is growing at 15.8% CAGR. Currently, India is considered among the top 20 global medical device markets and is the 4th largest medical device market in Asia after Japan, China, and South Korea...
UDI: What & How within the overall Medical Device value chainnancykathlen
Free Webinar on Unique Device Identification (UDI): What & How within overall Medical Device Value Chain June 18th 2015. This webinar provides insights into various aspects of UDI, discuss the operational aspects of implementing and integrating UDI within the overall Medical Device value chain.
Overview and update of chinese medical device regulationCIRS China
In this presentation, it interprets the latest changes of China's medical device regulations which involves UDI, MAH, etc. and provide practical advices for overseas medical device enterprises to register and marketing in China under the new regulations.
If you are selling medical devices in the US, your devices are subject to new regulatory requirements under the FDA Unique Device Identification (UDI) rule.
UL experts have been actively working with customers with gap assessments, project planning and more to support compliance with these requirements. In this webinar, Ms. Linda Chatwin, RAC will be sharing some of our key learnings.
UL offers a full suite of services to support compliance with FDA's UDI Rule.
For more information, please contact us and request a sell sheet at Medical.Inquiry@ul.com, visit our UDI webpage or speak directly with one of our experts at 1-877-854-3577 or +91 804 138 4434
http://industries.ul.com/blog/us-fda-unique-device-identification-udi-implementation-deadline-in-place-for-medical-devices
To import Drug into India, the Site of manufacturing & products are to be registered.We give Services in getting manufacturing licences
ACCREDITED CONSULTANTS PVT.LTD
info@acplgroupindia.co.in
+919310040434
Strategies for Device Approval in China, India, South Korea and AustraliaApril Bright
This session will describe the orthopaedic device regulatory and registration requirements in Asia Pacific markets. Regulatory steps and strategies will be presented for each of these countries. The discussion will also cover ways to gain regulatory information about competitors already selling in these markets. Attendees will leave the session with an understanding of timelines, costs and complexity for approval.
Regulation Governing Clinical Trials In India,USA and Europe. KapilKumar198
This presentation contain detailed information about the "Regulation Governing Clinical Trials In India,USA and Europe".And about the clinical trails and medical devices regulations in India.
“CFDA Registration – Market Access Before Investment” delivered by Tim Lin, T...ulmedical
Due to a large population, increasing middle class and government plans to build tens of thousands of hospitals, there is a lot of demand for high quality medical devices in China. For many foreign medical device manufacturers, the regulatory barriers are still significant obstacles.
The medical device regulation in China is less harmonized and generally unique from other major markets. The primary challenges tend to be: actual testing, drafting standards, language barriers and license parking. These additional requirements create a delay in the registration process.
Foreign manufacturers need to specifically understand the Chinese medical device regulation in advance, and then are able to determine appropriate strategies aimed at successful China market entry.
This is the content for a live webinar, "CFDA Registration, Market Access before Investment...Solving the CFDA Challenge" delivered by UL's Tim Lin. Tim is the Senior Technical Consultant working in the Greater China Region. He majored in public health and medical device engineering, and worked as a reviewer in the Taiwan FDA for high and moderate-risk medical device and clinical trial protocol for over 5 years; and also drafted guidance for industry. He is now responsible for risk management file, usability engineering, software validation and CE MDD technical documentation.
Medical devices: 7 steps to CE-mark, and post-market surveillanceChristian Johner
The 7 steps medical device manufacturers have to take to fulfill the requirements of EU-MDR (medical medical device regulation) and to obtain the CE mark. The quick start guide.
introduction, classification, regulatory approval process for medical devices (510k) premarket notification, pre market approval (PMA), investigational device exemption (IDE) and invitro diagnostics, quality system requirements 21 CFR PART 820, labeling requirements 21 CFR part 801, UDI
Medical device and Patency
By MDD 93/42
Any devices including an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings or animals which does not achieve the primary intended action in or on human body or animals by any pharmacological or immunological or metabolic means, but which may assist in its intended function by such means for one or more of the specific purposes of ―
diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder;
diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability;
investigation, replacement or modification or support of the anatomy or of a physiological process;
supporting or sustaining life;
disinfection of medical devices; and
control of conception.
What is 510(k) ?
A 510(k) is a premarket submission made to FDA to demonstrate
that the device to be marketed is as safe and effective, that is,
substantially equivalent, to a legally marketed device
(section 513(i)(1)(a) FD&C act).
Medical Devices are notified as DRUGS under Drugs & Cosmetics Act. Section 3 (b) (iv) defines,
Medical Devices as “Devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals”
India had no regulation for medical devices in place prior to 2005.
The import, manufacturing, distribution and Sale of medical devices in India are overseen by the Drugs and Cosmetics Act (1940) and Rules (1945)
Control and inspection are carried out by the CDSCO, state drug controllers and central/state laboratories.
Many emerging companies make the mistake of putting all of their resources into immediate needs, and often neglect longterm regulatory strategy concerns when it comes to submissions and approvals. Don’t neglect the strategy piece in your planning! This lunch will provide a deep-dive foundation of how to develop a regulatory strategy. Topics to be addressed include:
What are different types of regulatory submissions for devices?
What are current trends in regulatory agencies?
What regulations around devices affect your organization?
Attendees will have the opportunity to ask questions with their company’s needs in mind.
Join us and Halloran Consulting at M2D2 for this expert lunch. Food will be served.
What is the TDS Return Filing Due Date for FY 2024-25.pdfseoforlegalpillers
It is crucial for the taxpayers to understand about the TDS Return Filing Due Date, so that they can fulfill your TDS obligations efficiently. Taxpayers can avoid penalties by sticking to the deadlines and by accurate filing of TDS. Timely filing of TDS will make sure about the availability of tax credits. You can also seek the professional guidance of experts like Legal Pillers for timely filing of the TDS Return.
LA HUG - Video Testimonials with Chynna Morgan - June 2024Lital Barkan
Have you ever heard that user-generated content or video testimonials can take your brand to the next level? We will explore how you can effectively use video testimonials to leverage and boost your sales, content strategy, and increase your CRM data.🤯
We will dig deeper into:
1. How to capture video testimonials that convert from your audience 🎥
2. How to leverage your testimonials to boost your sales 💲
3. How you can capture more CRM data to understand your audience better through video testimonials. 📊
[Note: This is a partial preview. To download this presentation, visit:
https://www.oeconsulting.com.sg/training-presentations]
Sustainability has become an increasingly critical topic as the world recognizes the need to protect our planet and its resources for future generations. Sustainability means meeting our current needs without compromising the ability of future generations to meet theirs. It involves long-term planning and consideration of the consequences of our actions. The goal is to create strategies that ensure the long-term viability of People, Planet, and Profit.
Leading companies such as Nike, Toyota, and Siemens are prioritizing sustainable innovation in their business models, setting an example for others to follow. In this Sustainability training presentation, you will learn key concepts, principles, and practices of sustainability applicable across industries. This training aims to create awareness and educate employees, senior executives, consultants, and other key stakeholders, including investors, policymakers, and supply chain partners, on the importance and implementation of sustainability.
LEARNING OBJECTIVES
1. Develop a comprehensive understanding of the fundamental principles and concepts that form the foundation of sustainability within corporate environments.
2. Explore the sustainability implementation model, focusing on effective measures and reporting strategies to track and communicate sustainability efforts.
3. Identify and define best practices and critical success factors essential for achieving sustainability goals within organizations.
CONTENTS
1. Introduction and Key Concepts of Sustainability
2. Principles and Practices of Sustainability
3. Measures and Reporting in Sustainability
4. Sustainability Implementation & Best Practices
To download the complete presentation, visit: https://www.oeconsulting.com.sg/training-presentations
Unveiling the Secrets How Does Generative AI Work.pdfSam H
At its core, generative artificial intelligence relies on the concept of generative models, which serve as engines that churn out entirely new data resembling their training data. It is like a sculptor who has studied so many forms found in nature and then uses this knowledge to create sculptures from his imagination that have never been seen before anywhere else. If taken to cyberspace, gans work almost the same way.
What are the main advantages of using HR recruiter services.pdfHumanResourceDimensi1
HR recruiter services offer top talents to companies according to their specific needs. They handle all recruitment tasks from job posting to onboarding and help companies concentrate on their business growth. With their expertise and years of experience, they streamline the hiring process and save time and resources for the company.
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Memorandum Of Association Constitution of Company.pptseri bangash
www.seribangash.com
A Memorandum of Association (MOA) is a legal document that outlines the fundamental principles and objectives upon which a company operates. It serves as the company's charter or constitution and defines the scope of its activities. Here's a detailed note on the MOA:
Contents of Memorandum of Association:
Name Clause: This clause states the name of the company, which should end with words like "Limited" or "Ltd." for a public limited company and "Private Limited" or "Pvt. Ltd." for a private limited company.
https://seribangash.com/article-of-association-is-legal-doc-of-company/
Registered Office Clause: It specifies the location where the company's registered office is situated. This office is where all official communications and notices are sent.
Objective Clause: This clause delineates the main objectives for which the company is formed. It's important to define these objectives clearly, as the company cannot undertake activities beyond those mentioned in this clause.
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Liability Clause: It outlines the extent of liability of the company's members. In the case of companies limited by shares, the liability of members is limited to the amount unpaid on their shares. For companies limited by guarantee, members' liability is limited to the amount they undertake to contribute if the company is wound up.
https://seribangash.com/promotors-is-person-conceived-formation-company/
Capital Clause: This clause specifies the authorized capital of the company, i.e., the maximum amount of share capital the company is authorized to issue. It also mentions the division of this capital into shares and their respective nominal value.
Association Clause: It simply states that the subscribers wish to form a company and agree to become members of it, in accordance with the terms of the MOA.
Importance of Memorandum of Association:
Legal Requirement: The MOA is a legal requirement for the formation of a company. It must be filed with the Registrar of Companies during the incorporation process.
Constitutional Document: It serves as the company's constitutional document, defining its scope, powers, and limitations.
Protection of Members: It protects the interests of the company's members by clearly defining the objectives and limiting their liability.
External Communication: It provides clarity to external parties, such as investors, creditors, and regulatory authorities, regarding the company's objectives and powers.
https://seribangash.com/difference-public-and-private-company-law/
Binding Authority: The company and its members are bound by the provisions of the MOA. Any action taken beyond its scope may be considered ultra vires (beyond the powers) of the company and therefore void.
Amendment of MOA:
While the MOA lays down the company's fundamental principles, it is not entirely immutable. It can be amended, but only under specific circumstances and in compliance with legal procedures. Amendments typically require shareholder
Personal Brand Statement:
As an Army veteran dedicated to lifelong learning, I bring a disciplined, strategic mindset to my pursuits. I am constantly expanding my knowledge to innovate and lead effectively. My journey is driven by a commitment to excellence, and to make a meaningful impact in the world.
3.0 Project 2_ Developing My Brand Identity Kit.pptxtanyjahb
A personal brand exploration presentation summarizes an individual's unique qualities and goals, covering strengths, values, passions, and target audience. It helps individuals understand what makes them stand out, their desired image, and how they aim to achieve it.
Digital Transformation and IT Strategy Toolkit and TemplatesAurelien Domont, MBA
This Digital Transformation and IT Strategy Toolkit was created by ex-McKinsey, Deloitte and BCG Management Consultants, after more than 5,000 hours of work. It is considered the world's best & most comprehensive Digital Transformation and IT Strategy Toolkit. It includes all the Frameworks, Best Practices & Templates required to successfully undertake the Digital Transformation of your organization and define a robust IT Strategy.
Editable Toolkit to help you reuse our content: 700 Powerpoint slides | 35 Excel sheets | 84 minutes of Video training
This PowerPoint presentation is only a small preview of our Toolkits. For more details, visit www.domontconsulting.com
Affordable Stationery Printing Services in Jaipur | Navpack n PrintNavpack & Print
Looking for professional printing services in Jaipur? Navpack n Print offers high-quality and affordable stationery printing for all your business needs. Stand out with custom stationery designs and fast turnaround times. Contact us today for a quote!
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
www.intertek.com
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
www.intertek.com
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
www.intertek.com
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
www.intertek.com
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
www.intertek.com
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
www.intertek.com
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
www.intertek.com
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.
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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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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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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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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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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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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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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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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.
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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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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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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
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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)
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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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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.
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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.
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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
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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
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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
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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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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
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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
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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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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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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
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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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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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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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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.
80
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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