Comparative Study of Medical Devices Regulations in India, Us, and Europe by

COMPARATIVE STUDY OF MEDICAL DEVICES
REGULATIONS IN INDIA, US, AND EUROPE

by
Aleena Joshy (18p0456)
Anusha.S (18p0458)
Harshashree .M (18p0474)
Kavya S.M (18p0482)
Project work Submitted to the
Rajiv Gandhi University of Health Sciences, Karnataka, Bengaluru
In partial fulfillment
of the requirements for the degree of
Bachelor of Pharmacy
in
Pharmaceutical Regulatory Science
Under the guidance of

Dr. Eswar Gupta Maddi
Department of Pharmaceutics
Krupanidhi College of Pharmacy

Bangalore
2021-2022
EVALUATION CERTIFICATE
This is to certify that the project entitled “COMPARATIVE STUDY OF MEDICAL DEVICES
REGULATIONS IN INDIA, US, AND EUROPE” is carried out by Aleena Joshy, Anusha.S,
Harshashree M and Kavya S.M in partial fulfilment of the requirement for the Degree of Bachelor
of Pharmacy .This is to certify that this project has been evaluated
Internal Examiner External Examiner
Signature
Name
College
Date
DECLARATION BY THE CANDIDATE
We hereby declare that this Project work entitled “COMPARATIVE STUDY OF
MEDICAL DEVICE REGULATIONS IN INDIA, US AND EUROPE” is a bonafide and
genuine research work carried out by us under the guidance of
Dr. Eswar Gupta Maddi, Professor, Krupanidhi College of Pharmacy, Bangalore.
Date:
Aleena Joshy
Place:
Anusha S
Harshashree M
Kavya S M
CERTIFICATE BY THE GUIDE
This is to certify that the project work entitled “COMPARATIVE STUDY OF MEDICAL
DEVICE REGULATIONS IN INDIA, US AND EUROPE” is a bonafide research work
done by Aleena Joshy, Anusha S, Harshashree M and Kavya S M in partial fulfilment of the
requirement for the degree of Bachelor of Pharmacy.
Date: Signature of the Supervisor

Place: Dr. Eswar Gupta Maddi
ENDORSEMENT BY THE HOD, PRINCIPAL / HEAD OF THE
INSTITUTION
This is to certify that the project work entitled “COMPARATIVE STUDY OF MEDICAL
DEVICE REGULATIONS IN INDIA, US AND EUROPE” is a bonafide research work
done by Aleena Joshy, Anusha S, Harshashree M and Kavya S M under the guidance of
Dr. Eswar Gupta, Professor, Krupanidhi College of Pharmacy, Bangalore.
Seal & Signature of the HOD Seal & Signature of the
Principal
Name: Name:
Date: Date:
COPY RIGHT
Declaration by the Candidate
We (Aleena Joshy, Anusha S, Harshashree M and Kavya S M of Krupanidhi College of
Pharmacy, Bangalore) hereby declare that the Rajiv Gandhi University of Health Sciences,
Karnataka shall have the perpetual rights to preserve, use and disseminate this project work in
print or electronic format for academic/ research purpose.
Date: Signature of the Candidates
Place: Aleena Joshy
Anusha S
Harshashree M
Kavya S M
© Rajiv Gandhi University of Health Sciences, Karnataka

ACKNOWLEDGMENT
This thesis is a result of six months of hard work, during which several people have played a
crucial role in its completion. It is great pleasure that now I have the opportunity to express
my gratitude to all of them.
Above all I thank the almighty for having given me, courage to undertake it as my project, the
patience for completing it and for a guide, so supportive, without whom this gigantic task
could never have been fulfilled.
We take this opportunity to express my heartfelt gratitude and indebtedness to my respected
guide Dr. Eswar Gupta, Professor, Department of Pharmaceutics, Krupanidhi College of
Pharmacy, Bengaluru, who constantly motivated, supported, encouraged and guided us. His
invaluable guidance and continuous help in every aspect enabled us to complete our thesis
and without his cooperation we would not have presented this project successfully.
We would like to express our deep sense of gratitude to Dr. Raman Dang, Principal,
Krupanidhi College of Pharmacy, for providing all facilities and opportunities during the
B.Pharm academic programme.
We further avail this opportunity to thank all faculty members of Department of
Pharmaceutical Sciences for their immense guidance and help during our B.Pharm course.
Lastly, we would like to thank my parents, my family and all my friends for their
unconditional love, support and care.
Date: Signature of the Candidates
Place: Aleena Joshy

Anusha S
Harshashree M
Kavya S M
Aleena Joshy
LIST OF ABBREVIATIONS USED
Sl.No Abbreviations Full Form
1 CDSCO Central drug standard control organization
2 DCGI Drug controller general of India
3 BMR Batch manufacturing record
4 D&C ACT Drug and cosmetic act
5 CLAA Central licensing approval authority
6 MDAC Medical device advisory committee
7 ISO International organization of standardization
8 MDR 2017 Medical device rules 2017
9 SOP Standard operating procedure
10 CLA Central licensing authority
11 USFDA United states of food and drug administration
12 QSR Quality system regulation
13 GMP Good manufacturing practices

14 QMS Quality management system
15 IDE Investigational device exemption
16 CFR Code of federal regulation
17 PMA Premarket approval
18 PMN Premarket notification
19 CDRH Center for devices and radiological health
20 AIMDD Active implantable medical device
21 EEC European economic commitee
22 CE Conformite europeenne
23 EU European union
24 NB Notified body
25 EAR European authorized representative
26 CER Clinical evaluation report
27 MDR Medicinal device regulation
28 EMA European medical agency
29 STED Summary of technical documentation
30 DOC Declaration of conformity
31 SMF Site master file
32 NB-MD Notified body medical device
33 IVDMDD In-vitro diagnostic medical device directive

LIST OF TABLES
Sl. No. Tables Page No.
1 Countries and their regulatory agencies 3
across the world
2 Classification of medical devices 6
3 Classification of medical devices in united states 13
4 Classification of medical device in EU 20
5 Classification of Medical device in INDIA 26
6 Comparison of approval process in USA,EU, 32
CDSCO
LIST OF FIGURES
Sl.No. Figures Page
No.
1 Classification of medical device with examples in USFDA 14
2 Regulatory approval pathway in USA 19
3 CE MARK 23
Table of Contents
Sl. No Content Page
Number
1 Introduction 1
2 Objectives 7
3 Review of literature 8
4 Methodology 13
5 Results and discussion 32
6 Summary and conclusion 34
7 References 35
Abstract
Any medical equipment must get a marketing authorisation from a regulatory authority
before it can be sold. Obtaining authorization is a lengthy, multi-step process that requires
relevant authorities to review material. After analysing the information given by the
Manufacturer, the concerned Regulatory authority provides marketing authorization.
Safety and efficacy of a medical device for use in humans is essential before the product can
be approved for import or manufacturing and sale. For this, every country has its regulatory
authority that bears the responsibility of evaluating whether the research data of new medical
product supports the safety and efficacy to serve public health. The manufacturers in
different countries need to follow different regulatory requirements for approval of new
medical devices.
Manufacturers in the United States must apply to the US Food and Drug Administration for
Marketing Authorization (USFDA).
The marketing of medical devices is permitted by national authorities in the EU.
The sale and import of medical devices are approved by India’s Central Drugs Standard
Control Organization (CDSCO).
Our objective is to study and compare the various regulatory approval process and to find
out the best one.

INTRODUCTION
1.INTRODUCTION - DRUG REGULATORY AFFAIRS
1.0: Regulatory affairs: It is also called as government affairs and is the interface between
pharmaceutical company and regulatory agencies across the world.
Regulatory affair is a mixture of science and management and it aims to attain commercially
essential objective in drug development organization. It is a profession developed to protect
public health by controlling safety and efficacy of products in areas including
pharmaceuticals, veterinary medicines, medical devices, food, pesticides, cosmetics and
complementary medicines.
1.0.1: FUNCTIONS OF REGULATORY AUTHORITIES:
1. Keep in touch with international legislations, guidelines and customer practices.
2. Formulate regulatory strategy for all appropriate regulatory submission for international
and contract projects.
3. Prepare and review of SOPs, BMR, MFR, change control and other relevant documents.
4. Guaranteeing the safety, efficacy and quality of drugs.
5. Scientific advice to stimulate the development and improve the availability of
innovative new medicines.
1.0.2: ROLE OF REGULATORY AFFAIRS IN PHARMACEUTICAL INDUSTRY:
1. The regulatory affairs department of a pharmaceutical company is responsible for
obtaining approval for new pharmaceutical products and ensuring that approval is
maintained for as long as the company wants to keep the product in the market.
2. It serves as a connecting bridge between regulatory authority and the project team.
KRUPANIDHI COLLEGE OF PHARMACY 1|Page

INTRODUCTION
3. It acts as channel of communication with regulatory authority as project proceeds,
aiming to ensure that the project plan anticipates what the regulatory authority will require
before approving the product.
4. Regulatory affairs professional play a key role in advising on the realistic prescribing
information (label) for intended product.
5. RA department reviews all documentation ensuring that it is clear, consistent and
complete and its conclusions are explicit. The documentation includes clinical trial
applications, regulatory submission for new products and for changes to approved products.
6. An important proactive task of RA is to provide input when legislative changes are
being proposed and discussed.
7. The regulatory affairs liaisons with regulatory health agencies like FDA, ICH for
registration and technical requirement of pharmaceutical for human use.
8. RA typically consists of group of scientists who formulate the strategy for interacting
with regulatory authorities of various countries as well as the tactics of securing responses
to the questions dealing with submissions and maintaining communication post registration.

INTRODUCTION
1.1: REGULATORY SYSTEMS ACROSS THE WORLD:

Table 1.1: Countries and their regulatory agencies across the world
COUNTRY NAME OF REGULATORY AUTHORITY
USA Food and Drug Administration (FDA)
UK Medicines and Healthcare Products Regulatory Agency (MHRA)
Australia Therapeutic Goods Administration (TGA)
India Central Drug Standard Control Organization (CDSCO)
Canada Health Canada
Europe European Medicine Agency (EMA)
Denmark Danish Medicines Agency
Netherlands Medicines Evaluation Board
Italy Italian Pharmaceutical Agents
China State Food and Drug Administration
Japan Pharmaceuticals and Medical Devices Agency (PMDA)

INTRODUCTION
1.2: Medical devices:
The advent of 1950s and 1960s saw tremendous technological advances thereby giving a
fillip to innovation in the field of Pharmaceutical and Medical Device Industry. Today these
Industries are estimated to worth billions of dollars. Medical Devices have enhanced the
quality of healthcare at our disposal by making diagnosis, prevention and treatment of
diseases and serious health conditions, easier and efficient. It is worth mentioning that
development of Medical Devices, in relation to, Pharmaceuticals is less expensive and time
consuming. The GMP requirements are by far less stringent than Pharmaceuticals.[10]
However, with passage of time, enhanced technology has become increasingly complicated
and intricate, so much so, that it has several times circumvented the understanding of
Medical Professionals, Device developers and Regulators. These parties often encounter
problems in understanding deficiencies and gaps in the development process consequently
resulting in Patient injuries, adverse events (serious or non-serious) and even deaths, and
leaving room for Public Hazard. Thus it is clear that there is a need for effective regulation
to be put on devices being circulated in the International and National commerce. [10]
The Regulations of Medical Devices is vast and rapidly evolving field that is often
complicated by legal and technical issues, for instance information on patent status, market
approvals in other regions as a legal requirement, safety and efficacy data, engineering
aspects etc. for technical requirements. [10]
The medical device industry in India is growing rapidly, at a rate of 15.8% over the past five
years.[11] This compares favorably with the global medical device industry, which is growing
at a rate of 4.1%. Medical technology is increasingly important in the modern world. The

INTRODUCTION
prevalence of diseases treated with medical devices has increased significantly in recent
years.[12]
The Regulations of Medical Devices is sizeable and quickly developing discipline. Different
Regulatory Authorities under remote regulatory assessment (RRA) is a voluntary program
for medical device facilities under FDA have given us strategies every now and then.
Obtaining authorization can be a lengthy and complex process, requiring the assessment of
material by relevant authorities. [11]
After evaluating the information provided by the Manufacturer, the concerned Regulatory
authority grants marketing authorization. Obtaining authorization is a lengthy, multi-step
process that necessitates the assessment of material by relevant authorities.[11]
The concerned Regulatory authority grants marketing authorization after evaluating the
information provided by the Manufacturer. Routine medical treatments such as bandaging a
sprained joint, diagnosing numerous diseases, or implanting a prosthetic hip would be
impossible without medical gadgets.[11]
Various Regional Regulatory Authorities (RRAs) have come up with regulations from time
to time.[9]
The USFDA put regulations in place in 1976, through Medical Device Amendment in the
Food, Drugs and Cosmetic Act of 1938.
The European Commission, of EU regulates Medical Devices through Medical Device
Directive, 93/42/EEC of 1993. The Member states follow the directives of EU with
modifications as per pertinent rules and obligations.

INTRODUCTION
The CDSCO, Government of India, regulates a handful of devices under Central License
Approval Authority scheme (CLAA), called Notified Devices. Government of India is
mulling changes to extant regulatory apparatus.[9]
A medical device is a non‐biochemical object used for medical purposes in human patients,
for diagnostic, therapeutic, supporting, replacing, prevention or any similar physical effect
giving application.[21]
Table 2: Classification of medical devices
USA EUROPE INDIA
Class I Class I Class A
Class II Class IIa Class B
Class III Class IIb Class C
Class III Class D

OBJECTIVES
2.Objectives
Safety and efficacy of a medical device for use in humans is essential before the product can
be approved for import or manufacturing and sale. For this, every country has its regulatory
authority that bears the responsibility of evaluating whether the research data of new medical
product supports the safety and efficacy to serve public health. The manufacturers in
different countries need to follow different regulatory requirements for approval of new
medical devices. Our objective is to study and compare the various regulatory approval
process and to find out the best one.
PLAN OF WORK
1. Literature review
2. Study of approval process in USA.
3. Study of approval process in Europe.
4. Study of approval process in India.
5. Comparative study on approval process In India, US, and European union (EU) and
concluding the best one.

REVIEW OF LITERATURE
3.Review of Literature
Travis G Maak and et.al., compared the regulations of medical devices in Europe and USA.
They concluded that the approval process is different in USA and Europe. The FDA approval
process mandates that a device be proved efficacious compared with a control or be
substantially equivalent to a predicate device, whereas the European Union approval process
mandates that the device perform its intended function. After recent high-profile device
failures, political pressure in both the United States and the European Union has favored more
restrictive approval processes. Substantial reforms of the European Union process within the
next 5 to 10 years will result in a more stringent approach to device regulation, similar to that
of the FDA. Changes in the FDA regulatory process have been suggested but are not
imminent.[1]
Mattias Kyhlstedt discussed the need for action by evaluators and decision makers in Europe
to ensure safe use of medical software. He found that Digital Health Solutions (DHS) approved
under the Medical Device Directive (MDD) in the European Union may be used until May 27,
2025. The regulation provides appropriate requirements for the products but lack the evaluation
by an external independent organization. For many DHS, the company can make a self-
certification that the requirements have been fullfilled. As demonstrated in the evaluation of
smartphone-based apps for skin cancer risk assessment such products may expose the public to
undue risks. The new Medical Device Regulation provides adequate control of DHS through
evaluation of independent organization prior to allowing the product on the market. HTA-
evaluators and those who make decisions regarding the use of DHS need to understand the
associated risks with the use of products approved according to the MDD and ensure
appropriate risk mitigations to ensure that the public is not exposed to undue risk. This

perspective aims to inform decision makers about the risks associated with the delayed
requirement to transition to the new MDR regulation. There is a gap in the current guidance
regarding the evolving use of machine learning and artificial intelligence. With the evolving
use of DHS, it is important that industry, regulators and HTA evaluators work jointly to
establish the safe and effective use of DHS. [2]
Manas Manu and Gaurav Anand carried a review of medical device regulations in India,
comparison with European Union and way-ahead. They concluded that Indian healthcare sector
is a fast-growing industry which is expected to reach $280 billion by 2025. Medical devices
market in India is one of the top 20 medical device markets in the world. It is currently valued
at $5.2 billion and is expected to reach $50 billion by 2025. However, India does not
manufacture many devices indigenously and still imports approximately 70% of its medical
devices. Manufacturing and monitoring of medical devices are highly regulated activities. In
India, there were no specific medical device regulations and devices were regulated under the
Drugs and Cosmetics Act, 1940. To fulfill this gap, Central Drug Standard Control
Organization released Indian Medical Device Rules, 2017, which are the new regulations for
medical devices in India. Keeping pace with the requirements, these were amended as Medical
Devices (Amendment) Rules, 2020, which has come into force in April 2020. These rules cover
various aspects of device related regulations, including classification, registration,
manufacturing and import, labeling, sales, and postmarket requirements, etc. The rules are a
positive step and encompass most of the European Union (EU) approval process, which
mandates that the devices are safe and performs its intended function. However, with rapid
advancements in medical device technology, much is desired in clarity and revamping of the
current regulatory system to harmonize standards to be in-line with advanced regulations like
EU. [3]

Chandhan B. V. and et.al., compared Medical Device Regulations in India, Japan and South
Korea. They concluded as follows. Increased health awareness, a growing middle class, and
government health efforts are projected to propel India’s medical equipment market forward in
the next years. With the publication of the Medical Device Rules in 2017, Indian authorities
revised the medical device regulatory process. The devices included in the link are currently
regulated medical devices and in vitro diagnostic devices, as well as their classifications. CLA
(Central Licensing Authority) is in charge of all import device licencing, as well as
manufacturing, loan, and wholesale license’s for Class C and Class D medical devices.[4]
Because of its complicated registration process and linguistic obstacles, Japan is regarded one
of the most difficult markets for overseas medical device producers. The Pharmaceutical and
Medical Device Agency, which works in tandem with the MHLW (Ministry of Health and
Labour Welfare), is in charge of reviewing drug and medical device applications in Japan. The
Pharmaceuticals and Medical Devices Act is a federal law that regulates the sale of
pharmaceuticals and medical devices. The Pharmaceuticals and Medical Devices Act, also
known as the Act on Securing Quality, Efficacy, and Safety of Pharmaceuticals, Medical
Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics,
lays out the current PMDA (Pharmaceuticals and Medical devices Agency) laws in Japan.
South Korea is one of the largest health-care markets in the Asia-Pacific region. Medical
Devices in South Korea are regulated by the Ministry of Food and Drug Safety (MFDS),
formerly known as the Korea Food and Drug Administration (KFDA). Medical Devices in
South Korea are regulated by the Ministry of Food and Drug Safety, formerly known as the
Korea Food and Drug Administration. The Medical Device Act of 2015 governs current
medical device laws in Korea. To access the South Korean Medical-Device-Market, you must
first obtain marketing approval from the local Medical Device Authority, the Medical Device
Information & Technology Centre, which is part of the Ministry of Food and Drug Safety. With
KRUPANIDHI COLLEGE OF PHARMACY 10 | P a g e

the MFDS notification No. 2020-29, the South Korean Ministry of Food and Drug Safety
launched UDI (Unique Device Identification System) operations in 2018. Article 20 of the
Medical Device Act and Article 54-2 of the Medical Device Act Enforcement Regulations
make UDI compliance mandatory. [4]
Vivek Dave and et.al., have done a review on CURRENT SCENARIO OF REGULATION
AND MONITORING OF MEDICAL DEVICES IN GLOBAL REALMS OF WORLD. They
concluded as follows. The article focuses monitoring of medical devices throughout the globe
the current scenario of regulation and approval of the devices which involve different countries
having their respective regulatory bodies, which look after different sets of procedure for their
[5]
regulation of devices, which are classified in distinct classes on the basis of level of risk.
Priyadarshini B and et.al., done a comparative Study of Medical Devices in USA, Europe and
India and concluded as follows. Any medical equipment must get a marketing authorisation
from a regulatory authority before it can be sold. Obtaining authorization is a lengthy, multi-
step process that requires relevant authorities to review material. After analyzing the
information given by the Manufacturer, the concerned Regulatory authority provides marketing
authorization. Manufacturers in the United States must apply to the US Food and Drug
Administration for Marketing Authorization (USFDA). There are two types of applications in
the United States: 510(k) and Pre-Market Application (PMA). The marketing of medical
devices is permitted by national authorities in the EU. Notified Bodies (Third Parties) ensure
Quality Assurance both before and after approval via third-party compliance. The sale and
import of medical devices are approved by India’s Central Drugs Standard Control
Organization (CDSCO). The CLAA scheme regulates medical devices. The central licensing
authority for medical devices in India is the Drug Controller General of India (DCGI). This
study aims to collect information on medical device regulations in three regions: the United

States, the European Union, and India, and compare market authorization provisions in each
region, as well as make this complex subject easier to understand for the readers. The medical
device sector is made up of several different sorts of items that are used for a variety of
purposes. Medical devices must be governed by tight rules according to the different risk
categories since their safety and effectiveness are critical to human health. A common
framework for medical device regulations is a comprehensive product life cycle regulatory
system that includes product design, manufacture, premarket gatekeeping, and post market
monitoring. Medical gadgets, on the other hand, are diverse and inventive, putting current
regulatory systems to the test. As a result, competent authorities in charge of medical devices
around the world are constantly updating their regulatory systems to ensure that medical
devices are safe and effective. The goal of this study is to provide an overview of the regulatory
regimes for medical devices in the United States. [9]

METHODOLOGY
4.Methodology
4.1 USFDA
USFDA defines medical device as “A medical device is an instrument, apparatus,
implement, machine, contrivance, implant, in vitro reagent, or other similar or related
article, including a component part, or accessory which is:
 recognized in the official National Formulary, or the United States Pharmacopoeia, or
any supplement to them.
 intended for use in the diagnosis of disease or other conditions, or in the cure,
mitigation, treatment, or prevention of disease, in man or other animals,
or
 intended to affect the structure or any function of the body of man or other animals, and
which does not achieve any of its primary intended purposes through chemical action within
or on the body of man or other animals and which is not dependent upon being metabolized
for the achievement of any of its primary intended purposes’.[23]
4.1.1 Medical device classification in united states:
Table 3 classification of medical devices in united states
CLASS I: low risk of illness or injury,

Ex: gauze, toothbrushes
CLASS II: moderate risk of illness or injury,

Ex: suture, needles
CLASS III: significant risk of illness or injury

Ex: pacemakers, implantable defibrillators

METHODOLOGY
Figure 1 classification of medical device with example
4.1.2 Procedure of Marketing Authorization in the United States of
America
In the United States of America, Medical Devices are regulated by Food and Drug
Administration (FDA). FDA's Centre for Devices and Radiological Health (CDRH) is
responsible for regulating firms who manufacture, repackage, re-label, and/or import
medical devices sold in the United States.
A system of Device classification is followed in the US. Devices are classified into Class I,
II or III. Each device is assigned to a panel (Cardiovascular, Anaesthesiology etc.). The
panel determines the Class and special controls and exemptions applicable to the device.[10]
 General Controls include:
• Establishment Registration by manufacturers, distributors, repackages and re-labellers,
• Medical Device Listing with FDA of devices to be marketed,

METHODOLOGY
• Manufacturing the devices in accordance with Good Manufacturing Practices,
• Labelling medical devices in accordance with the labelling regulations, 21 CFR 801 or 21
CFR 809,
• Medical Device Reporting of adverse events as identified by the user, manufacturer and/or
distributor of the medical device.
 Special Controls may include:
• Adherence to performance standards, guidance documents,
• Implementation of post-marketing surveillance measures,
• Special labelling.[10]
4.1.3 REGULATORY PATHWAY
The FDA has established classifications for approximately 1,700 different generic types of
devices and grouped them into 16 medical specialties referred to as panels. Each of these
generic types of devices is assigned to one of three regulatory classes based on the level of
control necessary to assure the safety and effectiveness of the device. The Devices are placed
in Class I, II or III. All the classified devices are available on the website of FDA.
Class I devices are defined as non-life sustaining and present minimal harm potential to user.
These devices are typically simple in design, manufacture and have a history of safe use.
Their failure poses no risk to life and hence are subject to general control and require least
regulations, these devices have to comply with Quality System Regulations (QSR) laid in
21 CFR Part 820 and labelled according to 21 CFR Part 821. Although most are exempt
from 510 (k) pathway and some are even exempt from QSR. For example tongue depressors
are exempt from 510 (k) but stethoscopes are not.
Class II medical devices are devices where General Controls are not sufficient to assure
safety and effectiveness and existing methods/ standards/guidance documents are available
to provide assurances of safety and effectiveness. In addition to compliance with General

METHODOLOGY
Controls, Class II devices are required to comply with Special Controls. Special Controls
may include:
• Special labelling requirements,
• Mandatory performance standards, both International and United States,
• Post-marketing surveillance,
• FDA medical device specific guidance.
Information on Class II exempt devices is located within the device regulation, 21 CFR 862
through 892. Devices falling in these class are cleared for sale only through 510 (k)
regulatory pathway, where the applicant demonstrates that the ‘Device’ is substantially
equivalent to an existing device called, ‘Predicate device’ and Clinical Trials may be
required for devices falling in this class.
The information required in a 510 (k) submission is defined 21 CFR 807.87.
Class III devices usually support or sustain human life, are of substantial importance in
preventing impairment of human health, or present a potential unreasonable risk of illness
or injury to the patient. Devices falling in this class have to demonstrate safety and efficacy
through Clinical Trials.
For Class III medical devices, sufficient information is not available to assure safety and
effectiveness through the application of General Controls and Special Controls. Typically a
Pre-Market Approval (PMA) submission to the FDA is required to allow marketing of a
Class III medical device. Section 515 (c) (1) of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) specifies the required contents of a PMA.
Some devices falling in Class III includes replacement heart valves, PTCA balloons,
implanted cerebella stimulators, Pacemaker. These devices mandatorily require Phase IV
trials data. A few Class III medical devices are required to only have a 510 (k) cleared by
the FDA to be marketed.

METHODOLOGY
Manufacturers are required to submit their application for review. Depending on the
complexity of the new or modified medical device, the FDA Review of a 510 (k) submission
takes between 20 and 90+ days. The more complex the changes or comparison required to
support the safety and effectiveness of the new or modified medical device, the longer the
FDA review process.
The FDA has a statutory 180-day review cycle for PMA applications. Often PMA
applications require medical advisory board review prior to the FDA granting approval to
market the medical device. A facility inspection verifying the manufacturing systems present
to manufacture the medical device is usually performed prior to FDA PMA approval. FDA
approval of a PMA often requires significantly more than 180 days. [17]
The FDA reviews the application (510 (k) or PMA) and if satisfied with, data posts online a
510 (k) clearance letter or PMA Approval Letter. Following which a device could be
marketed in the USA. Any changes to constitution of device shall be informed to FDA
through supplement filing as per the prescribed timelines.[10]
 Steps for marketing approval in USA
The US FDA medical device approval process
 Step 1
Determine the classification of your device according to standard FDA classification.
 Step 2
Class I devices have to comply with the QSR (GMPs), expect for part 820.
Class II and class III devices, implement Quality Management System (QMS) which meets
the FDA Quality system regulation (QSR) found in 21 CFR part 820.
 Step 3
Innovative class II, class III, devices will likely require clinical studies.
Get ‘pre –submission (pre-sub)’ feedback from the FDA.

METHODOLOGY
 Step 4
If clinical studies will required, apply for an investigational device exemption (IDE).
Develop clinical trial protocol and conduct studies.
Non-significant risk studies may be performed with IRB approval.
 Step 5
For class II devices, prepare and submit 510(k) premarket notification application and pay
related fee.
For class III devices, prepare and submit Premarket Approval (PMA) Application. Pay PMA
submission fee.
 Step 6
For class III devices, FDA conducts facility inspections of all major suppliers involved in
the design and production of your device.
All the parties must be complaint with QSR.
 Step 7
For class II devices, the FDA issues 510(k) clearance letter and posts it online.
For class III devices, the FDA issues PMA approval letter and posts it online.
 Step 8
If you have no local presence in the US, appoint an FDA US Agent representative as a local
point of contact with the FDA.
 Step 9
List the device on the FDA website in accordance with the 21CFR part 807.
Pay fees for Establishment registration and listing which must be renewed each year.
 Step 10
Manufacturer is now able to sell the device in the US. Device registration status will be listed
on the FDA website.

METHODOLOGY
Authorization does not expire as long as no changes are made to the device design, intended
use etc.[10]
Figure 2 Regulatory approval pathway in USA

METHODOLOGY
4.2 EUROPEAN UNION
European union defines medical device as “any instrument, apparatus, appliance, software,
material or other article, weather used alone or in combination, including the software
intended by its manufacturer to be used specifically or diagnostic and/or therapeutic purposes
and necessary for its proper application, intended by the manufacturer to be used for human
beings.”[22]
4.2.1 Medical device classification in European union:
Table 4 classification of Medical device in EU
CLASS I: low risk;
Ex: sterile dressings, gloves
CLASS II a: low-medium risk;
Ex: surgical blades, suction equipment
CLASS II b: medium to high risk;
Ex: ventilators, some implants, radiotherapy equipment
CLASS III: high risk;
Ex: drug-eluting cardiac stents, pacemakers, implantable
defibrillators
4.2.2 Procedure of Marketing Authorization in European Union
In EU, there is decentralized procedure of marketing authorization as no single body
regulates Medical devices. A system of third party compliance is followed. Notified Bodies

METHODOLOGY
are the third party that issue Quality Assurance certificates and ensures post approval
compliance to Quality Management System (QMS).
Medical Devices are regulated by Medical Devices Directive, which consists of three
directives that regulate the safety and marketing of medical devices in Europe. The three
directives are:
• Medical Device Directive (MDD 93/42/EEC),
• Active Implantable Medical Device Directive (AIMDD 90/42/EE),
• In vitro Diagnostic Medical Device Directive (IVDMDD 98/79/ EC).
These directives are regularly updated. The directive 93/42/EEC has been thus far
amended five times.
The last amendment was 2007/47/EC, which came into effect in march 2010.[20]
4.2.3 CE CERTIFICATION
CE mark: European Conformity is a conformity mark that all the devices
must bear before they can be placed in the market in Europe from 1985, helps in
worldwide recognition.
 Key players in the CE marking process:
 Manufacturers and subcontractors
 Competent authorities
 Notified bodies
 Authorized representatives
 Distributors

METHODOLOGY
Medical Devices cannot be placed on European Market without conforming to the
Strict safety requirements of EU. A device must bear CE mark, except for
Custom-made devices; Devices for clinical investigation, health protection-urgent
unusual circumstances; humanitarian use and In-house use.
The Notified Body is effectively responsible for pre-market evaluation of medical
devices. They monitor all aspects of the evaluation from manufacturing process to
post-market surveillance.
Devices are labelled as per Annex I of Council Directive 93/42/EEC in national
language and use of appropriate symbols is recommended. Conformity assessment of
the Device is performed by a Notified Body.
Technical Documentation should be submitted to the NB for assessment. Documents
Are accepted in IMDRF format (STED) or as per Notified Bodies Medical Devices
NB-MED) recommend document (NB-MED/2.5.1/Rec 5) 'Technical documentation'.
STED and NB-MED format include comprehensive information on device
They review all data (including clinical data), conduct regular inspections (including
impromptu on-site inspections) and collect reports regarding safety. Adverse event
reporting to the Competent Authority is mandatory for the manufacturer. Once
a device is reviewed and deemed acceptable, it receives the CE marking [8]. Once NB
clears a device, manufacturer can declare conformity and place the device in market.
An NB can conduct surprise audit to ensure conformance to QMS by the

METHODOLOGY
Manufacturer. Documents must be kept at disposal of Competent Authority for five
years (fifteen Years for implantable Devices).
The timelines for gaining approval differs for different class of devices, complexity of design
and risk to the user with use of device. After being approved for marketing class I devices’
validity is indefinite and for Class II and III devices validity is for 3 years.
Any change in the constitution of device, thereafter has to be informed to the Notified Body
as per prescribed timelines.[10]
Figure 3 CE MARK
4.2.4 Regulatory process for medical devices in EU
 Step 1
Determine which EU medical device directive applies to the device for certification;
93/42/EEC- Medical Devices Directive (MDD) or
90/385/EEC-Active Implantable Medical Devices Directive (AIMDD)
 Step 2
Determine classification of device using Annex IX of the Medical Devices Directive
(MDD); class I (non-sterile, non-measuring),
class I (sterile measuring), class II a, class II b or class III/AIMD.
Active implantable medical devices are typically subject to the same regulatory
requirements as class III devices.

METHODOLOGY
 Step 3
For all devices expect class I, implement Quality Management System (QMS) in accordance
with Annex II or V of the MDD.
For class I, a QMS is not formally required, though not likely to be audited by a Notified
Body (NB).
 Step 4
For classes I through II b, prepare a technical file which provides detailed information on
medical device, and demonstrates compliance with 93/42/EEC.
For class III/AIMD devices, prepare a design dossier.
 Step 5
Appoint an European Authorized Representative (EAR rep) located in Europe.
The EAR rep should be qualified to handle regulatory issues.
 Step 6
For all device except Class I,
QMS and technical file must be audited by Notified Body
 Step 7
For all devices expect class I, manufacturer will be issued a European CE Marking
Certificate for device and an ISO 13485 certificate for facility following successful
completion of Notified Body audit.
 Step 8
Prepare a declaration of conformity, a legally binding document prepared by the
manufacturer stating that the device is in compliance with the applicable directive.
 Step 9
All class I devices must be registered with the competent authority.
 Step 10

METHODOLOGY
 For class I,
 CE Certificates do not expire.
 Must perform and PMS activities.
For all other classes, manufacturer will be audited each year by a Notified Body to ensure
on-going compliance with 93/42/EEC or 90/385/EEC.
Failure to pass the audit will invalidate your CE marketing certificate. CER must perform
updates and PMS activities.[22]

METHODOLOGY
4.3 INDIA
INDIA by drugs and cosmetic act 1940 and rules 1945 defines medical devices “intended
for internal or external use in the diagnosis, treatment, mitigation or prevention of disease
or disorder in human beings or animals, as may be specified from time to time.”[21]
4.3.1 Classification:
Medical device classification in India:
The draft schedule M-III, released by the central drug standards control organization
(CDSCO) of India, includes a proposed risk classification for medical devices, based on
their intended use.
Table 5 classification of Medical device in India
Class Risk level Device examples
A Low risk Thermometers/ tongue
depressors
B low- moderate risk Hypodermic needles/
suction equipment
C Moderate-high risk Lung ventilator/ bone
fixation plate
D High risk Heart valves/ implantable
defibrillator

METHODOLOGY
4.3.2 Procedure of Marketing Authorization in India
The Government of India regulates medical devices through a specialized division
called, Medical Device and Diagnostics Division, CDSCO, Ministry of Health and
Family Welfare.
Only a few Medical Devices and Diagnostic kits, called Notified
Devices, are regulated under Central Licensing Approval Authority (CLAA) scheme
for the purpose of Manufacture, Import, Sale and Distribution. Drug Controller General
of India (DCGI) is the Central Licensing Authority. The regulation of Notified Medical
Devices is overseen by both, the central government and the state governments. Under
the applicable regulatory framework, the functions of manufacture, import, distribution
and sale of medical devices require licenses or permissions, as the case may be. Import,
manufacture, sale and distribution of Medical devices are regulated under Drugs and
Cosmetics Act, 1940; and Rules, 1945. At present following notified Medical Devices
are regulated under the Act. Further the following products are regulated as
“Drugs” under Drugs and Cosmetics Act and Rules there under which are considered
‘Medical Device’ in the Country of Origin. This provision is ambiguous and
inconsistent with Harmonized Standards of Medical Devices. Manufacture for sale of
these products is regulated by the concerned State Drug Licensing Authority only. [18]

METHODOLOGY
 Items classified as drugs in India
• Blood Grouping Sera.
• Ligatures, Sutures, Staples.
• Intra Uterine Devices (Cu-T).
• Condoms.
• Tubal Rings.
• Surgical Dressing.
• Umbilical Tapes.
• Blood Component Bags, Blood Bags.
CDSCO/MD/GD/CLAA/01/00: Guidance Document on application for grant of
License in Form-28 for Manufacture of Medical Devices in India under CLAA scheme.
 List of items for Grant of License in Form-28 for Manufacture of Medical Devices in
India as outlined in CDSCO/MD/GD/CLAA/01/00
• Covering Letter,
• Authorization Letter,
• A duly filled Form-27,
• Requisite Fee (License fee Rs. 6000/- and Inspection fee Rs. 1500/-),
• Constitution Details of firm
• Approved Manufacturing Premises Plan/Layout,
• Full Details of competent and regular technical staff

METHODOLOGY
• Site Master File (SMF),
• Specific Environmental Requirements,
• Device Master File,
• Details of Standards,
• Promotional literature, package insert, device label etc.
• ISO 13485:2003 Certificate (if any), CE mark (if any), any other approval (if any).
CDSCO/MD/GD/IL/01/00: Guidance Document on Common Submission format for
Import License in Form 10 of Notified Medical Devices in India.
 List of items for Common Submission Format for Import License in Form 10 of
Notified Medical Devices in India
• Covering Letter,
• Authorization Letter,
• Duly filled Form-8,
• Duly filled Form-9,
• Requisite Fee,
• Duly attested (notarized) and valid copy of Wholesale License for sale and distribution
of drugs and Manufacturing License, Under D&C Act by State Licensing Authority,
• Registration Certificate in Form-41 by CDSCO,
• Import License in Form-10 issued by CDSCO,
• Required documents as per registration certificate in Form-41 issued by CDSCO.[18]

METHODOLOGY
4.3.3 Import procedure:

Application for registration
(Form-40/schedule D(I)/ schedule D(II), power of attorney)
Registration certificate issued by CDSCO

(Form-41)
Application for import license

(Form-8, Form 9)
Import license issued by CDSCO

(Form-10)
4.3.4 Approval of new medical devices

Appl. In form44 as per Schedule Y
TR6 challan
Review of clinical tail protocol, published reports,

Literature, package insert by CDSCO
Evaluation by medical device advisory committee
On basis of recommendations of MDAC
Permission under Rule-122A granted

METHODOLOGY
4.3.5 Regulatory pathway:
Notified medical device
Appoint an Indian authorized agent to interact with the central drugs standard
control organization.
Grant power of attorney to your India authorized agent to manage your registration in India.
File application for your device registration certificate to CDSCO using from 40.
Device manufacturers new to India require form 45 in the support of the form 40 application
Obtain registration certificate form 41 from CDSCO. Certificate is valid up to 3 years
Identify your distributor in India
Apply for import license using forms 8 and 9 available from CDSCO. You must identify
your chosen distributors on these forms as well.
Obtain import license (form 10) from CDSCO. License valid for up to 3 years or until the
registration certificate expires.
You are now authorized to market your device in India.

RESULTS AND DISCUSSION
5. RESULTS AND DISCUSSION
Table 6 comparision of approval process in USA, EU, CDSCO
SLNO Country Definition Legal Approval Process

Framework
USA Any medical Reviewed by Once these applications
1 device or the FDA approved Premarketing
related article, notification (510k) is
including a submitted to FDA to
component part, demonstrate that either
A diagnostic it is safe or effective for
tool or the human use, after
treatment for which marketing of
disease in medical device is
humans or other authorized by FDA.[14]
animals[13]
EUROPE Accessories There are three Determine the
2 including main classification of our
software. And directives device according to EU
/or therapeutic governing the directive and then
purposes, regulations of implement a Quality
required proper medical Management System,
use, devices.[14] and prepare CE marking
manufacturer is technical file and audit
intended to be QMS by notified body.
used by on, Prepare Declaration of
monitoring, for Conformity (DOC) after
humans for obtain the CE marking
diagnostic and and ISO 13485
preventive certificate from notified
purposes of body.[14]
treatment or
illness relief;
injury or any
physiological
process.[13]

RESULTS AND DISCUSSION
INDIA Medical Central Drug CDSCO/MD/GD/CLAA

3 equipment Standard Control CDSCO/MD/GD/IL[16]
includes Organization.[14]
anything from
household
appliances to
computer
software. It can
be used by itself
or in
combination
with other
items, and is
meant to be
used for
diagnosing,
preventing,
monitoring or
alleviating
disease.[13]

SUMMARY AND CONCLUSION
6. SUMMARY AND CONCLUSION
USA, medical device regulation is performed by CDRH. Strict conformity to desired
principles is required to obtain marketing authorization. 510 (k) and PMA are the regulatory
pathways for obtaining marketing authorization in USA. The choice of regulatory pathway
adopted by companies depends primarily upon the complexity of design, potential risk to
health of user and safety of device.
In European Union, CE marking/certification is mandatory for any device to be marketed.
Medical devices are regulated through Notified Bodies and National Authorities in a very
novel fashion. The Notified Body ensures compliance to Quality and Safety standards and
approves devices for CE marking, whereas marketing authorization is granted by Competent
Authority of the member state.
In India, CDSCO regulates handful devices through gazette notifications. These devices are
called notified devices. A few products are classified as drugs in India but are classified as
devices in other countries. This system is not in consonance with international standards.
Existent system appears to be rudimentary in character when compared to regulatory
systems of USA and EU. Therefore revamping of current regulatory system is required for
administration of devices moving in commerce and creating harmonized standards of
medical devices.
From the collected information, it appears regulatory requirements for import / manufacture
/ sale of medical devices are different from country to country and are less rigid in India
when compared with the other two countries USA and Europe.

REFERENCES
7. REFERENCES
1. Maak TG, Wylie JD. Medical Device Regulation: A Comparison of the United States and
the European Union. J Am Acad Orthop Surg. 2016 Aug;24(8):537-43. doi:
10.5435/JAAOS-D-15-00403. PMID: 27195383.
2.https://www.researchgate.net/publication/365823442_The_need_for_action_by_e
valuators_and_decision_makers_in_Europe_to_ensure_safe_use_of_medical_soft ware.
3. Manu M, Anand G. A review of medical device regulations in India, comparison with
European Union and way-ahead. Perspect Clin Res. 2022 Jan-Mar;13(1):3- 11. doi:
10.4103/picr.PICR_222_20. Epub 2021 Jul 12. PMID: 35198422; PMCID: PMC8815674.
4. Chandan B. V., C., Venkatesh, M. P., M., A., Krishna, P. D. and S., I. (2021) “Comparison
of Medical Device Regulations in India, Japan and South Korea”, Journal of Pharmaceutical
Research International, 33(53A), pp. 8-23. doi: 10.9734/jpri/2021/v33i53A33634.
5.https://www.asianhhm.com/technology-equipment/current-scenario-regulation
monitoring-medical-devices
6.Manik G, et al. Comparative Study of Medical Devices in USA, Europe and India.
Pharmaceut Drug Regul Affair J 2022, 5(1): 000132.
7. https://cdsco.gov.in/opencms/opencms/en/Home/
8. https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices
9. Priyadarshini, I., Kumar, R., Tuan, L.M., Son, L.H., Long, H.V., Sharma, R. and Rai, S.,
2021. A new enhanced cyber security framework for medical cyber physical systems. SICS
Software-Intensive Cyber-Physical Systems, 35(3), pp.159-183.

REFERENCES
10. Sethi, R., Popli, H. and Sethi, S., 2017. Medical devices regulation in United States of
America, European Union and India: A comparative study. Pharm. Regul. Aff.
11.Kuntz RE, Leon MB (2004) Medical device development: From Prototype to Regulatory
Approval. Circulation 109(25): 3068-3072
12. India Medical Device Regulations, EMERGO.
13. Risk Management Mentor Program. MedPro Group, pp: 1-33.
14. http://www.emergegroup.com/resources/regulations-india
15. US Food and Drug Administration (2014) Classify Your Medical Device. Department
of Health and Human Services.
16. Pisano DJ, Mantus D (2014) FDA Medical Device Regulation: FDA Regulatory Affairs
3rd (Edn.), CRC Press, USA.
17. http://www.qrasupport.com/FDA_MED_DEVICE.html
18. Ministry of Health and Family Welfare (2013) Guidance Document on Common
Submission Format for Import License of Non Notified Diagnostic kits in India. Central
Drugs Standard Control Organization.
19. http://companiesinindia.net/top-10-medical-device-companies-in india.html
20. World Health Organization (2010) Clinical evidence for medical devices: Regulatory
processes focussing on Europe and the United States of America. Medical Devices.
21. https://www.slideshare.net/surajpamadi/medical-device-regulations-in-india
22.https://www.slideshare.net/zaxotes/regulatory-approval-process-for-medical-devices-in-
eu
23. https://www.fda.gov/


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COMPARATIVE STUDY OF MEDICAL DEVICES

REGULATIONS IN INDIA, US, AND EUROPE

Pharmaceutical Regulatory Science

Under the guidance of

Krupanidhi College of Pharmacy

of Pharmacy .This is to certify that this project has been evaluated

Internal Examiner External Examiner

We hereby declare that this Project work entitled “COMPARATIVE STUDY OF

MEDICAL DEVICE REGULATIONS IN INDIA, US AND EUROPE” is a bonafide and

genuine research work carried out by us under the guidance of

Dr. Eswar Gupta Maddi, Professor, Krupanidhi College of Pharmacy, Bangalore.

DEVICE REGULATIONS IN INDIA, US AND EUROPE” is a bonafide research work

requirement for the degree of Bachelor of Pharmacy.

Date: Signature of the Supervisor

DEVICE REGULATIONS IN INDIA, US AND EUROPE” is a bonafide research work

Dr. Eswar Gupta, Professor, Krupanidhi College of Pharmacy, Bangalore.

Seal & Signature of the HOD Seal & Signature of the

Declaration by the Candidate

We (Aleena Joshy, Anusha S, Harshashree M and Kavya S M of Krupanidhi College of

print or electronic format for academic/ research purpose.

Date: Signature of the Candidates

Place: Aleena Joshy

© Rajiv Gandhi University of Health Sciences, Karnataka

my gratitude to all of them.

could never have been fulfilled.

We take this opportunity to express my heartfelt gratitude and indebtedness to my respected

guide Dr. Eswar Gupta, Professor, Department of Pharmaceutics, Krupanidhi College of

B.Pharm academic programme.

We further avail this opportunity to thank all faculty members of Department of

unconditional love, support and care.

Date: Signature of the Candidates

Place: Aleena Joshy

Sl.No Abbreviations Full Form

1 CDSCO Central drug standard control organization

2 DCGI Drug controller general of India

3 BMR Batch manufacturing record

4 D&C ACT Drug and cosmetic act

5 CLAA Central licensing approval authority

6 MDAC Medical device advisory committee

7 ISO International organization of standardization

8 MDR 2017 Medical device rules 2017

9 SOP Standard operating procedure

10 CLA Central licensing authority

11 USFDA United states of food and drug administration

12 QSR Quality system regulation

13 GMP Good manufacturing practices

15 IDE Investigational device exemption

16 CFR Code of federal regulation

17 PMA Premarket approval

18 PMN Premarket notification

19 CDRH Center for devices and radiological health

20 AIMDD Active implantable medical device

21 EEC European economic commitee

25 EAR European authorized representative

26 CER Clinical evaluation report

27 MDR Medicinal device regulation

28 EMA European medical agency

29 STED Summary of technical documentation

30 DOC Declaration of conformity

31 SMF Site master file

32 NB-MD Notified body medical device

33 IVDMDD In-vitro diagnostic medical device directive

Sl. No. Tables Page No.