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Journal of Drug Design and Research
Research Article *Corresponding author
Nitika Agrahari, Drug Regulatory Affairs, Acharya &

Gap Assessment on New BM Reddy College of Pharmacy, Bеngaluru-560107,

Karnataka, India, Tel: 918003838674; Email: nikky4745@
gmail.com

Medical Device Rules in India Submitted: 11 May 2021

Accepted: 27 May 2021
Published: 29 May 2021

and EU ISSN: 2379-089X

Copyright
© 2021 Agrahari N, et al.
Nitika Agrahari*, Cs Lakshameesha, Divakar Goli, and Neha
Chauhan Awadhesh OPEN ACCESS
Drug Regulatory Affairs, Acharya & BM Reddy College of Pharmacy, India
Keywords
• EUMDR
Abstract • CLA
Medical Device is an emerging market. The specific areas of application and extent of usage of medical • Importer
devices is ever increasing throughout the world and becoming more and more sophisticated with every passing • CE marking
year. Regulations of Medical Devices vary from country to country. European Medical Agency (EMA) regulates • Notified bodies
medical devices in EU while the Central Drug Standard Control Organization (CDSCO) is its counterpart in India. • CDSCO
Recently introduced guidelines and various amendments provide adequate guidance for the manufacturers,
distributors and competent authorities to manage various activities and regulatory processes in an efficient
manner. They perform a gap analysis of various regulatory frameworks of their business interests in order to
thoroughly understand the inputs required for regulatory approvals across geographic territories. This research
highlights comparative study of current regulations in India and EU, pertaining to applications for medical device
registration certificates and medical device manufacturing/importation licenses. The recommendations are to be
expected to implemented and regulated properly with effective outcome.

INTRODUCTION Classification
Medical device is any instrument, implement, device, In line with world rules and regulations, there are new
appliance, machine, implant, reagent for in-vitro use, material, rules which are introduced based on the risk the new rules for
software or other similar or related article, intended by the classification.
manufacturer to be used in combination or alone, for human
Medical Devices are classified by CDSCO and it will periodically
beings, wherein the software required by its manufacturer
publish the classified medical devices on website. To classify the
is intended to be used exclusively for therapeutic/diagnostic
medical devices the importers and manufactures should follow
purpose and vital for its proper application for one or more of the
the below mentioned classification list (Table 1).
specific medical purpose(s) of:
If the medical device classification is in higher grade especially
a) Diagnosis, monitoring, preventing, alleviation or treatment
in GHFT countries here also it will be considered as higher grade
of disease,
medical devices.
b) Examination, modification, support or replacement of the
European Union
physiology processor anatomy,
On 25 May 2017 the latest MD Regulation (EU) 2017/745 and
c) Life sustaining or supporting or system,
IVD Regulation (EU) 2017/746 come into effect. This replaces
d) Conception control [1]. the 3 Directives which is existing beginning from May 2020
(for MDs) and from mid-2022 (for IVDs). The producers were
India
granted this transitional phase to conform to the current MD
In June 2005, CDSCO in India produced Medical Device
guidelines and in Jan2017, MOH notified through GSR. 78
(E) the separate guideline for “Medical Devices Rules, 2017” Table 1: Classification of Medical Devices [3].
which came into force from 1st Jan 2018. Before implementing CLASS RISK LEVEL
the Medical Device rules of the Medical Device Rules, ‘notified CLASS A Low
medical devices’ were considered as pharmaceutical drugs in
CLASS B Low-moderate
India according to the Drug and Cosmetic Act, 1940. Hence, it was
CLASS C Moderate-high
necessary to have separate guidelines for pharmaceutical drugs
and medical devices [2]. CLASS D High

Cite this article: Agrahari N, Lakshameesha C, Goli D, Awadhesh NC (2021) Gap Assessment on New Medical Device Rules in India and EU. J Drug Des Res
8(2): 1083.
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/ IVD regulations. Until the time as NBs have been assigned to into the nation before the date of the notification, the import is
certify against both the newly introduced regulations, all the MDs not authorized. The permission of the competent authority is
must meet the important/essential requirements set out in the needed for the importation of medical devices into India. Certain
directives [4] (Table 2). products that are already in use are placed introduced in the
market for a certain period of time until the request made is
Table 2: Classification of Medical Device as per EUMDR [5]. denied or accepted [6].
Classes Risk Description Example
Chapter 5 of the MDR 2017, deals with the import of medical
Reusable sterile surgical Sterile gloves. Dress-
Class I- sterile devices for marketing and distributing in the Indian market.
instruments ings, others.
International manufacturers may select a competent Indian
Provided sterile and/or
Class I- measuring has a measurement func- Volumetric urine bag
agent to carry out PMS operations and medical device delivery
tion (low/medium risk); by holding the license. Any authorized agent who already had a
Provided non-sterile or license for manufacturing the medical devices for the purpose of
Class I- basic will not have measure- Non-Sterile Gloves distribution or sale may request for an import license shall be
ment feature (low risk) presented to the CLA for all classes of medical devices. Indeed,
Suction equipment, any wholesaler planning to produce medical devices for import
Class IIa medium risk
Surgical Blades. must request for an import license. The mechanism for licensing
Radiotherapy equip- is governed through MoHFW under central government. The
Class IIb Medium to high risk ment, orthopedic ministry has an electronic database, from which the demand
implants for an import license will be rendered. Use Form MD-14, the
Drug-eluting cardiac submission is submitted with the regional licensing authority.
Class III High-risk stents, Absorbable
Sutures, AIMD As well, the individual is required to present several other
documentation together with the verification form. First of all, the
OBJECTIVES submission must have a cover letter in an appropriate template,
•• To review regulatory framework for import registration. and the application must have the correct details. In addition, the
applicant may apply for a valid Indian medical device distributor
•• Potential Impact of Medical Devices Regulation, 2017/745 wholesale/manufacturer permit. This is an essential condition
•• To compare the detail regulations of Medical Device in EU for submitting a request. The purchaser always needs to present
and India to address compliance. the submission with FSC. A certificate signifies the manufactured
medical devices are openly available into the selling country’s
METHODOLOGY open market and are allowed for sale and trade globalization is
The research carried out with the collected data by analyzing said to be Free Sale Certification.
the terms of the below parameters: The supporting documentation often include standard
1. Internet using official web page certificates from international manufacturers guaranteeing good
quality of the product being imported. A DMF  that describes
2. Overview of Regulatory Guidelines  the importing medical device technological, health, and safety-
3. Review and compilation of documents related information and test data. The application should also
include a PMF which describes specifics of the medical device’s
RESULT AND DISCUSSION manufacturing process.
Medical Device Registration and Import Regulations In India, there are many items requiring registration
in India including spinal pins, heart valves, syringes, annuloplasty tubes,
and needles, cardiac stents, cochlear implants, catheters, etc.
Registration Procedure: In  India, for the medica1 devices Any business company that wants to license or import medical
import, registration and import permits are essential. Therefore, devices lawfully into India must abide by the rules laid down
an individual who is likely to import medical devices into India in the New Medical Device Regulation 2017 of CDSCO. In case,
must obtain a certificate of registration and import permit. Both in India, there is no registered office of the organization, then
production and import license applications are dealing with thru the organization will need to appoint an “authorized agent”
an online portal, SUGAM— an online licensing program is part of to manage the registration processes and other functions. An
the MoHFW. “authorized agent” is the one who have a very important role in
SLA shall control the manufacturing authorization for the registration process and is also authorize for the follow-up
products of Class A and B medical device, and the prerequisite actions. (7-8)
for Class C and D licenses will be referred to the CLA. A Quality 1. Business activity
Assurance Report (QAR) of Class B, C and D goods must be
published in accordance with manufacturing license; By 2. PMS
comparison, a QAR for medical devices under Class A has to be 3. Pre-certification (Figure 1).
issued within 4 months from the authorization date of the license
for manufacture. In the event that products were not shipped Medical Devices import procedure in India: A list of doc-
umentation  is  required  for  importation  of  medical  devic-

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Figure 1 Process of Obtaining Registration [9,10].

es to be submitted with Form MD 14 (Table 3) (Figure 2). 2017/745: (Table 5 and 6).

Registration Certificates: The 2017 Rules also eliminated CONCLUSION
the need for a certificate of approval to recognize an internation-
al manufacturer its location and the goods. Presently we have to The changes made by Medical Devices Rules 2017 are an-
make two separate applications to import and marketing prod- ticipated to allow more multinational companies (MNC) to build
ucts in India (registration and import license). The international manufacturing facilities for medical devices in
distributor shall designate an authorized agent in India after the •• From this research project it is inferred that no such strict
start of the Rules 2017 and is applied to get import license to get regulations and rules for the import, production, and sell-
imported and marketed devices into the nation. After 9 months ing of medical devices existed till 2017.
the claimant will be issued an import permit.
•• The approved medical devices need to carry unique de-
In India, renewal process for certificates is far less rigorous vice  identifiers by 2020. Medical devices licensed for
when compared to other countries. For retaining certificate’s manufacture, selling or delivery in India shall carry two
permanent validity, the applicant should incur an annual renew- different types of unique identifiers, beginning on January
al, maintenance charge of Rupees 20,000 (about $310) every 5 1st, 2022 to ensure safety and effectiveness, the govern-
from years from the issuance date [12] (Table 4). ment is setting up research labs in the country to address
Potential Impact of Medical Devices Regulation, shortcomings in medical device goods.

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Table 3: List of Document to be Submitted with Form MD 14.

SL. No. DOCUMENTS SL. No. DOCUMENTS
1. Covering Letter 2. Power of Attorney
3. Wholesale License 4. Free Sale Cert.
5. Audit Report for past 3 years 6. ISO 13485 Cert.
7. Full Quality Assurance 8. CE Design Certificate
9. 510K cert 10. Decl. of Conformity
Plant Master File
• General Information
• Personnel
• Premises and Facilities
• Equipment
• Sanitation
11. • Production 12. DMF- Executive Summary
• Quality Assurance
• Storage
• Documentation
• Medical Device Complaints and Field Safety Corrective Action
• Internal Audit
• Contract Activities
13. Subsequent Equivalence 14. Labels and IFU
15. Device Design and Manufacturing Process Flow Chart 16. Essential Principles Checklist
17. Risk Analysis and Control Summary 18. Design Verification and Validation
19. Bio-compatibility 20. Medicinal Substances Data
21. Biological Safety (TSE/BSE) 22. Sterilization Validation Data
23. Software Validation/ verification 24. Animal Studies Preclinical Data
25. Stability Validation Data 26. Clinical Evidence
27. Post Marketing Surveillance 28. Batch Release certificate
Notarized Copy of Overseas Manufacturing Site or establishment or plant Constitution Details of Authorized
29. 30.
registrations in Country of Origin issued by Competent Authority Indian Agent
Approval process for Application through Online Sugam Portal [11].

Figure 2 Application for Import License via SUGAM Portal every 5 from years from the issuance date [12].

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Table 4: Timeline to obtain Manufacturing/ Import License for Medical Device.

Class/Timeline Class A Class B Class C Class D
Manufacturing License 45 Days 140 Days 150 Days 150 Days
Import License Within 9 months

Table 5: Potential Impact of Medical Devices Regulation, 2017/745 [13].

Parameter Change Potential impact
Mainly impacted on the industrial regulators and increased
Scope of devices In new regulation include the some cosmetic devices and the
training and the consultancy work increases for newly
regulated devices using non-viable human tissues
included devices
Shortage of the resourced validated notified bodies
Mainly on the selection of notified body (NBs) with
Validation of and strict requirements for present NBs and increased
detailed criteria and the monitoring to notified body about
notified bodies biocompatibility assessments and the higher costs and
requirements.
longer time periods for approval to manufacturer’s

Providing the more health safety and efficiency information

details of high-risk devices and the supporting clinical The more importance on the test laboratory selection and
investigation data and increased work for NBs for the increased release testing and must should be compliance to
providing data for EU reference laboratories which is validated current standards and More need in biocompatibility
for testing. /performance test training.
The second look by the NBs for the biocompatibility for high
risk devices, and authorization to conduct the confirmatory Increased interpretation of requirements and standards
testing, NBs analysis of relevant laboratory results, and the and less tolerance for gaps in biocompatibility and enhance
unannounced inspection of premises by NBs of the high risk monitoring of controls on change.
Device testing and
MD premises (e.g. Annually for class III devices)
inspection
Robust requirements and improved PMS, increased Potential for higher expense for manufacturers and supplier
Surveillance
coordination in vigilance case analysis and reactions Lawsuits.
The organization of a well-qualified person who will be
Manufacturer responsible for regulatory compliance and increased Increased in demand of qualified personnel and increase the
staffing manufacturer’s resource needed and costs increases
Responsibility
Comparison of Medical Device in EU and India [14,15]

Table 6: Comparison of Medical Device Regulation in EU and India.

SL. No. Point of European Union India
Comparison
1. Regulatory EMA and RA of member state CDSCO
Authority
2. Definition of ‘medical device’ means any instrument, apparatus, appliance, medical devices including software or an accessory,
Medical device software, implant, reagent, material or other article intended intended by its manufacturer to be used specifically
by the manufacturer to be used, alone or in combination, for human beings or animals which does not achieve
for human beings for one or more of the following specific the primary intended action in or on human body or
medical purposes: animals by any pharmacological or immunological or
• Diagnosis, prevention, monitoring, prediction, prognosis, metabolic means but which may assist in its intended
treatment or alleviation of disease function by:
• Diagnosis, monitoring, treatment, alleviation of, or • Diagnosis, prevention, monitoring, treatment
compensation for, an injury or disability or alleviation of any disease or disorder
• The investigation, replacement or modification of the • Diagnosis, monitoring, treatment, alleviation
anatomy or of a physiological or pathological process or or assistance for, any injury or disability
state, • The investigation, replacement or
• Providing information by means of in vitro examination modification or supporting anatomy or a
of specimens derived from the human body, including physiological process
organ, blood and tissue donations and which does not • Supporting or sustaining life
achieve its principal intended action by pharmacological, • Disinfection of medical devices, and
immunological or metabolic means, in or on the human • Control of conception
body, but which may be assisted in its function by such
means.

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3. Classification Class I Class A

Categories Class II Class B
Class III Class C
Class IV Class D
4. Regulatory Multiples Pathways Market Authorization Application to Competent
Pathway Authority
5. Fees for Fees for available pathways Import License:
available For class A and B
pathways $ 1,000- Registration Fee
$ 50- Premises Registration
For class C and D
$ 1,500- Registration Fee
$ 3000- Premises Registration
6. Quality ISO 13485 ISO 13485:2016
Management
Systems
requirement
7. Technical Data EMA CDSCO
Assessment
performed by
8. Requirement for Responsible person registration Premises Registration
establishment
Registration
9. Regulation of EU MDR 2017/745 Medical Device Rule 2017
Medical Device
10. Validity of The validity of CE marking is for Class I- Indefinite. 5 years from the date of approval, for Notified
License Class IIa, IIb and III-3 years. Devices.
11. Requirement • Single Administrative Document • Covering Letter
of document • Economic operator Registration and Identification • Power of Attorney
for import • CE marked Certificate • Wholesale License
registration
• EU declaration of Conformity • Free Sale Cert.
• The manufacturer is identified and that an authorized • Audit Report for the past 3 years
representative. • ISO 13485 Cert.
• Label and IFU • Full Quality Assurance
• Unique Device Identifier • CE Design Certificate
• Biological Safety(TSE/BSE) • 510K cert
• unique identification of devices • Decl. Of Conformity
• clinical investigations • Plant Master File
• vigilance and post-market surveillance • DMF- Executive Summary
• Regulatory certification • Subsequent Equivalence
• Product Validation and Verification Report • Labels and IFU
• Audit Report • Device Design and Manufacturing Process Flow
• Clinical evaluation and PMCF Chart
• Correlation table • Essential Principles Checklist
• An assessment of conformity based on a quality • Summary of Risk Analysis and control.
management system and technical documentation • Design Verification and Validation
• An assessment of conformity based on type examination • Biocompatibility
• An assessment of conformity based on verification of • Medicinal Substances Data
product conformity • Biological Safety(TSE/BSE)
• Certificates issued by NB • Sterilization Validation Data
• Custom-made devices procedures. • Software Validation/ verification
• Summary of the Risk Analysis and Control • Animal Studies Preclinical Data
• Device Design and Manufacturing Process Flow Chart • Stability Validation Data
• risk assessment of phthalates presence. • Clinical Evidence
• Infection and microbial contamination • Post Marketing Surveillance
• Medicinal Substances Data • Batch Release certificate
• Devices construction and interaction with their • Notarized Copy of Overseas Manufacturing
environment Site or establishment or plant registrations in
• Pre-clinical and clinical data Country of Origin issued by Competent Authority
• Constitution Details of Authorized Indian Agent

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12 Labeling (a) the name and address of the manufacturer or trade a) Medical device Name and description
Requirements name b) the details needed to identify the device and
(b) where appropriate, the word ‘STERILE’; the use for the user.
(c) Detail necessary to identify the device and its use for c) manufacturer name and address.
the user. d) Net quantity
(d) manufacturing date and expiry date; e) Manufacturing and expiry date (month and
(e) EU representative being on both the label and not year)
explicitly requiring that representative to be on the f) An indication that a medicinal or biological
IFU. substance is present in the device, if
(f) the CMR/ endocrine disruptors over 0.1 percent by required.
weight g) Lot no. preceded by the word ‘’Lot’’ or
(g) Unique Device Identification (UDI) ‘’Batch no.’’ also known as
(h) Expiration date by using the word as ‘using’ or Production identifier
‘implanting’; h) Storage condition applicable to the device;
(i) An indicator, where appropriate, of the date by which i) To indicate, if a device is delivered as
the device should be used, in safety, expressed as the a sterile product, its sterile state and
year and month sterilization method.
(j) Manufacturing year for active devices other than j) Warning or precaution;
those referred to in (e). This indication may be k) To label the device appropriately, if the
included in the batch or serial number; device is intended for single use;
(k) any special condition regarding storage and/or l) ‘’Physician sample-Not to be sold”, if a
handling; medical device is intended to be distributed
(l) where applicable, method of sterilization; as free sample to a medical professional.
(m) any warnings and/or precautions which must be m) Manufacturing license no.
taken; n) Unique Device Identification (UDI)
(n) an indication that the device contains a derivative of o) Device identifier no.
human blood. p) If a device is used for import, import license
(o) Where the device is a reprocessed single-use device, no. , name and address of the importer.
the number of reprocessing cycles performed and any
limitation on the number of reprocessing cycles shall
be indicated.
(p) if the device is custom-made, using the term 'custom-
made device'
(q) the words 'exclusively for clinical examination' where
the device is designed for clinical investigation;
'Overall qualitative structure' and 'quantitative
knowledge on the key components responsible for
performing the specific planned intervention' for
devices made up of ingested or locally distributed
compounds.
(r) 'batch number previous to the word ‘Lot or serial no.’
13. Certificate of Mandatory Not required
suitability
14. TSE/BSE free Mandatory only Once products containing components of Not required
statement biological origin
15. CRO (Audits) Audited by MHRA CDSCO
16. Reserve Sample No such Requirement No such Requirement
17. Unique device ‘UDI system’ shall composed of : With impact from 1 January 2022, a medical product
Identification (a) manufacture of a UDI may include: has been licensed for sale or delivery or import
of the medical (i) manufacturer and device-specific UDI device identifier and export shall bear a UDI containing the device
device (UDI) ('UDI-DI'), providing access to the information provided for identifier and the identification of the production.
Annex VI Part B; Explanation.- To the end of this rule,-
(ii) an UDI production identifier ('UDI-PI') identifying "Device identifier" implies the global trade items no.;
the device manufacturing unit and, where applicable, the
packaged devices as set out in Part C of Annex VI; (ii) "Production identifier" includes the serial
(B) place the UDI on the device package or label; number, lot or batch size, medical device type
(C) Installation of UDI by economic owners, healthcare program, date of manufacture and/or expiry.
institutions and healthcare practitioners, in compliance with
the requirements laid down in paragraphs 8 and 9 of this
Article;
(D) Electronic 'UDI database' established in accordance with
Article 28.
18. Shelf life 5 years The Medical Device's shelf-life shall not exceed 60
months from the expiration date.

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Cite this article

Agrahari N, Lakshameesha C, Goli D, Awadhesh NC (2021) Gap Assessment on New Medical Device Rules in India and EU. J Drug Des Res 8(2): 1083.

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