REGULATORY AFFAIRS &

INTELLECTUAL PROPERTY
(Medical devices and in-vitro
Diagnostics)

BY:
SHIVANI TANWAR

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 AGENDA
DAY 1
1. Introduction to the Life Sciences Industry and Applicable Regulations
2. Fundamentals of Research and Development in Medical Devices and In-vitro Diagnostic Devices (IVD)
3. Development of Technical Dossier guidelines for medical devices and In-vitro Diagnostic Devices (IVD)

DAY 2
4. Submission of Technical Dossier as per the Regulatory Guidelines
5. Managing the Regulatory Affairs for Medical Devices and In-vitro Diagnostic Devices (IVD)
6. Managing Intellectual Property Rights for Medical Devices and In-vitro Diagnostic Devices
7. Coordination with Manager, Teammates and Auditors and Display Sensitivity Towards Genders and
People with Disabilities

DAY 3
8. Comply EHS Rules at Workplace
9. Employability Skills
10.Entrepreneurial Activities to Start and Run the Business Operations
11. Manage the Critical Documents for Business Activities and Statutory and Regulatory Compliance

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European Union Medical Devices
Regulation (MDR)

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 European Union Medical Devices Regulation (MDR)
• The Medical Device Regulation
(MDR) replaced the EU’s original
Medical Device Directive (93/42/EEC
MDD) and the EU’s Directive on
active implantable medical devices
(90/385/EEC AIMDD).
• MDR came into force on 25 May
2017 and became applicable on 26
May 2021.
• Transition Period:
 On 15 March 2023, the European
Union extended the EU MDR
transition periods:
 26 May 2026 for class III implantable
custom-made devices.
 31 December 2027 for class III and
implantable class IIb devices.

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 Medical Device Definition

 ‘Medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or
other article intended by the manufacturer to be used, alone or in combination, for human beings for one
or more of the following specific medical purposes:
 diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
 diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
 investigation, replacement or modification of the anatomy or of a physiological or pathological process
or state,
 providing information by means of in vitro examination of specimens derived from the human body,
including organ, blood and tissue donations,
and which does not achieve its principal intended action by pharmacological, immunological or metabolic
means, in or on the human body, but which may be assisted in its function by such means.

The following products shall also be deemed to be medical devices:

• devices for the control or support of conception;
• products specifically intended for the cleaning, disinfection or sterilization of devices as referred to in
Article 1(4) and of those referred to in the first paragraph of this point.

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 Medical Device Classification (Annexure VIII)

 Risk classification is based on intended use, type of medical device, patient exposure,
duration of use, invasiveness, severity of harm and level of risk.

•Class I – Provided non-sterile or do not have a measuring function (low risk)

•Class Is/Im/Ir – Provided sterile and/or have a measuring function (low/medium risk);
reusable surgical instruments as Class I reusable surgical instruments.
•Class IIa (medium risk)
•Class IIb (medium/high risk)
•Class III (high risk)

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 Regulatory Approval Process

 A medical device can only be placed on the European market once the manufacturer declares conformity of the device
with applicable European Union (EU) regulations.
 Manufacturers provide evidence for conformity with the applicable regulations using a set of documents called
Technical Documentation that comprehensively describe the medical device, including, among many other aspects, the
intended purpose, design, manufacturing, verification and its validation.
 The expected content of a TD is set out in Annexes II and III of EU MDR 2017/745 and EU 2017/746 (IVDR).
 Class I devices: self-certified (Technical File need not to be audited by a notified by prior to obtaining a CE mark)
 Class IIa, Class IIb, and Class III: need a Technical File or Design Dossier (for Class III devices) audited by a Notified Body.

Conformity Assessment: Systematic

CE marking (or CE Quality Management System
Notified bodies: are examination of evidence generated and
mark): The product (QMS): ISO 13485:2016 -
accredited by the EU to “Quality Management for procedures undertaken by the
complies with the
conduct regulatory Medical Devices”, it details manufacturer by complying all regulatory
essential
audits and ensure you the provisions for building requirements to ensure a medical device is
requirements of all
are meeting the QMS that cover the safe and performs as intended and thus,
the relevant requirements relating to
regulatory conforms to the Essential Principles of
legislation outlined quality management in the
requirements. Safety and Performance for medical
in the regulation. MDR.
devices.

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 Annex II - Technical Documentation
Key Area Description
Device • Product name, general description, intended purpose, whether the device is working
description as stand-alone or used in combination with accessories or other products, intended
users, Basic Unique Device Identification-Device Identifier (UDI-DI), intended patient
population, indications, contra-indications, warnings, principles of operation,
• Rationale for the qualification of the product as a device, novel features, accessories,
different variants of the device.
• key components and their composition in terms of raw material and the type of
contact with the body, technical specifications, previous generation of devices and
similar devices on the market
• Risk classification of the device and its rationale

Information to • Label(s)
be supplied by • IFU in all languages as per selling markets
the manufacturer • Implant cards (if applicable) with device name, serial number, lot number, UDI and device model,
as well as the name, address and website of the manufacturer
• Declaration of conformity (as per Annex IV)

General safety GSPR checklist, including Methods for Demonstrating Conformity; identification of
and performance applicable standards
requirements
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 Annex II - Technical Documentation
Key Area Description
Design and • Design stages and manufacturing flowchart (detailing steps that are outsourced),
manufacturing validation status of processing steps, process controls performed (incoming, in-process
information and end-controls) and the corresponding sampling sizes, specification of final (release)
product and testing, acceptance criteria, intermediate cleaning stages, etc.
• Critical supplier (including subcontractors) list
• History of changes (“design history file”, at least the summary)
• Description of working environment (classification and controls)
• Master Validation Plan and Reports of processes considered critical
• Raw material specification, Bill of material, Subcontracting information
• Part drawings, Assembly drawings
• Test equipment

Benefit-risk • Risk management plan

analysis and risk • Risk analysis (which includes risks related to design, manufacturing and use of the
management device)
• Risk management report

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 Annex II - Technical Documentation
Key Area Description
Product • Preclinical Verification and Validation reports
verification • All test plans and reports including:
and validation ▢Biocompatibility, including material identification for patient or user contact.
including clinical ▢Physical, chemical, and microbiological characterisation.
evaluation ▢Electrical safety and electromagnetic compatibility.
▢Software verification and validation, describing the software design and
development process, validation evidence, and results of verification, validation,
and testing.
▢sterilization and sealing of packaging before sterilization; Stability, including
shelf life.
▢Device performance and safety.
• Clinical evaluation plan and report, as applicable
• Clinical development strategy and Clinical Development Plan for the device.

Post-market • Post-market surveillance (PMS) plan and report (or periodic safety update report
surveillance (PSUR))
• Post-market clinical follow-up (PMCF) plan and report
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 Annex II - Technical Documentation
Key Area Description
Product • Preclinical Verification and Validation reports
verification • All test plans and reports including:
and validation ▢Biocompatibility, including material identification for patient or user contact.
including clinical ▢Physical, chemical, and microbiological characterisation.
evaluation ▢Electrical safety and electromagnetic compatibility.
▢Software verification and validation, describing the software design and
development process, validation evidence, and results of verification, validation,
and testing.
▢sterilization and sealing of packaging before sterilization; Stability, including
shelf life.
▢Device performance and safety.
• Clinical evaluation plan and report, as applicable
• Clinical development strategy and Clinical Development Plan for the device.

Post-market • Post-market surveillance (PMS) plan and report (or periodic safety update report
surveillance (PSUR))
• Post-market clinical follow-up (PMCF) plan and report
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 Clinical Evaluation Report (CER) and Performance Evaluation Report (PER)
• A clinical evaluation is required for every medical device sold in the EU, regardless of risk classification.
• The Clinical Evaluation Report states the clinical benefits and safety characteristics of the device, based on
clinical data. It is the output of the Clinical Evaluation Plan.
• Clinical Evaluation Report (CER) as well as a Performance Evaluation Report (PER) is a crucial step in ensuring
the safety, efficacy, and performance of medical devices and in-vitro diagnostic (IVD) devices.

Part 1: Creating a Part 2: Identifying

Part 4: Writing your
Process and Relevant Data and Part 3: Analyzing
Clinical Evaluation
Establishing Creating a Literature Your Clinical Data
Report (CER)
Equivalency Review Protocol

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 Clinical Evaluation Report

While the content of the Clinical Evaluation is simple, writing it, coming up with the right structure and
forming a sensible line of reasoning (equivalence) can be a bit tricky.
Following are the guidance documents on Clinical Evaluation:
• MDCG 2020-1, 2020-5, 2020-6
• MDCG 2020-13: Quite helpful as it gives you an idea of the structure.
• MEDDEV 2.7/1 Rev. 4. (mostly for MDD, but still a good starting point; especially the list of proposed
headings for a report at the end of the document).

Finally, this Clinical Evaluation Report is for Medical Devices.

Fort IVDs, Performance Evaluation Report which has many similarities but some essential parts are
different, e.g., Post-Market Performance Follow-Up and procedural descriptions of evaluation and
validation).

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Components of CER Components of PER
• It is crucial to understand the key components of a
1. Device Description and Intended Use Performance Evaluation Report.
2. Performance Testing • Focused on assessing a medical device's performance
3. Validation and Verification characteristics, intended use, and technical
specifications.
4. Clinical Literature Review
• This report is required to demonstrate that the device
5. Risk Assessment performs as intended and meets its intended purpose,
6. Clinical Data Analysis often covering aspects such as accuracy, precision,
7. Clinical Evaluation Summary sensitivity, specificity, and other relevant technical
8. Post-Market Clinical Follow-up parameters.
(PMCF) Plan
1. Device Description and Intended Use
2. Performance Testing
3. Validation and Verification
4. Comparative Analysis
5. Risk Assessment
6. Performance Evaluation Summary
7. Post-Market Performance Monitoring

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 Design Dossier for CE Marking applications
Steps involved:
Step 1: Understand Regulatory Requirements
Step 2: Determine Applicability
Step 3: Collect Technical Documentation
Step 4: Quality Management System (QMS)
Step 5: Design and Development Documentation
Step 6: Risk Management
Step 7: Clinical Data
Step 8: Labelling and Instructions for Use
Step 9: Performance Testing
Step 10: Manufacturing and Quality Control
Step 11: Document Organization and Compilation
Step 12: Regulatory Submissions
Step 13: Ongoing Compliance
Step 14: Collaboration and Expertise

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 Declaration of Conformity (DoC)
• An EU declaration of conformity (DoC) is a
The EU Declaration of Conformity must be on the
mandatory document that you as a
company’s official letterhead.
manufacturer or your authorized representative
need to sign to declares that the medical • Name and full address of the manufacturer.
device/in-vitro diagnostic device complies with • Medical Device Name.
the requirements of MDR/IVDR and all the Union • Brand Name (If the applicable model/variant).
legislation applicable to the device. • Device Risk Classification.
• List of Harmonized Standards applied.
• The declaration of conformity needs to be • Declaration statement.
continuously updated by the manufacturer. • European Authorized Representative Name, full
address, and contact information
• Notified Body name and Address (Not applicable for
• The EU MDR Declaration of Conformity must be
Class I devices).
prepared as per MDR 2017/745, article 19 & • Name and designation of the person authorized to
annex IV for Medical Device and IVDR 2017/746 sign.
article 17 & annex IV for Diagnostic Devices. • Signature of the authorized person.
• Date and place of signing the DOC.

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 ISO Standards
The International Standardization Organization (ISO) is an independent, nongovernmental organization that has
created thousands of international standards for numerous industries, including medical devices.
1. ISO 13485
MEDICAL DEVICES — QUALITY MANAGEMENT SYSTEMS — REQUIREMENTS FOR REGULATORY PURPOSES
ISO 13485 specifies the requirements for a medical device manufacturer’s quality management system (QMS). The standard
outlines the QMS requirements necessary to prove that the manufacturer is able to produce safe and effective medical
devices that meet user needs and comply with all applicable regulations.

2. ISO 14971
MEDICAL DEVICES — APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
ISO 14971 specifies the process for risk management of medical devices, software as a medical device (SaMD), and in vitro
medical devices. The standard outlines a process for medical device manufacturers to identify hazards, evaluate the risks
associated with them, and implement risk controls.

3. ISO 11135
STERILIZATION OF HEALTH-CARE PRODUCTS — ETHYLENE OXIDE — REQUIREMENTS FOR THE DEVELOPMENT,
VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES

4. ISO 14155
CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS — GOOD CLINICAL PRACTICE
N.S.D.C
 Structured Product Labels (SPLs)
These are standardized XML-based documents that provide detailed product information for submission to
regulatory agencies.
1. Select the Software: The first step is to choose a software tool capable of generating and editing SPLs.
PharmaReady, XForms, and similar tools are designed to facilitate the creation of structured product labelling
documents.
2. Gather Product Information: Then associates would need to collect all relevant product information, including:
• Product name, dosage form, strength, and route of administration.
• Active ingredients and their strengths.
• Indications and usage instructions.
• Warnings, precautions, and contraindications.
• Adverse reactions and clinical pharmacology.
• Manufacturing and labelling details.
• Controlled substance status (if applicable).
• Reference standards, such as Drug Master Files (DMFs).
3. Launch the software and create a new project or file for the specific product associates are working on.
4. Populate SPL Sections
5. Structured Product Labeling tools like PharmaReady and XForms often use structured fields and templates to
ensure data is correctly formatted and compliant with regulatory standards.

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 Structured Product Labels (SPLs)

6. Review and Verify Data

7. Formatting and Styling
8. Compliance Check
9. Generate XML Output
10. Editing and Updating
11. Validation and Testing
12. Submit the generated and validated SPL XML file to the appropriate regulatory
agency according to their submission requirements

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 Label Proofing and Artwork Review
Text verification software, such as TVT (Text Verification Tool) or similar tools, can greatly assist in
verify the accuracy and compliance of product labels, packaging, and artwork before they are finalized
and sent for production.

KeyKeyFunctions
Functions of
of Text VerificationSoftware
Text Verification Software
1. 1.Text
TextComparison
Comparison
2. 2.Content
ContentVerification
Verification
3. 3.Language
Languageand
andTranslation Accuracy
Translation Accuracy
4. 4.Font
Fontand
andFormatting
Formatting Consistency
Consistency
5. 5.Regulatory
RegulatoryCompliance
Compliance
6. 6.Barcode
Barcodeand
andData
DataMatrix Verification
Matrix Verification
7. 7.Customizable
CustomizableRules
Rulesand
and Checks
Checks
8. Customizable Rules and Checks

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 Patient information Leaflet (PIL) and Package Insert
Text verification software, such as TVT (Text Verification Tool) or similar tools, can greatly assist in
verify the accuracy and compliance of product labels, packaging, and artwork before they are finalized
and sent for production.
Steps of Text Verification Software
1. Regulatory Guidelines and Requirements
2. Cross-Functional Collaboration
3. Content Identification and Compilation
4. Tailored Communication
5. Comprehensive Review
6. Risk Communication and Warnings
7. Dosage and Administration Instructions
8. Visual Aids and Formatting
9. Multilingual Considerations
10. Patient-Centric Approach
11. Quality Control and Review Cycle
12. Version Control and Document Management
13. Submission and Documentation
14. Continuous Monitoring and Updates

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India Medical Devices Regulations (India
Medical Devices Rules 2017)

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 Medical Device Definition
 All 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 ―
(i) diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder;
(ii) diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability;
(iii) investigation, replacement or modification or support of the anatomy or of a physiological
process;
(iv) supporting or sustaining life;
(v) disinfection of medical devices; and
(vi) control of conception.
 Since 1st April 2020, all medical devices (including its accessories and components) are regulated
as drugs in India. An import license has been made mandatory to import medical devices depending on
its risk classification from the following dates:
 For Class A and Class B medical devices: 1st October 2022
 For Class C and Class D medical devices: 1st April 2024

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 Classification of Medical Devices
1) Medical devices other than in vitro diagnostic medical devices shall be classified on
the basis of risk (Part I of the First Schedule), in the following classes:
(i) low risk - Class A;
(ii) low moderate risk- Class B;
(iii) moderate high risk- Class C;
(iv) high risk- Class D.

(2) In vitro diagnostic medical devices shall be classified on the basis of risk (Part II of
the First Schedule), in the following classes:—
(i) low risk - Class A;
(ii) low moderate risk- Class B;
(iii) moderate high risk- Class C;
(iv) high risk- Class D.

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 Online Portal of India MDs Regulations
- https://www.cdscomdonline.gov.in/NewMedDev/Homepage
- https://www.nsws.gov.in/
(Form MD-1, Form MD-12, Form MD-16)

• Submission of applications in CTD format

• Generation of Application reference number
• Issuance of query
• Response to Query
• Meeting requests with Indian Regulatory Officers
• Document Lifecycle Plan (DLP) and Submission Lifecycle Plan (SLP)
• Troubleshooting and Support

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 Requisite Documents Checklist
1 Apostilled Power of Attorney
2 The Domestic manufacturer or authorized agent shall submit the duly signed folling information pertaining to
manufacturing site:
3 Constitution details of Domestic manufacturer or authorized agent;
4 Site or plant master file as specified in Appendix I of Fourth Schedule;
5 Device master file as specified in Appendix II for medical devices other than in-vitro diagnostic medical devices, or
Appendix III for in-vitro diagnostic medical device of Fourth Schedule;
6 Notarized Labels and IFU
7 Essential principles checklist for demonstrating conformity to the Essential Principles of safety and performance of
the medical device including in-vitro diagnostic medical device;
8 Undertaking signed stating that the manufacturing site is in compliance with the provisions of the Fifth Schedule/
ISO13485;
9 Notarized copy of overseas manufacturing site or establishment or Plant Registration, whatever name called, in the
country of origin issued by the competent authority and Free Sale Certificate issued by the National Regulatory
Authority or Equivalent competent authority of the country concerned as referred under Rule 36;
10 Notarized copy of Quality Management System Certificate or Full Quality Assurance Certificate or Production
Quality Assurance Certificate issue dby the competent authority in respect of the manufacturing site;
11 Self-attested copy of valid Wholesale License or manufacturing license issued under these Rules;
12 Copy of latest inspection or audit report carried out by Notified bodies or National Regulatory Authority or
Competent Authority within 3 years, if any;
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 Requisite Documents Checklist
Executive Summary Details
Device Description and product specifications, including variants and accessories
The dossier should contain the descriptive information for the device
Product specification
Reference to predicate or previous generations of the device
Labelling
Design and Manufacturing Information
Device Design
Manufacturing processes
Essential Principles Checklist
Risk analysis and control summary
Verification and validation of the medical device
Biocompatibility
Medicinal Substances
Biological Safety
Sterilization
Software verification and validation
Animal Studies
Stability Data
Clinical Evidence
Post Marketing Surveillance Data (Vigilance Reporting)
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 International Regulator Portal
• User Access and Roles Trou • Query Management
Subm • Submission Planning blesh
ootin
• Issue Resolution
ission • Document Preparation
Mana • Document Compilation g and • Training and Support
geme Issue
nt’s Resol
ution
Docu • Version Control Secur
ment
• Data Security
• Document Library ity
Lifecy and • Regulatory Compliance
cle • Lifecycle Tracking Com
Mana plian
geme ce
nt
• Submission Dispatch Repo • Submission Tracking
Dispa
tch • Archival
rting • Analytics
and
and
Analy
Archi
tics
val

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 ASEAN Common Technical Dossier (ACTD)
• Product information
• Quality Data (Include specifications,
manufacturing processes, stability data, and
Preparing the Dossier analytical methods.)
• Nonclinical Data
• Clinical data
• Labelling and Packaging
• Compilation and Organization
• Local Requirements
• Electronic Format (if applicable)
• Submission to Regulatory Authority
Submission Process • Regulatory Review
• Responding to Queries
• Post-Approval Commitments
• Marketing Authorization

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 Dossier for the US, EU, Canada, GCC, Australia,
Switzerland, South Africa, and Thailand

Module 1: Administrative Information: Cover letter, application form, letter of

authorization.
Module 2: Common Technical Document Summaries: Quality, nonclinical, and
clinical overviews.
Module 3: Quality: Information about the drug substance and product quality.
Module 4: Nonclinical Study Reports: Detailed reports of nonclinical studies.
Module 5: Clinical Study Reports: Detailed reports of clinical trials.
Module 6: Overall Conclusions and Post-Approval Commitments: Summarize
and provide post-approval commitments.

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 Dossier Format for the European Region as per
(UDI) code.
vNeeS
UDI requirements: all medical devices will now needFormat
to be assigned a unique device identification

 vNeeS format allows applicants to submit their dossier electronically, but the submission
is not fully compiled into the eCTD structure. Instead, the vNeeS format focuses on
providing non-eCTD electronic submissions in a specific format for certain types of
applications.

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 National Pharmaceutical Pricing Authority (NPPA)
Regulatory body in India that operates under the Ministry of Chemicals and Fertilizers. Its primary role is to
regulate and control the prices of pharmaceutical products to ensure that essential medicines remain
affordable and accessible to the general public.
Step 1: Preparing the Understand Regulatory Requirements
Application Gather Documentation
Step 2: Writing the Application Clinical Trial Protocol
Investigator's Brochure
Informed Consent Form

Step 3: Compilation and Compile the Application

Formatting Formatting

Step 4: Regulatory Submission Submission Form

Cover Letter
Submission Platform

Step 5: Review and Follow-Up Review Submission

Confirmation of Receipt
Step 6: Regulatory Review Review Process
Clarifications
Step 7: Approval and Initiation Approval
Initiate the Trial
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 Questainnaire

1. What is the purpose of a Design Dossier in the regulatory

submission process?

a. Market analysis
b. Risk assessment
c. Compliance with design standards
d. All of the above

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 Questainnaire

2. What is the primary focus of a Clinical Evaluation Report (CER)?

a. Technical performance
b. Safety and performance based on clinical data
c. Marketing strategy
d. Manufacturing process

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 Questainnaire

3. What does the Declaration of Conformity (DoC) signify in the

regulatory context?

a. Approval for market authorization

b. Manufacturer's compliance statement
c. Clinical evaluation report
d. Product labeling requirements

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 Questainnaire

4. What is the primary function of the SUGAM portal?

a. Submission Dispatch
b. Query Escalation
c. DLP Management
d. Archival of Documents

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 Questainnaire

5. What is the primary focus of the ACTD format?

a. European region
b. ASEAN countries
c. US and Canada
d. GCC and Australia

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Intellectual Property Rights for
Medical Devices and In-vitro
Diagnostic Devices

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 Intellectual Property – MDs and IVDs
 Intellectual property (IP) refers to creations of the mind, such as inventions; literary and artistic works;
designs; and symbols, names and images used in commerce.

 For example, patents, copyright and trademarks, which enable people to earn recognition or financial
benefit from what they invent or create.

Types of Intellectual Property for Medical Devices:

1. Trademark Protection: Trademark protects distinct words, symbols, design, representation, or combination of any
one of them together and which can represent the goods or services of one brand from another’s.
2. Patent: If an invention is novel, includes an inventive step or is not obvious and is capable of industrial application,
it is eligible to receive protection under Patent Law. The rights granted under a Patent are valid for up to a period of
20 years.
3. Design Patent: It provides protection to the design of the medical device. It grants the patent holder monopoly
over the design and does not allow anyone else to commercialise it or a design similar or identical to the patent
owner’s design unless without the consent of the patent holder or through a license.

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 Intellectual Property – MDs and IVDs

Types of Intellectual Property for Medical Devices:

4. Trade Dress Protection: It refers to the whole look and feel of the medical device. For
it receive protection, a trade dress must have identifiable characteristics. It shall include
the shape, size, colour, and colour combinations which are aligned with the identity of
the product.

5. Trade Secret Protection: It shall include business plans, source code, marketing
strategies, customer lists and process related inventions. These require protection as
these help product achieve distinctiveness and success in the market.

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 Search Strategies
Understanding the invention, creating effective search strategies, and executing those
strategies are essential steps in conducting a patent search. This has to be done properly to
assess an invention’s novelty and potential patentability.

Initial Creating Search Strategies Executing Search Strategies

Understanding Identify Keywords and Synonyms Online Patent Databases
of the Invention Classifications and Categories Patent Search Tools
Identify Key Concepts Refinement and Iteration
Analyze Results

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 Data Collection on Products, Probable Customers and Competitors
 gathering relevant information from various sources to gain insights into the market
landscape and make informed decisions.
Application
Programming Secondary Sources (IMS,
Intellectual Property Scifinder, Newport, IPD
Interfaces (API) (IP) Databases Analytics)
Marketing Team

Data collection from the API Marketing team, IP databases, and secondary
sources like IMS, Scifinder, Newport, and IPD Analytics involves extracting
relevant information about products, customers, and competitors. This data is
then analyzed to make informed marketing decisions, develop effective
strategies, and stay competitive in the market.

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 Research, Marketing, and Data Analysis

Extracting and Evaluating Search Results: performing searches on relevant platforms or databases (like
mentioned earlier) using specific keywords, filters, and criteria

Culling: review the collected search results to remove duplicates, irrelevant or

redundant information, and low-quality data

Report Formation: Organize the remaining search results into a structured report format. This report
could be in a document, a spreadsheet, or a presentation.
Grouping the information based on categories such as products, customers, competitors, or other relevant
factors.

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 Research, Marketing, and Data Analysis
Mapping and Result Evaluation: create a visual or conceptual map of the collected data to identify
relationships, trends, and patterns. This could involve using mind maps, concept maps, or diagrams.
Evaluate the mapped data to draw insights. Look for connections between different pieces of information
and analyze how they relate to your research goals.

Rejection Summary: Document and summarize the reasons for rejecting certain search results during the
culling process.
Provide a clear rationale for excluding specific data points or information to maintain transparency and
ensure the integrity of the analysis.

Visualization through Charts: Select appropriate chart types (e.g., bar charts, line charts, pie charts)
based on the nature of the data and the insights associates want to convey.
Input the relevant data into a data visualization tool or software. Create visualizations that effectively
represent the data's relationships, comparisons, and trends.

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 Research, Marketing, and Data Analysis

Result Evaluation and Interpretation: Analyze the mapped data, report, and visualizations to draw
meaningful conclusions

Reiteration and Refinement: Depending on the quality of insights and feedback, associates might need to
refine their search queries, culling criteria, or visualization approaches.

Communication and Presentation: Prepare a comprehensive report or presentation with organized

data, visualizations, insights, and actionable recommendations.
Communicate the findings to stakeholders or decision-makers, ensuring that the information is easy to
understand and supports informed decision-making.

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Maintaining Correct Reports

Define Report Requirements Review and Quality Assurance

Design the Report Format Update and Maintenance

Establish Naming Conventions

Data validation and report versioning

Data Collection and Compilation Accessibility and Distribution

Documentation and Guidelines and
Report creation continuous improvement

N.S.D.C
Preparation of Patent Landscape Report for Medical / In-vitro Diagnostic Devices

Patent landscape reports provide a snapshot of the patent situation of a specific technology, either within a given
country or region, or globally.

- Define the Scope and Objectives - Interpretation and Recommendations

- Identify Relevant Keywords and Concepts - Executive Summary and Conclusion
- Conduct Patent Searches - Presentation and Communication
- Data Collection and Filtering - Periodic Updates
- Patent Document Analysis
- Technology Classification
- Competitive Analysis
- Technology Trends and Innovation Pathways
- White Space Analysis
- Visualization and Reporting
- Report Compilation

N.S.D.C
 Drafting of In-house Opinion Reports for the Invalidation of Patents

 involves conducting a thorough analysis of a granted patent to identify potential

weaknesses or grounds for invalidation. These reports are valuable tools for making
informed decisions regarding challenging or invalidating a patent.
 requires a combination of legal expertise, technical understanding, and careful
analysis. These reports play a critical role in making informed decisions about
challenging the validity of a patent and navigating the complex landscape of
intellectual property.

N.S.D.C
Drafting a Provisional Patent Application Drafting a Non-provisional Patent Application
 formal application that, when granted, leads to
an issued patent. It includes detailed
 serves as an initial placeholder and information about the invention and goes
establishes an early filing date. It through examination by the patent office.
 Steps:
provides associates with a year to
• Invention Description
further develop the invention before • Claims
filing a non-provisional application. • Drawings
 Steps: • Abstract
• Invention Description • Background and Field of the Invention
• Specifications • Detailed Description
• Claims • Exemplary Embodiments
• Drawings • Formal Requirements
• Filing • Review and Proofreading
• Filing
• Response to Office Actions

N.S.D.C
 Collecting Information on Products, Probable Customers and Competitors
 Collecting relevant information on products, potential customers, and competitors from various sources like
the API Marketing team, IP databases, and secondary sources (such as IMS, SciFinder, Newport, and IPD
Analytics) involves a systematic approach to ensuring accurate and comprehensive data collection.

 Define Information Needs

 Collaborate with API Marketing Team
 Utilize IP Databases
 Access Secondary Sources
 Information Collection:
Products:
• Collect product details, including specifications, features, uses, and benefits.
• Obtain information about product variations, packaging, and unique selling points.
Probable Customers:
• Identify the target customer segments for the products. Gather data on demographics, preferences,
and purchasing behavior.
• Obtain insights into customer needs, pain points, and potential adoption barriers.
Competitors:
• Compile a list of key competitors in the industry. Gather information about their products, market
share, strengths, and weaknesses.
• Analyze competitors' patent portfolios, trademarks, and any ongoing litigation.
N.S.D.C
 Collecting Information on Products, Probable Customers and Competitors

 Data Validation
 Data Organization
 Data Analysis
 Report Generation
 Present Findings
 Continuous Monitoring

This demonstration allows associates to gather valuable insights to inform

strategic decisions, product development, and competitive positioning.

N.S.D.C
 Prior Art Search /Patentability
Search
 step to determine the novelty and potential
patentability of an invention.
 Step 1: Define the Scope
 Step 2: Identify Keywords and Synonyms
 Step 3: Select Patent Databases
 Step 4: Search Strategy
 Step 5: Review Search Results
 Step 6: Analyze Patent Documents
 Step 7: Search with Classification Codes
 Step 8: Review and Refine
 Step 9: Legal Status and Citations
 Step 10: Analysis and Comparison
 Step 11: Evaluate Novelty and Obviousness
 Step 12: Document Findings
 Step 13: Consult with Experts
 Step 14: Make an Informed Decision

N.S.D.C
 Drafting and Completing Patent Application

1. Title: Choose a descriptive title that accurately reflects the invention.

2. Cross-Reference to Related Applications: If applicable, include references to any related
provisional applications or previously filed non-provisional applications.
3. Background of the Invention: Provide context by explaining the technical field and the problem
your invention aims to solve.
4. Summary of the Invention: Provide a concise overview of the invention's key features,
components, and advantages.
5. Detailed Description: Describe the invention, including its structure, operation, and
functionality. Use clear and precise language.
6. Drawings: Include detailed and labeled drawings that help illustrate the invention. Use different
views if necessary.
7. Claims: Draft the patent claims defining the scope of protection sought. Claims should be clear,
specific, and supported by the description.
8. Abstract: Summarize the invention in a brief abstract that captures its essence.
9. Inventorship: List the names of all inventors involved in creating the invention.

N.S.D.C
Drafting and Completing Patent Application

10. Filing Information: Include relevant filing details, such as the inventors' addresses,
application type (provisional, non-provisional), and other required information.
11. Declaration and Power of Attorney: Include a declaration or oath signed by the
inventor confirming the authenticity of the application. A power of attorney may also be
required.
12. Drawings: Include detailed and labelled drawings that help illustrate the invention. Use
different views if necessary.
13. Fees: Pay the required filing fees associated with the application.
14. Formal Requirements: Ensure that your application meets the patent office's formal
requirements, including formatting, page limits, and document naming conventions.
15. Review and Proofreading: Thoroughly review the application for accuracy, consistency,
and compliance with patent office guidelines.

N.S.D.C
 Questainnaire

• What is the primary purpose of a patent landscape report?

a. Legal enforcement
b. Identifying competitors
c. Marketing strategy
d. Financial analysis

N.S.D.C
 Questainnaire

• In patent application drafting, what is the key difference between

provisional and non-provisional applications?

a. Duration of protection
b. Filing fees
c. Level of detail required
d. Applicability to medical devices

N.S.D.C
 Questainnaire

• What is the role of culling in the search results process?

a. Adding irrelevant information

b. Removing irrelevant information
c. Evaluating patent validity
d. Drafting patent applications

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 Questainnaire

• When is an in-house opinion report typically drafted?

a. Before filing a patent application

b. After patent grant
c. During product development
d. In response to legal challenges

N.S.D.C
Thank you

N.S.D.C