Medical Devices are now regulated in India. It is essential to know about the Medical Devices Regulations and how it is being implemented. Must know for all the manufacturers, importers and Distributors of Medical Devices.

1. Medical Devices, E-Health
Solutions, Indian Medical
Devices Rules and Regulatory
Aspects-IIHMR- Day3
Dr S.B.Sinha,
EX-President
Biomedical Engineering
Society of India

2. Health care products
Classification
• Defined as anything used for Prevention,
Diagnosis and treatment of diseases in
human beings or animals.
• Medicines or Drugs.
• Medical Devices- Equipment, Furnitures and
consumables

3. Medical Devices- Definitions
● As per WHO ‘Medical device’ means any instrument, apparatus,
implement, machine, appliance, implant, reagent for in vitro use,
software, material or other similar or related article...
● Medical equipment is used for the specific purposes of diagnosis and
treatment of disease or rehabilitation following disease or injury; it can
be used either alone or in combination with any accessory, consumable
or other piece of medical equipment.
● in vitro diagnostic device (IVD) A medical device is an in vitro
diagnostic medical device (IVD) if it is a reagent, calibrator, control
material, kit, specimen receptacle, software, instrument, apparatus,
equipment or system, whether used alone or in combination with other
diagnostic goods for in vitro use

4. In Vivo and In Vitro Difference
In vivo is Latin for “within the living.” It refers to work that’s performed in a whole, living
organism. When a study is performed in vivo, it can include things like performing experiments in
an animal model, or in a clinical trial in the case of humans. In this case, the work is taking place
inside a living organism.
In vitro is Latin for “within the glass.” When something is performed in vitro, it happens outside
of a living organism. In vitro methods used in a laboratory can often include things like studying
bacterial, animal, or human cells in culture. Although this can provide a controlled environment
for an experiment, it occurs outside of a living organism and results must be considered carefully.

5. Medical Devices-
Definitions
• Prosthetic devices are
artificial body parts such as
eyes, heart valves, arteries or
limbs.
• Medical Devices is a wide
spectrum of Medical
Equipment, Prosthetic
Devices, IVD(In Vitro Devices)
and others.

6. Medical Devices- Examples
• Medical Equipment examples are CT Scanner, MRI, ECG
Machine.
• Prosthetic Devices are- Ocular lenses, Artificial Hip,
Artificial legs, Spectacles, Heart Valves etc.
• Prosthetic devices which can be implanted are also known
as implantable devices eg Knee Implant, Hip Implant etc.
• IVD Examples are- Blood Gas Analyser, Bio Chemistry
Analyser, Reagents, Test Tubes, Pregnency Test Kit,
Glucometer , software being used etc.

7. E-Health
● E-Health has been broadly defined as health care delivery by
convergence of internet and healthcare devices.
● The following are the elements of e-health:
○ Telemedicine-
○ EHR- Electronic Health Record.
○ M-Health
○ Evidence based medicine.

8. E-Health

9. E-Health
benefits
E-Healthcare is used to improve the following:
Access
Efficacy
Effectiveness
Quality of treatment
Business processes.
•Is used by healthcare organizations, patients, doctors,
nurses and other stake holders utilizing advanced softwares
and artificial intelligence for treatment, education,
surveillance and research.

10. ● Telemedicine System

11. ReMeDi Solutions
• Indigenously developed
and patented technology
telemedicine solution
• Multiparameter Remote
Diagnostics Kit.

12. WHO Technical Evaluation Report
• Cater to remote telemedicine in low resource set ups. The technology enables
rural patients to reach urban doctors through a telemedicine solution that
integrates the whole healthcare delivery ecosystem to provide meaningful
services. The solution also captures the workflow of delivery processes, and
enables resource optimization by capturing and analysing operational data in
service delivery.
• The technology comprises of a USB powered multiparameter diagnostic
device which captures ECG, temperature, heart & lung sounds, SPO2 and BP,
and communicates with the remote doctor through a low bandwidth
audio/video/data conferencing.

13. WHO Technical Evaluation Report
• Operating steps- A rural operator carries out remote consultation for the patient
at the village with a doctor sitting anywhere with aninternet connection. The
doctor remotely controls the device to obtain medical parameters, and to provide
prescription to the patient, while medical records are stored. The solution also
supports supply-chain, lab reports, and referrals.
• User and environment User: Self-use/patient, physician, technician, nurse,
midwife, family Training: On-site individual/group training,
videoconferencing/teamviewer based e-training, 2-4 hrs Maintenance: Annual,
Preventive. To be conducted by Manufacturer.
• Neurosynaptic Communications Pvt Ltd- Banagalore

15. M-Health Disease Management
Scopes
• Health Risk Assessments-
• Patient support dedicated groups.
• Online discussion forums.
• Moderated chats with guest experts.
• Comprehensive patient education.
• Ask an expert panel for patient safety medical
advice.
• Electronic newsletter subscription.

16. TEA BREAK
11.15 PM
WE WILL MEET AT 11.30
PM

17. EHR- Electronic Health Record
● An Electronic Health Record:
● Is a secure and private lifetime record of an individual health
and care history.
● Is available electronically to authorised healthcare providers.
● Facilitates sharing of data across continuum of care across
healthcare delivery organisations and across geographical
boundaries.
● Should comply to EHR standard of MoHFW in India

18. Examples of e-health
DocsApp- Is a private App based
service where tele consultation
can be made with a selected
expert. The expert provides
consultation as well as prescribes
medications based on the
interactions with the patients.
CSC- Common Service Centre has
collaborated with Apollo
Telehealth and is delivering
healthcare services to remote
areas.
Odisha, Maharashtra and Punjab
has established telemedicine
network.
National Cancer Grid, TATA
Memorial Hospital and Kavya are
leading evidence based cancer
treatments .
NHM has set up National Rural
Telemedicine Network to deliver
healthcare by telemedicine in
remote areas.

19. Examples of e-health
• MoHFW has launched Teleradiology Services and 10 states are
reporting X-Rays by digitizing the X-Rays and transmitting the same to
Teleradiology Centre in PPP Mode.
• 1 National Resource Centre at SGPGI Lucknow and 07 Regional
Resource Centre have been set up to provide telemedicine services to
connect 500 PHC/CHC/SC to 50 District Hospitals,
• M-Health is also being provided by Apple Watch and Fitbit smart
watches.

20. The opportunity in Healthcare

21. Market Size Healthcare- India

22. Some facts Indian Healthcare

23. Health Insurance Premiums

24. Facts about Indian Healthcare
• Fourth largest Employer- Expected to generate 40 million jobs by
2020.
• Impressive growth- At CAGR of 22% during FY 16-22 to reach USD
372 billions in 2022 from USD 110 billions in 2016
• Strong fundamentals and cost advantage- Rising income levels,
growing health awareness and changing attitudes towards preventive
healthcare to boost healthcare demands in future and low cost of
services to boost medical tourism.
• Favourable investment climate- 100% FDI , tax benefits and
favourable govt policies with growth prospects have attracted private
equity, venture capitals and foreign players.

25. Medical Device Regulations-Why
• There will be chaos if we don’t follow the Rules

26. Going will
be smooth if
we follow
the RULES

28. How are the health care products regulated
The following are regulatory bodies in India:
1. CDSCO-Central Drugs Standard Control Organization (CDSCO), Ministry
of Health & Family Welfare, Government of India provides general
information about drug regulatory requirements in India and regulates
them. At central level it is headed by DGCI(Drug Controller General of
India) and regulates import of all MD, manufacturing of Class C&D
Devices, and clinical investigations of all MD while at State Drug
Controllers regulate the manufacturing of Class A&B devices.
2. NPPA-National Pharmaceutical Pricing Authority- NPPA is independent
body under Department of Pharmaceuticals, Ministry of Chemicals and
Fertilizers. It regulates MRP

29. How are the health care products regulated
CDSCO - Central Drugs Standards Control Organisation- is the main body
under Ministry of Health and Family Welfare regulates the Drugs as well as
Medical Devices.
Regulated under Drugs and Cosmetic Act- 1945
Drugs are regulated under Drugs and Cosmetic Rules-1945
Medical Devices and In Vitro Medical Devices are regulated under Medical
Devices Rules 2018

30. LUNCH BREAK 1.00
PM
WE WILL MEET AT 2.00 PM

31. The regulatory reforms-
1. Drugs are regulated under Drugs and Cosmetic Act 1945. -CDSCO
regulates the introduction of new drugs (DGCI) and import of Drugs and
State Authorities AND Central Authorities jointly regulate the
manufacturing of the drugs under Drugs and Cosmetic Rules 1945.
2. Medical Devices were not regulated until 2017. To regulate the Medical
Devices Medical Devices Rules are now in force from 2018.

32. Regulatory reforms- How it progressed
1. Drugs were regulated under Drugs and Cosmetic Act 1940 and Drugs
and Cosmetic Rules 1945. The regulators are Drug Controller General of
India at the central level and State Licensing Authorities in the States.
This deals with the introduction of new drugs, import of drugs and
manufacturing licences of Drugs. No regulation in pricing was in force
under this Act.
2. DPCO-Drug Pricing Control Order introduced first in 1995 enables GoI to
regulate the pricing of Essential and Life saving drugs under powers in
Essential Commodities Act of 1955.
3. National List of Essential Medicines was introduced in 2011(NLEM 2011)
and this serves as the list of medicines that comes under price control.

33. Regulatory reforms -How it progressed
4. The DPCO-2013- Includes all the Drugs specified in NLEM 2011.
5. National Pharmaceuticals Pricing Policy was framed by Department of
Pharmaceuticals under Ministry of Chemicals and Fertilisers in 2012 to
regulate the pricing of Drugs.
6. National Pharmaceutical Pricing Authority (NPPA) has been created to look
after monitoring and implementation of pricing of Drugs.
7. DPCO-1995 is cost based pricing and DPCO-2013 is Market Based Pricing
(MBP) and is the average of all the medicines with market of >1% and 16%
trade margin is added for retailers.

34. Regulatory reforms-How it progressed
1. The Drugs are now well regulated in terms of introduction,
manufacturing and selling with MRP Capped by DPCO 2013. The Medical
Devices were not regulated till 2018. The Medical Devices Rules
2017(MDR-2017) under Drugs and Cosmetic Act has been enforced
effective 2018.
2. The Medical Device Rules requires the notified devices to be regulated
under the MDR 2017. The new Rules have been framed in conformity
with Global Harmonisation Task Force (GHTF) framework and conform
to best international practices.
3. The MD are classified as Low Risk-Class-A, Low Moderate Risk- Class-B,
Moderate High Risk-Class C and High Risk-Class-D

35. Objectives of MD Rules
• To provide safe and quality MD to the patients.
• To provide competitive environment to the
manufacturers to enable growth of MD industry.
• To import safe and quality MD.
• To provide risk based regulation of the MD.
• To provide post marketing Adverse Event Reporting of
medical devices.
• To incorporate a recall system of MD based on post
market surveys.

36. ● Medical Devices Market

37. MD
Market
key facts
• 4th Largest market in Asia after Japan, China
and South Korea.
• App 750-800 manufacturers.
• Growing from 2.02 billion USD in 2009 to 3.9
billion USD in 2015 it is estimated to grow at
CAGR of 16 % to 50 billion USD by 2025.
• Presently valued at 4-5% of the total
healthcare market in India.

38. Medical Devices Rules, 2017
• Medical Device rules are effective from 01.01.2018, under the
Drugs and Cosmetics Act 1940 -
• To regulate the Clinical Investigation, Manufacture, Import, Sale
and Distribution of the medical devices in the country.
• The Medical Devices Rules, 2017 are harmonised with the
international regulatory practices and provide comprehensive
legislation for the regulation of Medical Devices, which will
foster Make in India also.

39. Scope of the regulation
Medical Device Rules,2017 shall be applicable to:
(i)substances used for in vitro diagnosis and surgical dressings, surgical bandages,
surgical staples, surgical sutures, ligatures, blood and blood component collection bag
with or without anticoagulant covered under sub-clause (i) of section 3 of the Drugs
and Cosmetics Act, 1940 (23 of 1940);
(ii)substances including mechanical contraceptives (condoms, intrauterine devices,
tubal rings), disinfectants and insecticides notified under sub-clause (ii) of section 3 of
the Drugs and Cosmetics Act, 1940 (23 of 1940); and
(i) devices notified from time to time under sub-clause (iv),
of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940);

41. 41
The Govt of India has notified…
S. No Name of the device Earlier to
jan 2018
SLA/CLAA
Date of notification
1 Disposable Hypodermic Syringes SLA 17-03-1989
2 Disposable Hypodermic Needles SLA 17-03-1989
3 Disposable Perfusion Sets SLA 17-03-1989
4 In vitro Diagnostic Devices for HIV, HbsAg and HCV and
blood grouping sera
SLA 27-08-2002
5 Cardiac Stents CLAA 06-10-2005
6 Drug Eluting Stents CLAA 06-10-2005
7 Catheters CLAA 06-10-2005
8 Intra Ocular Lenses CLAA 06-10-2005
9 I.V. Cannulae CLAA 06-10-2005
10 Bone Cements CLAA 06-10-2005
11 Heart Valves CLAA 06-10-2005
12 Scalp Vein Set CLAA 06-10-2005
13 Orthopedic Implants CLAA 06-10-2005
14 Internal Prosthetic Replacements CLAA 06-10-2005
15 Ablation Devices *CLAA 25-01-2016

42. Following products are notified as ‘drugs’ but under MDR-
2017 regulated as Medical Devices
• Sutures and Ligatures
• Disinfectants
• Blood Grouping Sera
• Surgical Dressing
• Umbilical Tapes
• Condoms
• Intra Uterine Devices
• Vaginal Tubal Rings
• Blood Bags

43. Salient features of MD Rules
• Risk based classification of MD
• Single window online applications and time bound clearances.
• Deemed approval if not cleared within timelines.
• Provision of notified body.
• QMS in line with ISO 13485 adopted.
• Perpetual licensing- renewal fees every five years.

44. • Medical devices shall be notified by the Central Government
and classified by the CLA based on the classification rules
specified in the First Schedule of the drafted rules.
• Following are the risk Classes and the classification criteria
based on the severity of risk associated with the medical
device.
Risk Criteria Risk Class
Low Class A
Low-Moderate Class B
Moderate-High Class C
High Class D
Risk based classification……...…….

45. Devices Risk Class
Nasopharyngeal Catheters, Y Connectors
for perfusion sets etc.
Class A
Cell separators, BP Monitoring Devices,
Digital Thermometers
Class B
CT Scanners ,MRI, Defibrilators, X-Ray,
Nebulisers, Organ Preserving solutions,
Cardiac Stents, Knee implants
Class C
Hip implants, Angiography catheters,
Cochler implants, Hip joint implants
Class D
Risk based classification--Examples

46. TEA BREAK 3.15 PM
WE WILL MEET AT 3.30 PM

47. Chapter- I Title, Application, Commencement, Definition
Chapter - II Classification of MD, Grouping of MD, Essentials Principles
Chapter - III Authorities, delegation of powers, Notified bodies, Medical Devices Testing
Centres,
Chapter - IV Manufacture of MD-Application, Inspection, grant of lic, conditions of lic,
Suspension, Cancellation, Appeal, Test License
Chapter - V Import of MD-Application, Overseas Inspection, grant of lic, Test lic, Hospital use,
Personal use
Chapter - VI Labelling requirement
Chapter - VII Clinical Investigation- Permission, Medical management, Compensation,
Inspection
Chapter - VIII Permission to import or manufacture medical device which does not have
predicate medical device
Chapter -IX Duties and Powers of Medical Device Officer, Medical Device Testing Officer and
Notified Body
Chapter -X Regulation of Laboratories for carrying test or evaluation
Chapter - XI Sale of Medical Devices
Chapter - XII Miscellaneous – Rejection of application, Debarment of applicant, Exemptions
Medical Device Rules,2017 Chapters

48. Schedule Number Title
First Classification of MD and IVD
Second Fee
Third Registration and functions of Notified Bodies
Fourth Documents required for grant of mfg and Import licence
Fifth Quality Management System
Sixth Post Approval - Major and Minor Changes
Seventh Requirements to conduct Clinical Investigation
Eight Exemptions
Medical Device Rules, 2017-Schedules

49. Scope of Notified Bodies
 Only Class A and Class B medical Devices
 To verify QMS conformance at manufacturing site where necessary by
inspection
 Verification of Essential Requirements
 Verifying validation of manufacturing process through objective
evidence
 conformity of material with defined specifications
 Responsibility for ensuring conformance to QMS and conditions of
license/registration

50. Manufacture of
medical Device
for Sale or
Distribution-
Class A&B MD
Manufacturer shall apply through an identified
online portal of Ministry with requisite documents
as per Fourth schedule and fees specified in
Second schedule.
No audit for class A device prior to grant of
license. The audit may be carried out within 120
days from the date of issue of license
The audit for Class B device is necessary prior to
the grant of manufacturing license and the audit
shall be carried out within 90 days from the date
of application
The notified body shall furnish its report to SLA
within 30 days

51. Manufacture of
medical Device
for Sale or
Distribution-
Class C&D MD
The application shall be made with requisite
documents and fees through online portal of
the Central Government to CLA.
CLA may use the services of any expert and of a
notified body and may carry out an inspection
within a period of 60 days from the date of
application.
No inspection of a medical device
manufacturing site for grant of loan license to
be carried out if the site is already licensed to
manufacture such devices.
After completion of inspection , the inspection
team shall forward the report to CLA through
online portal.

52. Import of MD
• Appoint an authorised agent having IEC Code.
• Apply in Form MD-15 for import of Notified MD
and in form MD-29 for notified MD for clinical
investigation and Form MD-29 for new MD for
Clinical investigation.
• It takes 9 months for getting the import license
of Notified MD and 30 days for devices
requiring clinical investigation.
• Apply in form MD-27 for a MD that donot have
a predicate devices. Takes 120 days for import
license.

53. Standards of
medical
Devices
• The medical device shall conform to the
standards laid down by BIS or may be notified
by Central Government from time to time. If,
such standards are not available then ISO, IEC
or any other pharmacopoeial standard. If all
are nor available then device shall conform to
the validated manufacturers standard

54. Regulatory Authorities
Device Class
Activity
Class A Class B Class C Class D
IMPORT CLA CLA CLA CLA
MANUFACTURE SLA SLA CLA CLA
Permission to
conduct CI
Permission from CLA
SALE SLA
QMS Verification
by
*Notified
Body
*Notified Body CLA CLA
*Note: Notified Bodies shall be registered with Central Licencing Authority. Prior
inspection shall not be required before the grant of manufacturing of Class
A devices.

55. Medical Device Clusters in India

56. Regulatory Landscape:
Government
Support & Initiatives
for
Medical Devices Sector

57. Status of Implementation of MDR, 2017
• New Medical Device Online portal is functional
for uploading the applications for Import License
and Manufacturing License of Medical devices
and IVDs, for post approval changes, registration
of medical devices testing laboratories , clinical
investigation etc. https://cdscomdonline.gov.in/
•Classification of Medical Devices and IVDs has
been finalized in consultation with the
stakeholders and uploaded in the CDSCO
website. This is dynamic process.

58. Status of Implementation of MDR, 2017
• Medical device online portal is functional for the registration of Notified Bodies.
Four notified bodies have been registered and information is available on the
CDSCO website.
• Grouping of Medical Devices and IVDs along with essential principle checklist has
been finalized in consultation with the stakeholders and uploaded in the CDSCO
website.
• Notification of Medical Device Officer and Medical Device Testing Laboratories
have been published.

59. Status of Implementation of MDR, 2017
• CDSCO organised workshops to impart trainings to State Licensing Authorities i.e.
Delhi, Rajasthan and stakeholders for the effective implementation of Medical
Devices Rules, 2017.
• For addressing various questions on regulatory practices in medical devices,
Frequently Asked Questions (FAQ) on medical devices and in vitro diagnostics is
uploaded on CDSCO website. Also regular interactions are taking place with all
the stakeholders to resolve their regulatory practices issues.
• Guidance on Performance Evaluation of In-vitro Diagnostic Medical Devices have
been published on the website.
• Public relation office is established by CDSCO to guide the start-ups and
innovators.

60. Status of
Implementation
of MDR, 2017
16 Technical Committees of BIS are framing the
standards of
Medical devices and IVDs.
Compilation of Rules/Standards/FAQs by IPC.
5 officials from India are trained on Medical
Device Regulation at
PMDA academy.

61. Status of Implementation of MDR, 2017
Launch of Support Cells for WHO PQS for IVDs in India
• For providing guidance to the Indian manufacturers for the WHO Prequalification
of In Vitro Diagnostics Programme in India
1) National Institute of Biologicals in North India
2) Andhra Med-tech Zone in south India

62. Status of MDR Implementation
Medical Devices Rules
2017 were introduced in
2017 AND are required to
be complied with effective
Jan 2018.
List of Regulated Devices
were released in pieces
However the regulators
defined the MD and all
the Medical Devices were
required to comply with
the regulations in phases.
Phase-1- All the MD are
required to be registered
with CDSCO till 1st Oct
2021. This has been
extended till 1st May 2022
Phase-2- All the Devices in
Class A and B are required
to get Manufacturing or
Import License till 1st Oct
2022
Phase-3- All the Devices in
Class C & D are required
to get Manufacturing OR
Import License till 1st Oct
2023.

63. Status of Medical Devices Implementation
37 Devices have been notified
as below out of which 15 are
Medical Equipment as shown
in the table
These devices can no longer
be sold or imported or
manufactured without
registration

64. Launch of WHO Collaborating Centre for Pharmacovigilance in
Public Health Programmes and Regulatory Services
at
National Coordination Centre- Pharmacovigilance Programme of
India, Indian Pharmacopoeia Commission, Ministry of Health and
Family Welfare, Government of India

65. Materiovigilance
Programme is
initiated under
PvPI for Adverse
Event Reporting
of MD
National Coordination Centre (IPC, Ghaziabad).
National Collaboration Centre ( Sree Chitra
Tirunal Institute
of Medical Sciences and Technology,
Tiruvananthapuram).
Technical Support and Research Centre
(National Health
System Resource Centre- NHSRC).

66. THANKS
• THANKS FOR LISTENING