Medical Device Regulation

1. Presented By-
Omkar S. Chothe
M.Pharm First Year
Drug Regulatory Affairs
Medical Device Regulations In
United States, European Union And India
POONA COLLEGE OF PHARMACY
Bharati Vidyapeeth Deemed To Be University
Erandwane Pune-411038 1

2. Content-
1. Introduction.
2. Classification of Medical Device.
3. Phases of Medical Device.
4. Medical Device Regulation in US (U.S.FDA).
5. Medical Device Regulation In European Union.
6. Medical Device Regulation In India (CDSCO).
7. Summary.
8. Reference.
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3. 1.Introduction
Used in the prevention, diagnosis or treatment of illness or
disease, or for detecting, measuring, restoring, correcting or
modifying the structure or function of the body for some health
purpose.
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Article Instrument
Apparatus Machine

4. 2. Classification Of Medical Devices-
Class I –
Low risks for human use.
• Medical device has sufficient information to provide
reasonable assurance of the safety and effectiveness of the
device.
• Medical device is not to be for a use in supporting or
sustaining human life, and does not present a potential
unreasonable risk of illness or injury.
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5. Class II –
Moderate risks for human use.
• Medical device has insufficient information to provide
reasonable assurance of the safety and effectiveness of the
device.
• Medical device cannot be classified as a class I device because
the controls authorized are insufficient to provide reasonable
assurance of the safety and effectiveness of the device.
Class III –
• Premarket Approval for devices considered as High risks for
human use.
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6. 3. Major phases in the life span of a medical device
Manufacturer -Conception & Development
-Manufacture
- Packaging & Labelling
-Advertising
-Sale
-Use
-Disposal
User
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Vendor

7. 45%
30%
10%
15%
Market Share Of Medical Device Industry
USA
EU
Japan
Others
-National Marrow Donor Program(NMDP), 2015
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8. 4. Medical Device Regulation in
United States
Class-1 (Low)
elastic bandages, examination
gloves, hand-held surgical
instruments
Class-2 (Medium)
powered wheelchairs,
infusion pumps, surgical
cloths
Class-3 (Highest)
heart valves, Metal-on-metal
hip joint
U.S. FDA
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Risk to the patient

9. .
The US FDA medical device approval process-
• Step 1
Determine the classification of your device according to the standard FDA classification.
• Step 2
Class I devices have to comply with the QSR (GMPs), except for Part 820.
Class II and 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.
• Step 4
If clinical studies will be 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.
U.S. FDA
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10. U.S. FDA
• Step 6
For Class III devices, FDA conducts facility inspections of all major suppliers involved in
the design and production of your device.
All parties must be compliant 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 21 CFR 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.
Authorization does not expire as long as no changes are made to the device design,
intended use, etc.
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11. European Union (EU)
5. Medical Device Regulation in
European Union (EU)
In the European Union is almost similar to that of the US FDA system.
Class I
devices are those with minimal risk of harm.
Class II a
devices are those deemed relatively low risk to humans.
Class II b
devices pose a relatively high risk of harm to the human body.
Class III
devices are deemed the highest risk of harm to patients and endanger the
patient’s life.
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12. European Union (EU)
Regulatory Process for Medical devices in European Union-
Step1-
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.
Step 3 -
For all devices except 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).
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13. European Union (EU)
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 AR Rep should be qualified to handle regulatory issues.
Step 6 –
For all devices except Class I,
QMS and Technical File must be audited by a Notified Body
Step 7 –
For all devices except 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.
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14. European Union (EU)
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 –
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 Marking certificate. CER must
perform updates and PMS activities.
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15. Central Drug Standards Control Organization (CDSCO)
6. Medical Device Regulation in INDIA
Classification Of Medical Devices-
Class A Low Risk
Class B Low-moderate Risk
Class C Moderate-high risk
Class D High
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16. Central Drug Standards Control Organization (CDSCO)
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 form 40.
Device manufacturers new to India require form 45 in the support of the form
40 Application
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17. Central Drug Standards Control Organization (CDSCO)
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.
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18. Central Drug Standards Control Organization (CDSCO)
India’s new medical device regulations:
• The Medical Device Rules, 2017 came into force with effect on January 1st,
2018 and will be applicable to medical devices and in-vitro diagnostic
medical devices.
• The application for a license to manufacture for sale or for distribution for
medical devices of any class can be found, completed, and submitted on the
Ministry of Health and Family Welfare’s online portal.
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19. 7. Summary
• The regulation of Medical Devices in US, Europe, India are different, But in
these countries pre-market process & post market process is carried out for the
marketing of quality products. In US, the 510(k) process is carried out by the
90% of the manufacturer.
• Clinical studies are strictly required for High-risk devices.
• But in EU more research activities takes place in Medical Device Sector than in
US and India, the growth is expected more than US and India in future.
• In India the government is expected to develop a regulatory structure leading
to quality products being developed by manufacturers.
• The current regulatory structure lacks active participation from the
government, Global Harmonization Task Force (GHTF) guidelines can be
adopted to improve the sector and focus has to make on clinical studies.
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20. 20
8. Reference
1. https://ec.europa.eu/growth/sectors/medical-devices
(A) https://eur-lex.europa.eu/legal-content/EN/TXT/
(B) Council Directive 90/385/EEC on Active Implantable Medical
Devices (AIMDD) (1990)
(C) Council Directive 93/42/EEC on Medical Devices (MDD)
(1993)
Council Directive 98/79/EC on in vitro Diagnostic Medical
Devices (IVDMD) (1998)
2. https://www.fda.gov/medical-devices
(A)https://www.fda.gov/medical-devices/products-and-medical-
procedures
3. https://cdsco.gov.in/opencms/opencms/en/Medical-Device-
Diagnostics/Medical-Device-Diagnostics
4. National Marrow Donor Program(NMDP), 2015

21. Thank You…
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