Unit-1: Introduction and Classification of

Medical Devices

Dr. Sachin Gupta

Division of Research and
Development
 Course Content

1. Introduction and Classification of Medical Devices :

2. Medical devices definition, design life cycle

3. Design process versus design control

4. Design models-Pahl and Beitz, Pugh model

5. Divergent convergent model

6. Common design management models

Biomedical Instrumentation : Biomedical
Instrumentation is the field of creating such
instruments that help us to measure, record
and transmit data to or from the body
Basic Objectives of Instrumentation System
Quick Quiz…

The Feedback system is mainly……………… type

A. Open Loop
B. Closed Loop
C. Both
D. None
Classification of Instruments Used
CLASSIFICATION OF INSTRUMENTS
Engineering Medical

Indicating
Diagnostic
Recording
Therapeutic
Monitoring

Data Logging Supplementary

Analysis
Medical Devices are notified as DRUGS under Drugs &
Cosmetics Act.

Section 3 (b) (iv) defines, Medical Devices as

“Devices intended for internal or external use in the diagnosis, treatment
mitigation or prevention of disease or disorder in human beings or
animals”
D & C Act: Instrument intended for internal or external use in the diagnosis,
treatment, mitigation or prevention of disease or disorder in human beings or animals,
as may be specified from time to time by the Central Government by notification in the
Official Gazette, after consultation with the Board.

As per USFDA - “An instrument, apparatus, implement, machine, contrivance,

implant, in vitro reagent, or other similar or related article, including a component
part, or accessory which is recognized in the official National Formulary, or the United
States Pharmacopoeia, or any supplement to them, intended for use in the diagnosis of
disease or other conditions, or in the cure, mitigation, treatment, or prevention of
disease, in man or other animals, or intended to affect the structure or any function of
the body of man or other animals, and which does not achieve any of it's primary
intended purposes through chemical action within or on the body of man or other
animals and which is not dependent upon being metabolized for the achievement of
any of its primary intended purposes."
Quick Quiz…

The Full form of USFDA is

A. U.S. Food and Drug Agency

B. U.S. Food and Drug Administration
C. U.S. Food and Drug Association
D. None
 Medical Devices are classified as per their risk level and intended use.

By CDSCO (IMRDA) & MDD- Risk Based classification

 Class A (Class-I)– Devices involving low risk levels (Thermometer)

 Class B (Class-II a)– devices involving low to medium risk (Hypodermic Needle)

 Class C (Class-II b)– Devices involving moderate to high risk (Lung ventilator)

 Class D (Class-III)– Devices involving high risk. (Heart valve, implantable device)

By USFDA
 Class-I (Low Risk):Elastic bandages , Examination Glove, Adult Incontinence Pad

Class –II (Medium Risk): Catheter Cannula, Dialyzer , Piston syringe , Needle,

Infusion Pumps, Bone fixation screw, Blood pressure Kit

 Class-III (High risk): Pacemakers, Dental Lasers, Heart Valves.
 FDA ‘Approval Process’ by Class of Device

Class-1 Class-2 Class-3

FDA clearance required.

No FDA approval needed* Typically via 510 (K) FDA approval required.
Must register device & Premarket notification Typically via Premarket
company on FDA website. submission. (PMA) approval process

Approval of Class-3 Devices is complicated and involves clinical trials.

Less than 10% of devices are considered Class-3 by the FDA.

* Most Class-1 devices are 510 (K) Exempt

Quick Quiz…

Dialyzer process comes under

A. Class-I
B. Class-II
C. Class-III
D. None
 B

A C
Quick Quiz…

Drug inspection comes under

A. Diagnose Cell
B. Medical Device Cell
C. Both
D. None
Functions of Medical Device
Division
• Import Registration and Licensing of Medical
Devices
• Approval of New Medical Devices
• Manufacturing License to Indigenous Manufacturer under
CLAA Scheme
• Grant of Test License
• NOC’s for Import/Clarifications
• Neutral Code For Export
• Clinical Trials