The document discusses medical devices and in vitro diagnostics. It provides definitions and classifications of medical devices according to risk levels. It describes types of medical devices including diagnostic, therapeutic, and prosthetic devices. It discusses notified and non-notified in vitro diagnostic kits/reagents in India and examples. The regulation of medical devices in India is discussed along with the Drugs and Cosmetics Act. Manufacturers must comply with quality system regulations.

1. Prepared by – Yogini Chaudhari
Guided by- Dr.Ravindra Badhe
Department of QAT
D. Y. Patil Institute Of Pharmaceutical Science And Research
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2.  Introduction
 Classification of medical devices
 Types of devices medical devices
 Type of In-vitro diagnostic
 IVD’s Kits/reagent covered under notified diagnostic
 IVD’s Kits/reagent covered under not-notified diagnostic
 Recently developed in IVD’s devices
 Regulation system in India
 The Drug & cosmetic act on 1940
 Manufacture requires a quality system comply with 21 CFR part
820
 Significance of medical devices
 Reference
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3.  A medical devices are defined according to schedule M-III
creates a specific definition Devices intended for internal or
external use in the diagnosis, treatment, mitigation or
prevention of disease or disorder in human beings or animals
 A medical device is an instrument, apparatus, in vitro reagent ,
implant or other similar or related article.
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4.  Medical Devices are classified as per their risk level and intended use.
 By CDSCO (IMRDA) - 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.
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5. Medical devices
Diagnostic Devices Prosthetic Devices Therapeutic Devices
Notified Not-Notified
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6. 1) Definition. Diagnostic devices are devices used to identify the nature
or cause of a certain phenomenon, usually related to a medical
condition.
2) In vitro diagnostics are tests that can detect diseases, conditions, or
infections. Some tests are used in laboratory or other health
professional settings and other tests are for consumers to use at home
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7. Medical devices rules 2017 more types of IVD’s product fall
under notified requirement for conjugational and
autoimmune disorders genetic testing and sexually
transmitted infections would required import licenses /
performance evaluation under to obtained Indian market
approval
 In-vitro Diagnostic Devices for HIV.
 In-Vitro Diagnostic Devices for HBV.
 In-Vitro Diagnostic Devices for HCV.
 In-Vitro Blood grouping Sera.
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8.  In vitro Diagnostic kit for Malaria
 In vitro Diagnostic kit for Influenza
 In vitro Diagnostic kit for Dengue
 In vitro Diagnostic kit for Chikunguniya
 In vitro Diagnostic kit for Typhoid
 In vitro Diagnostic kit for Leptospira
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9.  HIV TRI-DOT - The HIV TRI-DOT test is a visual, rapid, sensitive and
accurate immunoassay for the differential detection of HIV-1& HIV-2
antibodies (IgG) in human serum or plasma using HIV-1 & HIV-2
Antigens immobilized on an immunofiltration membrane. The test is a
screening test for Anti HIV-1and HIV-2 and is for in vitro diagnostic
use only
 Other test –
RAPID TEST
a) The 4th Generation HIV TRI-DOT + Ag test
b) DIAGNOS HIV-DOT
ELISA Test –
a) Microlisa HIV Test
b) The 4th generation Microlisa HIV Test
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11.  HEPACARD is visual, rapid, sensitive and accurate one step immunoassay for
the qualitative detection of Hepatitis B surface antigen (HBsAg) in Human
serum or plasma. The assay is intended to be used as an aid in the recognition
and diagnosis of acute infections and chronic infectious carriers of the
Hepatitis B Virus(HBV)
 HEPALISA
 HEPALISA ULTRA-Hepalisa Ultra is designed for in-vitro qualitative detection
of Hepatitis B Surface antigen (HBsAg) in human serum or plasma and is used
as a screening test for testing of collected blood prior to transfusion.
 ....VideosHEPACARD - YouTube (360p).mp4
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12.  HCV TRI-DOT Test - The 4th Generation HCV TRI-DOT is a rapid,
visual, sensitive and qualitative in vitro diagnostic test for the detection
of antibodies to Hepatitis C virus in human serum or plasma.
It has been developed and designed with increased sensitivity for core
and antibodies using a unique combination of modified HCV antigen
 DIAGNOS HCV -DOT
 HCV Microlisa
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14.  Advantage mal card is a visual, rapid and sensitive immunoassay for
the qualitative diagnosis of P.falciparum and other Plasmodium
Species (P.vivax/ P.malariae/ P.ovale/ P.falciparum) based on
plasmodium parasite lactate dehydrogenase (pLDH)antigen in human
whole blood.
 Infection free- See through Device based on pLDH antigen Malaria
parasite in whole blood
 Excellent Sensitivity & Specificity as per WHO Malaria RDTs
Evaluation.
 Longer shelf life of 24 months at 4-30° C.
 Easy to interpret Colour Bands
 Results within 20 minutes.
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15.  ....VideosAdvantage Pan Malaria Card - YouTube
(360p).mp4
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16.  Sample type - Human nasopharyngeal samples (swabs, aspirates,
washes)
 Time to result- 10 minutes
 Sample volume - 3 drops of sample extract
 Storage temperature - 2 – 30°C
 Shelf life 20 months from date of manufacturing
 Influenza A+B test in line with the WHO recommendation
 ....VideosAlere BinaxNOW® RSV Product Demo - YouTube
(360p).mp4
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17.  Dengue day one test –
Dengue Day 1 Test is a rapid solid phase immune-chromatographic test
for the qualitative detection of Dengue NS1 Antigen and differential
detection of IgM and IgG antibodies to Dengue virus in Human
serum/plasma. This test is for in vitro diagnostic use only and is
intended as an aid in the earlier diagnosis of Dengue infection &
presumptive diagnosis between primary and secondary Dengue
infection.
 First line testing kit for detecting dengue infection from day 1 using NS1
Antigen & differential detection of IgM & IgG Antibodies.
 Diagnosis of both Primary & Secondary Infection.
 Detects all 4 serotypes of Dengue virus
 Detection of all the 4 Dengue serotypes (DEN-1, DEN-2, DEN-3 and
DEN-4).
 Highly Sensitive & Highly Specific
 Long shelf life: 24 months at 2-30°C
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19.  Advantage Chikungunya IgM Card is a visual, rapid, sensitive,
qualitative immunoassay for the detection of Chikungunya specific
IgM antibodies in human serum or plasma
 Based on Sandwich Immunoassay principle.
 One step test procedure.
 Results within 15 minutes.
 Bio hazard free, fully covered, see through device.
 No Instruments required.
 Excellent Sensitivity & Specificity.
 Long Shelf life: 18 months at 2-30° C
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20.  Swashtya slate – is Bluetooth –enable integrated
diagnostic kit that works with an android based mobile
system to perform 33 diagnostic tests and is equipped with
various application that are created strategically to increase
access to health education in the country .through the
mobile number of mobile application it is able to record
patent's medical history .
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22.  Diagnosing Ear Infections With a New Smartphone Gadget
 Complex Biological Computer Commands Living Cells (26 July 2017)
Researchers have developed a biological computer that functions inside
living bacterial cells and tells them what to do, according to a report
published in Nature. Composed of ribonucleic acid, or RNA, the new
“ribocomputer” can survive in the bacterium E. coli and respond to a
dozen inputs, making it the most complex biological computer to date
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23.  The drugs controller general (India) of central drugs
standard control organization (CDSCO) is the regulatory
authority that governs the import of IVD kits/reagents in
India to ensure the products which are approved,
manufactured and imported are of acceptable quality,
safety and efficacy.
 CDSCO is the only government body which regulate the
medical devices
 all these are now being taken into to form the Indian medical
device regulatory act (IMRDA).
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24.  Indian Medical Devices Regulatory Act come in force December 31,
2009
 Inputs to be sent to Dr. B Hari Gopal , Adviser Department of
Science and Technology, New Delhi .
 Principle :-
1) Should not compromise health and safety
2) Design and manufacture of devices must conform with safety
principles
3) Long term safety should be ensured
4) Benefits of the devices must outweigh any side effects
5) Medical devices should be useful for the intended purpose
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25.  Covers the pharmaceutical products and cosmetic.
 Added medical devices as early as1992(syringes , needles , test
kits etc.)
 As per the latest list of regulated medical devices , issued on the
20/04/2010 , listed following devices:
 Disposable hypodermic needles
 Disposable hypodermic syringes
 Disposable perfusion sets
 In vitro diagnostic devices for HIV, HbsAg.
 Cardiac stents
 Catheters
 Intra ocular lenses
 Drug eluting stents
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26. Class-1 Class-2 Class-3
Most Manufacturers must comply with the FDA
Quality System Regulation (21 CFR part 820).
This is also known as good manufacturing practice (GMP).
Companies that outsource manufacturing must still comply. Supplier too!
FDA does not recognize ISO 13485 or ISO 9001 and does not certify quality
system.
Instead FDA conducts Random Inspection for compliance with 21 CFR 820.
They do inspect class-3 device Manufacturer prior to PMA approval
FDA inspection can happen any time after online registration .
Manufacturers requires a quality system comply with
21 CFR part 820
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27. •The Quality System Regulation Effective on June 1, 1997 for medical devices.
•ISO 13485:2003 and 21 CFR Part 820 are harmonized; Each may have
additional requirements but they do not conflict with one another.
It contains:
•Subpart A—General Provisions
•Subpart B—Quality System Requirements
•Subpart C—Design Controls
•Subpart D—Document Controls
•Subpart E—Purchasing Controls
•Subpart F—Identification and Traceability
•Subpart G—Production and Process Controls
•Subpart H—Acceptance Activities
•Subpart I—Nonconforming Product
•Subpart J—Corrective and Preventive Action
•Subpart K—Labeling and Packaging Control
•Subpart L—Handling, Storage, Distribution, and Installation
•Subpart M—Records
•Subpart N—Servicing
•Subpart O—Statistical Techniques
21 CFR Part 820
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28.  The medical development in terms of drugs and devices has brought
about the robust change in the life of the people. Medical devices
have extended the ability of physicians to diagnose and treat
diseases, making great contributions to health and quality of life.
 Like medicines and other health technologies, they are essential for
patient care at the bedside, at the rural health clinics or at the large,
specialized hospitals.
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29.  Jeffery DB. The regulation of medical devices and the role of medical
devices agency Br J Clin pharmacol 2001;52:299-35
 Schedule M-III. Requirement for the manufacture ,import and scale of
medical devices .2009
 Briand H, et Al. Performance Evaluation of BIONEXIA® Influenza A+B,
Rapid diagnosis test for the qualitative detection of Influenza type A
and type B antigens. Poster presented at RICAI congress Dec 1-2, 2011
469
 WHO recommendations on the use of rapid testing for influenza
diagnosis. 2005
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30.  Anuaja R Shah,Goyal RK .Status of the regulation for medical devices.
Indian J pharmal sci 2008;70:695-700.
 Moesker FM, van Kampen JJ, Aron G, Schutten M, van de Vijver DA,
Koopmans MP, Osterhaus AD, Fraaij PL. Diagnostic performance of
influenza viruses and RSV rapid antigen detection tests in children in
tertiary care. J Clin Virol. 2016;79:12-7.
 Picard C, et al. Comparative Evaluation Of BIONEXIA Influenza A+B
To QuickVue Influenza A+B Test For The Detection Of Influenza In
Pediatric Samples. Poster presented at ESPID congress May 28-June1,
2013. Milan, Italy
 http://cdsco.nic.in/Drugs&CosmeticAct
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