Central Drugs Standard Control Organization

Directorate General of Health Services
Ministry of Health & Family Welfare
Government of India

InVitro Diagnostics

About IVD

  1. In India, import, manufacturing, sale and distribution of In Vitro Diagnostic Medical Devices are regulated as Drug under sub-clause (i) of clause (b) of section 3 and sub-clause (iv) of clause (b) of section 3 of Drugs and Cosmetic Act and Rules

    • The requirements for grant of licence to Manufacture, Import, Clinical Performance, Sale and Distribution are prescribed in MDR-2017.

  1. In vitro diagnostic medical devices shall be classified on the basis of risk parameters as specified in Part II of the First Schedule, as under:

    • Low risk - Class A;

    • Low moderate risk- Class B;

    • Moderate high risk- Class C;

    • High risk- Class D.

  1. Classification list of In Vitro Diagnostic Medical Devices have been published on the website of the Central Drugs Standard Control Organisation approved by CLA.

  2. The Central Licensing Authority shall be the competent authority for enforcement in matters relating to:

    • Import of all Classes of In Vitro Diagnostic Medical Device

    • Manufacture of Class C and Class D In Vitro Diagnostic Medical Devices

    • Clinical Performance evaluation and approval of new in vitro diagnostic medical devices 

    • Co-ordination with the State Licensing Authorities

  3. The State Drugs Controller, by whatever name called, shall be the State Licensing Authority and shall be the competent authority for enforcement in matters relating to-

    • Manufacture for sale or distribution of Class A or Class B In Vitro Diagnostic Medical Devices

    • Sale, stock, exhibit or offer for sale or distribution of In Vitro Diagnostic Medical Devices of all classes.

Functionalities

  1. Grant of Import Licence: The applicant shall make an application in MD-14 in sugam online portal for grant of import licence in MD-15 to import In Vitro Diagnostic Medical Devices.

  2. Grant of licence or loan licence to manufacture for sale or for distribution: The applicant shall make an application in MD-7 & MD-8 in sugam online portal for Grant of manufacturing Licence / Loan Licence to Manufacture for Sale or for Distribution of Class C or Class D in MD-9 & MD-10.

  3. Grant of test licence to manufacture for test, evaluation, clinical investigations, etc.: The applicant shall make an application in MD-12 in sugam online portal for licence in MD-13 to manufacture In Vitro Diagnostic Medical Devices for purpose of clinical investigations, test, evaluation, examination, demonstration or training.

  4. Grant of test licence to import for test, evaluation, clinical investigations, etc.: The applicant shall make an application in MD-16 in sugam online portal for licence in MD-17 to import In Vitro Diagnostic Medical Devices for purpose of clinical investigations, test, evaluation, examination, demonstration or training.

  5. Permission to conduct clinical performance evaluation for new in vitro diagnostic medical device: The applicant shall make an application in in MD-24 in sugam online portal for grant of permission to conduct clinical performance evaluation of new in vitro diagnostic medical device in MD-25.

  6. Permission to import or manufacture new in vitro diagnostic medical device: The applicant shall make an application in MD-28 in sugam online portal for grant of permission to Import or Manufacture for sale or for distribution of new in vitro diagnostic medical device in MD-29.

  7. Registration of medical device testing laboratory: The applicant shall make an application in MD-39 in sugam online portal for grant of registration in MD-40 to medical device (IVDMD) testing laboratory for test or evaluation on behalf of manufacturer.

  8. Preparation of Guidance and FAQ on key activities.

  9. Processing of application for Issuance of Free Sale Certificate for domestic manufacturers In Vitro Diagnostic Medical Devices.

  10. Complaint, NSQ Verification.

  11. Updating the list as per the Classification of IVD Medical Devices from time to time.

  12. Post Approval Changes in respect of In-Vitro Diagnostic Medical Devices.

  13. Constitution of IVD exerts committee.

  14. Inspection of manufacturing site for compliance of QMS by CLA/SLA.

  15. Capacity building activities of technical management.

  16. Registration of notified bodies for audit of Class A and Class B.

Processes

Organogram

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Guideline

S.no Title Release Date Download Pdf Pdf Size
1 IN-VITRO DIAGNOSTIC ALERT FOR PRODUCT " BBL(TM) MGIT(TM) Mycobacteria Growth Indicator Tube 2018-Mar-03 196 KB
2 In-VitroDdiagnostic alert for product " BBL(TM) MGIT(TM) Mycobacteria Growth Indicator Tube" 2018-Jan-01 196kb
3 IVD Diagnostic Kit Alert for Comipack ABD 2018-Jan-01 74kb
4 IVD Diagnostic Kit Alert for Mediclone D 2018-Jan-01 144kb
5 Medical Device Adverse Event reporting form 2017-Jan-01 1,655kb
S.no Title Release Date Download Pdf Pdf Size
1 Applicability of IS/ISO 15197 2013 version regarding glucometer test strips 2018-May-17 249 KB
2 CLARIFICATION ISSUED BY CDSCO ON IVD (IVD's) 2017-Feb-17 210 KB
3 CLARIFICATION REGARDING NOC FOR IMPORTS OF DIAGNOSTIC KITS / REAGENTS (IVD's) 2017-Feb-17 235 KB
4 DIAGNOSTIC KIT ( REGISTRATION CERTIFICATE) (IVD's) 2017-Feb-17 135 KB
5 USE OF RAPID TEST KITS FOR TESTING OF HIV AND HCV IN BLOOD BANKS (IVD's) 2017-Feb-17 467 KB
6 List of Diagnostic Kits for Blood Bank 2017-Feb-17 326 KB
7 Minutes of the Meeting of the Experts Committee to Examine the Specification and Criteria for Acceptance for Test Performed on ' Syphilis Rapid and Elisa Kits' 2017-Feb-17 2028 KB
8 TEST LICENSE (IVD's) 2017-Feb-17 103 KB
9 USE OF DIAGNOSTIC KITS OF HBsAg, HIV AND HCV IN BLOOD BANKS OR PATHOLOGICAL LABS (IVD's) 2017-Feb-17 313 KB
10 Guidance Document on Common Submission Format for Import of Non-Notified Diagnostic Kits in India (IVD's) 2017-Feb-17 611 KB
11 Guidance Document on Common Submission Format for Registration/ Re-Registration of Notified Diagnostic Kits in India (IVD's) 2017-Feb-17 977 KB
12 DIAGNOSTIC KIT (IMPORT LICENSE) (IVD's) 2016-Feb-17 105 KB
13 DRAFT SCHEDULE M IV (IVD's) 2015-Feb-17 2007 KB
14 Guidance Document on Common Submission Format for Import of Notified Diagnostic Kits in India (IVD's) 2015-Feb-16 592 KB
15 Minutes of Meeting of IVD Industry Held on 07-08-2012 at CDSCO(HQ), New Delhi 2012-Feb-17 266 KB
S.no Title Release Date Download Pdf Pdf Size
1 CDSCO updated list of laboratories to conduct Performance evaluation of IVDs dated 29.11.23 2023-Dec-06 654 KB
2 Updation of classification in IVD medical devices under the provision of MD Rules 2017 2023-Oct-25 1473 KB
3 CDSCO updated list of laboratories to conduct Performance evaluation of IVDs dated 26.09.2023 2023-Sep-29 654 KB
4 CDSCO updated list of Laboratories for conducting Performance Evaluation of In - Vitro Diagnostic Medical Device 2023-May-22 214 KB
5 Draft Guidance document on Guidance on Stability Studies of In-Vitro Diagnostic Medical Device (IVDMD) 2022-Jul-07 781 KB
6 Draft Guidance document on Overview on Performance Evaluation / External Evaluation of In vitro Diagnostic Medical Device (IVDMD) 2022-Jul-07 702 KB
7 Draft Guidance document on Guidance on Post-Market Surveillance of In-vitro Diagnostic Medical Device (IVDMD) 2022-Jul-07 594 KB
8 List of laboratories for conducting Performance evaluation of IVD analyzers, instruments and software 2022-May-05 103 KB
9 Updated list of laboratories for conducting Performance evaluation of IVD reagents/kit 2022-May-05 208 KB
10 Classification in IVD medical devices under the provision of MD Rules 2017 2021-Jul-23 45667 KB
11 Supply of essential In-Vitro Diagnostic testing reagents / kits for inflammatory markers such as IL-6 (Interleukin 6), D-Dimer and C-reactive protein (CRP) 2021-Apr-29 968 KB
12 Mentioning of analytical sensitivity of HIV p24 antigen in 4th generation HIV kits 2021-Mar-22 586 KB
13 GUIDELINES FOR VALIDATION AND BATCH TESTING OF COVID-19 DIAGNOSTIC KITS 2020-Jun-04 2174 KB
14 Revised Guidance list of Laboratories on Performance Evluation of IVDm (dated-24/02/2020) 2020-Feb-24 849 KB
15 External Performance evaluation of IVD's under MDR further guidance 2019-Oct-11 328 KB
16 Expansion of testing of IVDs for Clinical Chemistry reagents/Kits at NIB Noida under the provision of Medical Device Rules 2017 2019-Oct-07 995 KB
17 Performance evaluation of In-Vitro Diagnostic to the In Vitro Diagnostic Medical Device Laboratory 2019-Oct-04 2653 KB
18 Letter regarding MSC,NCC & performance certificate 2018-Aug-08 407 KB
19 Quality Control Testing of viral load monitoring kits HIV, HBV, HCV 2018-Jul-24 640 KB
20 Inspection of manufacturing site of Class C and Class D medical devices including IVDMD under MDR-2017 2018-Apr-09 259 KB
21 Proposal invited for designation of Central Medical Device testing lab for Medical devices including In-Vitro Diagnostic medical Device under Medical Devices Rules, 2017 2018-Mar-01 638KB
22 Designation of CMDTL & MDTL including IVDMD under MDR-2017 2018-Feb-27 327 KB
23 Office Order regarding for revised criteria of acceptance of sensitivity and specificity of IVD Kit 2017-Jun-13 569KB
24 Dengue Chkngunya IgM Elisa 2017-May-12 330 KB
25 Regulatory approval relating to combination products for HIV, HBV, HCV recommended for concomitant use by WHO 2017-Mar-20 433 KB
26 Notice regarding Import of Radiopharmaceutical Products/Radio-Immuno Assay for (in vivo or in vitro) diagnostic use 2017-Feb-20 947KB
27 Capacity utilization for quality control testing for biological at NIB Noida 2016-Mar-30 282 KB
28 Acceptance Criteria for test and examination of Blood Glucose Test Strips & Analyzer base Glucose reagent 2016-Feb-16 55 KB
29 Specificaiton and Criteria for Acceptance_bood glucose test strip 2014-Aug-07 460 KB
30 IVD Office Order 2014-Jun-24 1436 KB
31 Constitution of In Vitro Diagnostic Device Advisory Committee 2014-Mar-07 1200 KB
32 Specification and criteria for acceptance for test performed on syphilis raid and ELISA kits 2014-Feb-14 250 KB
33 Clarification reg NOC to import of diagnostics kit or reagent dated 27.12.2012 2012-Dec-27 235 KB
34 Clarification reg NOC to import of diagnostics kit or reagent for ROU 2012-Jul-13 201 KB
35 Testing of Biochemical kits for estimation of glucose 2010-Aug-26 133 KB
S.no Title Release Date Download Pdf Pdf Size
1 S.O. 5980(E) dated 03.12.2018 2018-Dec-03 279 KB
2 S.O. 1352(E) dated 23.03.2018_G.S.R. 1074(E) dated 30.10.2018 2018-Oct-30 445 KB
3 G.S.R. 729 (E) dated 01.08.2018 2018-Aug-01 1742 KB
4 S.O. 3400(E) dated 11.07.2018 2018-Jul-11 2089 KB
5 S.O. 2237(E) dated 01.06.2018 2018-Jun-01 1752 KB
6 GSR 600 (E) Drugs [IVD's] 2017-Feb-17 1336 KB
7 TB Sero Notification [IVD's 2017-Feb-17 136 KB
8 G.S.R. 103(E) dated 02.02.2017 2017-Feb-02 1121 KB
9 G.S.R. 78(E) dated 31.01.2017 2017-Jan-31 3029 KB
10 G.S.R. 908 (E) dated 22.12.2014 2014-Dec-22 138 KB
11 GSR 433 (E) dated 7.June 2012 2012-Jun-07 136 KB