InVitro Diagnostics

  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.

  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.

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 External Performance evaluation of IVD's under MDR further guidance 2019-Oct-11 328 KB
2 Performance evaluation of In-Vitro Diagnostic to the In Vitro Diagnostic Medical Device Laboratory 2019-Oct-09 2,653KB
3 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
4 Letter regarding MSC,NCC & performance certificate 2018-Aug-08 407 KB
5 Quality Control Testing of viral load monitoring kits HIV, HBV, HCV 2018-Jul-24 640 KB
6 Inspection of manufacturing site of Class C and Class D medical devices including IVDMD under MDR-2017 2018-Apr-09 259 KB
7 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
8 Designation of CMDTL & MDTL including IVDMD under MDR-2017 2018-Feb-27 327 KB
9 Office Order regarding for revised criteria of acceptance of sensitivity and specificity of IVD Kit 2017-Jun-13 569KB
10 Dengue Chkngunya IgM Elisa 2017-May-12 330 KB
11 Regulatory approval relating to combination products for HIV, HBV, HCV recommended for concomitant use by WHO 2017-Mar-20 433 KB
12 Notice regarding Import of Radiopharmaceutical Products/Radio-Immuno Assay for (in vivo or in vitro) diagnostic use 2017-Feb-20 947KB
13 Capacity utilization for quality control testing for biological at NIB Noida 2016-Mar-30 282 KB
14 Acceptance Criteria for test and examination of Blood Glucose Test Strips & Analyzer base Glucose reagent 2016-Feb-16 55 KB
15 Specificaiton and Criteria for Acceptance_bood glucose test strip 2014-Aug-07 460 KB
16 IVD Office Order 2014-Jun-24 1436 KB
17 Constitution of In Vitro Diagnostic Device Advisory Committee 2014-Mar-07 1200 KB
18 Specification and criteria for acceptance for test performed on syphilis raid and ELISA kits 2014-Feb-14 250 KB
19 Clarification reg NOC to import of diagnostics kit or reagent dated 27.12.2012 2012-Dec-27 235 KB
20 Clarification reg NOC to import of diagnostics kit or reagent for ROU 2012-Jul-13 201 KB
21 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