In-Vitro Diagnostic Kit

Introduction

India regulate Import, Manufacture, Sale, Distribution and Clinical Performance of In-Vitro Diagnostic Medical Devices under Medical Device Rules 2017, w.e.f 1^st January, 2018.

Diagnostic kits manufactured in India require to obtain the license from State Licensing Authority (SAL) / Central Licensing Authority (CLA), depending upon their classification. However, importing diagnostic kits from foreign countries require import license from Central Licensing Authority (CDSCO).

In vitro diagnostic medical devices have been classified on the basis of complexity and risk involved with usage.

Low risk – Class A
Low moderate risk- Class B
Moderate high risk- Class C
High risk- Class D

RBridge Lifesciences can help you comply with CDSCO requirements and start selling your IVDs in India market. We provide following services.

1. Manufacturing License Approval from SLA/CLA

State Licensing Authorities review the Applications for Class A and Class B In-Vitro Diagnostics (IVDs) and grant the manufacturing license. Whereas, Central Licensing Authority reviews the Applications for Class C and Class D IVDs and grant the manufacturing license. We have the expertise to compile the dossier as per MDR 2017 requirement and can help you to get the manufacturing license.

Class of IVD

Class A&B

Class C&D

Application Form

Form MD-3

Form MD-7

Approval

Grant of Manufacturing License in Form MD 5

Grant of Manufacturing License in Form MD 9

2. Import License Approval from CLA

Import of IVDs are regulated by CDSCO. Foreign manufacturers must obtain import license before importing the product in India. An Authorised agent is required to hold the registration. Import license will be issued in the name of Authorized agent. He will be the importer of the product. Authorized agent will apply for grant of import license for IVD in Form MD- 14 to CDSCO on behalf of the manufacturer. The license would be obtained in Form MD-15. RBridge can help you to get the import license.

Class of IVD

Class A,B,C,D

Application Form

Form MD-14

Approval

Grant of Import License in Form MD 15

3. Test License

Manufactures require Test License to manufacture IVDs for testing, evaluation or for clinical investigations purpose. Similarly, importer need the Test License to import the IVDs for testing, evaluation and clinical performance. RBridge can help you to get the test license in timely manner.

Test License

Test license to manufacture IVD

Test license to import IVD

Application Form

Form MD-12

Form MD-16

Approval

Form MD-13

Form MD-17

4. New In-Vitro Diagnostic – Permission to Conduct Clinical Performance Evaluation

Any New IVD has to undergo a clinical performance evaluation before manufacturing / importing. The Application for grant of permission to conduct clinical performance evaluation of new IVD shall be made in Form MD-24 to the CDSCO. Permission to conduct clinical performance evaluation of new IVD is granted in Form MD-25. Preparing and filing the application in the correct format is required to get the approval. RBridge has capability and can help you to get the permission to conduct clinical performance evaluation.

Purpose

Permission for Clinical Performance Evaluation of New IVD

Application Form

Form MD-24

Approval

Form MD-25

5. New In-Vitro Diagnostic – Permission to Manufacture / Import

Any In-Vitro Diagnostic Device which does not have a predicate or similar device in the Indian market is considered to be a New In-Vitro Diagnostic Device. Such devices need approval from the Central Licensing Authority for their manufacture or Import in India. An application for grant of permission to import or manufacture a New IVD may be made to the CDSCO in Form MD-28 either by an Authorised agent in case of import or a manufacturer himself. After being satisfied with the information given along with application CDSCO will grant permission to import or manufacture new IVD in Form MD-29.

Purpose

Permission to Manufacture / Import New IVD

Application Form

Form MD-28

Approval

Form MD-29

6. Performance Evaluation of In-vitro Diagnostic Medical Devices

To get the manufacturing license or import license for Class B, Class C or Class D IVDs, manufacturer need to submit the copy of performance evaluation report. This clinical evaluation report must be issued in India by –

The central medical devices testing laboratory, or
A medical device testing laboratory registered under rule 83, or
Any laboratory accredited by the National Accreditation Board for Testing and Calibration Laboratories, or
Any hospital accredited by National Accreditation Board for Hospitals and Healthcare Providers, or
Any Central Government or State Government Laboratory of any hospital, or
Any institute, specified by the concerned State Licensing Authority or the Central Licensing Authority”.

SLA/ CLA may require the Performance Evaluation Report from above laboratories, for the following In-vitro Diagnostics which are intended for:-

HIV
HBV
HCV
Blood Grouping reagent
Cancer
Tuberculosis
Malaria
Dengue
Chikungunia
Syphlis
Typhoid
Influenza
ToRCH (Toxoplasma gondii, Rubella virus, Cytomegalovirus, Herpes simplex virus)
Chlamydia
Pneumonia
Methicilline-Resistant Staphylococcus Aureus
Entero virus
Marker for congenital disorder e.g. Screen test for Down’s Syndrome
Sexually transmitted agent i.e. Treponema pallidum, Neisseria gonorrhoeae, Human Papilloma Virus, Herpes Virus
Other life threatening Infections / agent.

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