Medical Devices – Manufacturing License

Also read the article: Understanding Quality Risk Management

IVD (In Vitro 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
    1. The requirements for grant of licence to Manufacture, Import, Clinical Performance, Sale and Distribution are prescribed in MDR-2017.
  2. 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:
    1. Low risk – Class A;
    1. Low moderate risk- Class B;
    1. Moderate high risk- Class C;
    1. High risk- Class D.
  3. Classification list of In Vitro Diagnostic Medical Devices have been published on the website of the Central Drugs Standard Control Organisation approved by CLA.
  4. The Central Licensing Authority shall be the competent authority for enforcement in matters relating to:
    1. Import of all Classes of In Vitro Diagnostic Medical Device
    1. Manufacture of Class C and Class D In Vitro Diagnostic Medical Devices
    1. Clinical Performance evaluation and approval of new in vitro diagnostic medical devices 
    1. Co-ordination with the State Licensing Authorities
  5. 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-
    1. Manufacture for sale or distribution of Class A or Class B In Vitro Diagnostic Medical Devices
    1. Sale, stock, exhibit or offer for sale or distribution of In Vitro Diagnostic Medical Devices of all classes.

How to obtain manufacturing license for Medical Devices

For obtaining manufacturing license for Medical Devices, the list of documents required is provided below. Download the pdf file and prepare the documents accordingly.

Procedure for obtaining manufacturing license for Medical Devices. Download the pdf file for more detail and prepare the documents accordingly.

Submit your application (Online at SUGAM Portal) after completing all the required documents. Click the link below for SUGAM Portal:

SUGAM Portal

Note: Requirements of some of documents and procedure for submission of application may vary from State to State

License retention fee

Procedure for submission of license retention fee. Download the pdf file for more detail and prepare the documents accordingly.


List of MDTLs

Central Govt. has notified 4 Medical Devices Testing Laboratories on 03-10-2019. For more details click below:

List of Notified bodies

Central Govt. has notified 8 Notified Bodies on 30-12-2019 for inspection for grant of manufacturing of Medical Devices Category B. For more details click below:

Central Govt. has notified 6 Notified Bodies on 31-07-2019 for inspection for grant of manufacturing of Medical Devices Category B. For more details click below:

Medical Devices have been divided into four categories i.e. A, B C & D. For more details of classification of Medical Devices dated 15-05-2019, click below:

Medical Devices categories

Medical Devices manufacturing units have to maintain the facilities as per Fifth Schedule,

Quality Management System for medical devices and in vitro diagnostic medical devices. For more details, click below:

Fifth Schedule QMS

Additional information for Medical Devices

For additional information for Medical Devices, click below:

Medical Devices Rule 2017

To download Medical Devices Rule 2017, click below

For various notifications of Medical Devices, Click here

Also read: FAQs on Medical Devices Rules, 2017

Also read various news on Medical Devices, Click here