Medical devices – Manufacturing license
In India, at present only notified medical devices are regulated as Drugs under the Drugs and Cosmetics Act 1940 and Rules made thereunder in 1945.
- (i) substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood and blood component collection bag with or without anticoagulant covered under sub-clause (i);
- (ii) substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and insecticides notified under sub-clause (ii); and
- devices notified from time to time under sub-clause (iv), of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940;
Must read articles, click below links:
IVD (In Vitro Diagnostics)
- 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.
- 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.
- Classification list of In Vitro Diagnostic Medical Devices have been published on the website of the Central Drugs Standard Control Organisation approved by CLA.
- 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
- 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.
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:
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.
Medical Device Testing Laboratories (MDTLs)
Central Govt. time to time notifies Medical Devices Testing Laboratories . For more details click below links:
List of MDTLs
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
DCGI Notice dt 03-09-2020 – Classification 24 categories of MD – reference SO 648(E) and GSR 102(E) dated 11-02-2020
DCGI Notice dt 03-09-2020 – Classification of 3 Categories of MD IVDs – reference SO 648(E) and GSR 102(E) dated 11-02-2020
DCGI Notice dt 15-05-2019 – Classification of newly notified Medical Devices
Fifth Schedule QMS
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:
List of Laboratory Instruments
We have provided list of laboratory instruments, click below link to exploxe:
DCGI Notice dt. 31-08-2020 – requirement of fees for change in address of authorized agent under MDR 2017
DCGI Notice dt 31-08-2020 – Submission of notarized documents for import of medical devices and In-Vitro kits in view of Covid-19
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
Medical Device Notifications
For various notifications of medical devices, click below link:
For notifications of Drugs Act and Drugs Rule , click below links:
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