For manufacturing an in-vitro medical device of Class A & B, a loan license must be taken before starting the manufacturing process at a site of another licencee. Any manufacturer who intends to produce a device can apply to the concerned State Licensing Authority. A manufacturer has to go through an online application process for the medical device under the standards laid down by the CDSCO. The application process involves filling the Form MD-4 as an application on the online portal of the Ministry of Health and Family Welfare.
After evaluating the data, the State Licensing Authority can accept/reject the submitted proposal. The acceptance of the Loan Manufacturing License will be given by Form MD-6. The overall process takes about two to three months after applying.
Form MD-4 is used for applying for the Grant of Loan License to Manufacture for Class A or Class B medical devices. This form is for any manufacturer intends to sell or distribute Class A or Class B medical devices.
The Loan License to manufacture which is used for sale or distribution of Class A or Class B medical device given by the State Licensing Authority.
Any manufacturer who wants to manufacture a Class A or Class B in-vitro diagnostic device can make an application for the Loan License to Manufacture intended for sale or distribution.
 |
The application must be made under Form MD-4 to the State Licensing Authority. The form has to be submitted on the SUGAM online portal with the necessary documents and payment of the fees. |
The application for approval of one site manufacturing costs about INR 50000 and INR 1000 for each specific medical device.
The validity of an approved Loan Manufacturing License is five years.
Timeline to obtain the license is 2-3 months
The site for loan manufacturing should possess the license for manufacturing equivalent or higher classes medical device.
A test license should be acquired under Form MD-13 before applying for the loan license.
A verification and validation study reports are necessary before applying for the loan license for manufacturing Class A and Class B IVD devices.
For any rejected application after scrutiny of documents by the State Licensing Authority, the reasons for rejection will be recorded in writing, in forty-five days from the date of application.
The standards of the manufacturing site should comply with the standards of the Quality Management system as per the Fifth Schedule.
According to the Medical Devices Rule, 2017 (Third Schedule), there can be an audit by the State Licensing Authority of the manufacturing site after the application is submitted.
For the approval of a Loan license, an applicant must have the test license to manufacture for small quantity IVD products, which is used for clinical investigation or evaluation.
Audit of the manufacturing site is not necessary for Class A IVDs. The grant or loan license to manufacture for sale or distribution can be given to such a category without a prior site inspection. However, Class B, Class C, and Class D IVDs require the manufacturing site inspection before the license grant.
A loan license is a license given to a manufacturer which states the approval of manufacturing a medical device on a manufacturing site of another licensee; this includes using the manufacturing site of a different manufacturer to produce the same medical device. The loan license is given by the State Licensing Authority or by the Central Licensing Authority.
Yes, a PER is necessary before introducing the product in the market; for conducting the PER, an applicant must obtain a License in Form-29 when developing three or more trial batches of the IVD product. The prescribed number of samples from three consecutive batches of IVD products have to be sent to NIB (NOIDA) or any other notified laboratory. The PER test should be submitted to CDSCO and the concerned State Drugs Control Authority.
The applicant has to maintain the master file for each medical device. A detailed outline and contents have been stated in appendix – II of the Fourth Schedule.
In-Vitro Diagnostic devices are intended to be used outside the human or animal body. This device aims to diagnose a disease or disorder in human beings or animals. Under the Drugs and Cosmetics Act, 1940, these devices are under section 3 of sub-clause (i) of clause (b). The IVD devices are updated with recent changes, as per the Drugs and Cosmetics Act, 1940 under clause (b) of sub-clause (iv).
