- For manufacturing an in-vitro diagnostic medical device (IVD) of Class C & D, a loan license must be taken before starting the manufacturing process. Any manufacturer who intends to produce a device at a site where the same device is being produced by another manufacturer must get a loan license. The person wanting to manufacture can apply to the Central Licensing Authority. A manufacturer has to go through an online application process for the medical device under the standards laid down by the CDSCO on the SUGAM portal. The application process involves filling the Form MD-7 as an application on the online portal of the Ministry of Health and Family Welfare.
After evaluating the data, the Central Licensing Authority can accept/reject the submitted proposal. The Loan Manufacturing License will be granted as Form MD-9. The overall process takes about two to three months after applying. A loan license generally provides permission for a manufacturing site to the manufacturer for IVD production intended for sale or distribution.
Any manufacturer who wants to manufacture a Class C or Class D in-vitro diagnostic device can make an application for the Grant of License to manufacture for sale or distribution.
|The application must be made under Form MD-7 to the Central Licensing Authority. The application must be filled on the SUGAM portal by uploading the listed documents and paying the stated fees.|
|After the registration, make sure you apply for the Test License Form MD-13 and performance evaluation test.|
The validity of an approved Loan Manufacturing License is five years.
Timeline to obtain the license is 2-3 months
Before applying for a manufacturing license, an applicant must file for the test license to manufacture a small quantity of IVD medical devices for testing and evaluating the IVD product.
The Quality Management System (QMS) should be followed concerning the rules in Fifth Schedule.
A performance evaluation study has to be conducted in a CDSCO listed laboratory as per the products mentioned by the CDSCO notifications. The study reports have to be sent to the CDSCO for evaluation.
The Central Licensing Authority can use the service of an expert in the field of IVD for evaluating the application of Class C or Class D medical devices.
If the Central Licensing Authority found any alteration in the application or the documents, the authority can reject the submitted application.
The Quality Management System is a necessary aspect concerning the Fifth Schedule; if any applicant fails to comply with these standards, the application will be rejected.
An applicant should ensure that Class C or D conforms to the Quality Management System requirements stated in the Medical Devices Rules, 2017
An applicant is required to apply for the Test License for manufacturing medical devices for clinical investigation or test or evaluation or demonstration or training in cases where a predicate is not available for the medical device.
The applicant has to conduct the Clinical Performance Evaluation Study from a listed laboratory by the CDSCO and submit the reports to the C.
Class C and Class D IVDs require inspection before the Grant of Manufacturing License.
Yes, a PER is necessary before introducing the product in the market; for conducting the PER, an applicant must obtain a License in Form MD-29 for developing three or more trial batches of the IVD product. From these batches prescribed number of sample IVD products from three consecutive batches 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 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. These devices aim to diagnose a disorder or medical condition 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).
Ans – IVDs are classified under Medical Devices Rule, 2017 of Chapter II, Rule 4 and sub-rule (2). The parameters of IVDs are listed under Part II of the First Schedule, which classifies IVDs as –