A medical device under Class A, B, C, or D can be manufactured in small quantities for various purposes; for instance, a medical device can be used for clinical investigation, testing, evaluation, examination, and demonstration or training. For manufacturing, any medical device, a particular set of procedures have to be followed, which is laid down by the CDSCO. The manufacturer has to apply to the Central Licensing Authority for approval concerning the guidelines of CDSCO. The Central Licensing Authority maintains the quality and standards for manufacturing any medical device as the highest regulatory body in the country. Any manufacturer who wishes to manufacture a medical device must apply to the Central Licensing Authority by submitting Form MD-12. The form states the purpose for manufacturing a medical device, which can be for testing, evaluation, demonstration, or training. The test license will be given in Form MD-13 by the online portal of the Ministry of Health and Family Welfare. The procedure duration can take up to 30 days for obtaining a test license
Any person who wishes to manufacture small quantities of medical devices concerning the in-vitro diagnostic medical devices can apply to the Central Licensing Authority. The applicant has to state the purpose of manufacturing medical devices.
|The applicant must apply to the Central Licensing Authority by registering on the SUGAM portal.|
|The applicant must apply with Form MD-12 with the required fees for each medical device.|
Validity for test license to manufacture is 3 Years
The documentation of every manufacturing unit, with the manufacturer’s name, quantity specified, and date of the manufactured device, should be well recorded and kept with the holder of the test license
For every consignment of medical device, an invoice or a statement should be generated with the name and quantity of the manufactured medical device.
The approved test license should be used specifically for the clinical investigation, testing, evaluation, examination, demonstration, or training
The holder of the test license shall maintain record of the activities undertaken including the name of manufacturer, quantity manufactured and date of manufacture
The consignment of medical device shall be accompanied by an invoice or statement showing the name and quantity of medical device.
The Test license must be exclusively used for the purpose of clinical investigations, test, evaluation, examination, demonstration or training
The Test License is the approved license given by the Central Licensing Authority for manufacturing or importing small quantities of in-vitro diagnostic medical devices for clinical investigation, test, evaluation, demonstration, or training purposes
Yes, you can mention multiple manufacturing sites by a single test license application intended for clinical investigation, testing, evaluation, demonstration, or training.
Yes, the applicant firm must obtain a license in Form-29 for developing three or more IVD product trial batches. A prescribed number of sample from three consecutive test batches of IVD medical devices have to be sent to the NIB (NOIDA) or the other notified laboratory. The PER must be sent to the CDSCO and the concerned State Drugs Control Authority
In such scenarios, the applicant shall inform the Central Licensing Authority before relocating the medical device.
After the suspension of the test license, the manufacturer/licensee can appeal to the authority within forty-five days from the date of a suspension order.