In India, small quantities of Class A, Class B, Class C, or Class D medical devices may be manufactured by procuring a Test License in Form MD-13 issued by CDSCO. These devices can be used for the purpose of clinical research, testing, evaluation, demonstration, or training.
A person who intends to manufacture a medical device must apply for a Test license by filling out a Form MD-12 from an identified online portal of the Ministry of Health and Family Welfare for the purpose of test, evaluation, demonstration, and training. The Ministry of Health and Family Welfare will then issue a Test license in the Form MD-13.
Any person who wishes to manufacture medical devices for testing purpose can apply for Form MD 13.
The application is done with reference to MDR 2017. Registration on the Sugam portal is mandatory for applying for the test license
|Step 1: Register the applicant on Sugam portal|
|Step 2: Draft application|
|Step 3: Upload mandatory documents as per check list of MD-12|
|Step 4: Payment of Requisite government fee|
|Step 5: Submit the application on online medical device portal|
The validity for the Test License is 3 Years
Government Timeline for Test License to manufacture Medical Device is 30 working Days
The quantity to be manufactured must be justified and clarified during the submission process.
The name of the place where demonstration, testing, evaluation, clinical trials or training will be conducted should be finalized in the submission preparation process.
The specifications of the product, such as material, intended use, and description, must be submitted during the process.
It is important to justify the quantity to be manufactured by providing batch details, quantity to be used, and quantity to be retained.
The test protocol or clinical investigation plan is a crucial requirement when applying for a test license for clinical investigation purposes.
The licensee must keep a record of the quantity and disposition of medical devices manufactured, tested, and stocked.
Test licenses must be used exclusively for the purpose for which they were obtained.
Yes. It is possible to list multiple sites where the training or testing is going to be conducted in the same application form.
In such case, the Central Licensing Authority should be informed in writing before proceeding
Yes, Medical Device Officers may enter the facilities where the medical devices are manufactured, with or without notice, to verify that only clinical investigations, tests, evaluations, examinations, demonstrations, and training are conducted on those devices that have received due Test License.
A licensee, whose license has been cancelled, must appeal to the Central Government within forty-five days from the date of the order to re-apply for the same license. After this, the license will be permanently cancelled.