What is Form MD 12 and MD 13?

Form MD 12 - Application for obtaining the license to manufacture medical devices for the purpose of conducting clinical investigations, evaluation, tests, examination, training or demonstration. Form MD 13 - License to manufacture medical devices for the purpose of conducting clinical investigations, tests, evaluation, demonstration or training.

How to apply for Test License To Manufacture Medical Devices?

Step 1: Register 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

Test license to Manufacture Medical Devices in India - MD 12 & MD 13

Q: Government Fee For Test License To Manufacture Medical Devices?

INR 500 is the fees to be paid while filling the form.

Q: Validity of Test License To Manufacture Medical Devices

The validity for the Test License is 3 Years.

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CliniExperts dedicated team helps in getting the Permission For Test License To Manufacture Medical Devices. We strategically plan the process for regulatory approval of manufacturing test license for medical devices in Form MD 13.

Test license to Manufacture Medical Devices (Form MD 12, 13) – Overview

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.

Who Can Apply?

Any person who wishes to manufacture medical devices for testing purpose can apply for Form MD 13.

How To Apply?

The Applicant must follow the following process:

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

Validity

The validity for the Test License is 3 Years

Fee Involved

INR 500 is the fees to be paid while filling the form.

Important Documents

Brief description of the medical device to be manufactured including intended use, material of construction, design, etc.
List of Qualified personnel

Quality certificates
List of equipment
Schematic plan of premises

Timeline to get MD 13from Central Drugs Standard Control Organisation

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Essential Tips

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.

Expert Advise

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.

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Frequently Asked Questions

Is it possible to mention multiple sites in a single test license application for the purpose of Clinical Investigation, Testing, Evaluation, demonstration, and training?

Yes. It is possible to list multiple sites where the training or testing is going to be conducted in the same application form.

In cases where the medical device has to be transported somewhere else, how can this be accomplished with the ones mentioned in the test license?

In such case, the Central Licensing Authority should be informed in writing before proceeding

Does CDSCO inspect the Test manufacturing facility?

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.

In how many days should an applicant may apply to CDSCO in case license has been cancelled?

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.

Test license to Manufacture Medical Devices in India - MD 12 & MD 13

CliniExperts dedicated team helps in getting the Permission For Test License To Manufacture Medical Devices. We strategically plan the process for regulatory approval of manufacturing test license for medical devices in Form MD 13.

Test license to Manufacture Medical Devices (Form MD 12, 13) – Overview