Test License for Medical Devices – Overview
In India, individuals have the opportunity to produce limited quantities of medical devices categorized under Class A, Class B, Class C, or Class D by acquiring a Test License (Form MD-13) from CDSCO. These devices are designated for applications like clinical research, testing, evaluation, demonstration, or training.
Read about CDSCO Classifications of Medical Devices
To commence medical device manufacturing, one must initiate the process by submitting an application for a Test License via Form MD-12 on the designated online portal of the Ministry of Health and Family Welfare. This license specifically authorizes activities related to testing, evaluation, demonstration, and training. Following the application, the Ministry will issue the Test License in Form MD-13.
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Importance of the Test License for Medical Devices
Under India’s Medical Device Rule 2017, all medical devices, including those imported or manufactured in small quantities, require prior approval or registration. A test license is crucial to ensure that these devices are only used for specified purposes, not commercially. Given the significant impact medical devices have on patients’ health, a robust regulatory framework is necessary to ensure adherence to standards before market entry.
The test license is a vital part of India’s regulatory process, ensuring thorough testing of medical devices before commercialization. Without it, there’s a risk of unsafe or ineffective devices reaching the market, with potentially serious consequences. CDSCO aids manufacturers in obtaining test licenses, guiding them to meet regulatory standards, and ensuring the safety of medical devices for human use.
Process to Apply for a CDSCO Test License for Medical Devices
The applicant must adhere to the following procedure:
Step 1: Register the applicant on the Sugam portal.
Step 2: Prepare the draft application.
Step 3: Upload mandatory documents as per the MD-12 checklist.
Step 4: Complete the payment of the requisite government fee.
Step 5: Submit the application on the online medical device portal.
Documents Required to Test License for Medical Devices
- Brief description of the medical device, including intended use, material of construction, and design.
- Justification of the proposed quantity
- Test protocol/Approved clinical investigation plan
- Quality certificates such as QMS
- Labels and Instructions for Use (IFU)
- Undertaking stating the use of the medical device for non-commercial purposes.
- Undertaking from the testing laboratory confirming the provision of required facilities.
Applicable Fees:
- Test license for manufacture: Rs. 500 for each distinct medical device
- Test license for import: 100 USD for each distinct medical device
Validity:
The test license remains valid for 3 years from the date of issue.
Cancellation of Test License:
If a licensee contravenes any provisions of the rules, the Central Licensing Authority may issue a show cause notice for cancellation. The licensee has the right to appeal to the Central Government within forty-five days from the date of the cancellation order.
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Role of Operon Strategist to Get Test License for Medical Devices
Operon Strategist plays a pivotal role in simplifying the test license acquisition process for medical device manufacturers and importers in India. Through their expertise, diligence, and commitment to excellence, they ensure that clients navigate regulatory complexities with confidence and achieve timely test license approvals. As a trusted partner in regulatory compliance, Operon Strategist enables clients to focus on innovation and product development while ensuring adherence to the highest standards of regulatory compliance.
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