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Test License MD 13 - Empowering manufacturers of medical devices in India with state-of-the-art testing capabilities through a Medical Device Test License.

Medical Device Test License - MD-12 & 13

In India, the regulation of all medical devices falls under the Medical Device Rule of 2017. This regulation includes provisions enabling manufacturers to produce limited quantities of medical devices for various purposes such as clinical investigations, tests, evaluations, examinations, demonstrations, or training. This authorization is commonly referred to as the Medical Device Test License, denoted as MD-13.

The MD-13 license serves as a significant asset for medical device manufacturers in India, facilitating the development and evaluation of medical devices under controlled conditions. This provision fosters innovation, ensures quality control, and drives progress in healthcare practices.

By leveraging the MD-13 license, manufacturers can gather valuable insights into their device performance and validate the safety and effectiveness of their products to regulatory bodies. Such initiatives contribute to enhancing the quality of medical devices and ultimately improving patient care standards across India.

Quick navigation for Medical Device Test License - MD-13

Test license for Manufacturing

When there is a requirement of small quantity of Class A or Class B or Class C or Class D of medical devices for the purpose of test, evaluation, examination, clinical investigations, demonstration or training.

  • Form MD-12:
    The application for the test license for manufacturing devices is to be made in Form- MD 12 to the central licensing authority i.e. CDSCO also known as Indian FDA, accompanied with fees.

  • Form MD-13:
    The CDSCO shall review the test license application and shall grant a test license in Form MD-13 or CDSCO may reject the application if it is not satisfied with the submitted documentation.

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Advantages of the Medical Device Test License - MD-13

  • 1. Enables manufacturers to create and evaluate medical devices under controlled conditions.

  • 2. Encourages innovation, ensures quality control, and drives healthcare advancements.

  • 3. Facilitates manufacturers in receiving performance feedback on their devices.

  • 4. Validates the safety and effectiveness of medical devices to regulatory bodies.

  • 5. Has the potential to enhance medical devices and patient care.

As a medical device manufacturer in India, securing the MD-13 license is a strategic move worth considering. This license can serve as a pivotal asset, aiding in elevating the quality standards of your products while ensuring their safety and effectiveness for patients.

Licensing Authority

The Central Drugs Standard Control Organization (CDSCO) acts as the regulatory authority tasked with overseeing and issuing the Medical Device Test License MD-13 within India. This license empowers medical device manufacturers to conduct essential trials and assessments in compliance with established regulations.

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The stipulations of the CDSCO Test License MD-13

  • License Usage: The licensee must utilize the license solely for activities such as clinical investigations, tests, evaluations, examinations, demonstrations, or training, as specified in the license and at the designated location.

  • Premises Accessibility: The licensee is obliged to permit the Medical Device Officer to enter the premises, with or without prior notice, to ensure that only authorized activities such as clinical investigations, tests, evaluations, examinations, demonstrations, or training are being conducted.

  • Record Maintenance: The licensee is required to keep records detailing the quantity of manufactured, tested, and stocked medical devices, along with their disposition.

Terms of the CDSCO Test License MD-13:

The Central Drugs Standard Control Organization (CDSCO) acts as the regulatory authority tasked with overseeing and issuing the Medical Device Test License MD-13 within India. This license empowers medical device manufacturers to conduct essential trials and assessments in compliance with established regulations.

  • License Usage: The licensee must utilize the license solely for activities such as clinical investigations, tests, evaluations, examinations, demonstrations, or training, as specified in the license and at the designated location.

  • Premises Accessibility: The licensee is obliged to permit the Medical Device Officer to enter the premises, with or without prior notice, to ensure that only authorized activities such as clinical investigations, tests, evaluations, examinations, demonstrations, or training are being conducted.

  • Record Maintenance: The licensee is required to keep records detailing the quantity of manufactured, tested, and stocked medical devices, along with their disposition.

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Documentation Needed for Obtaining Medical Device Test License MD-13:

  • Application Submission: Manufacturer submits the application for MD-13 license to CDSCO.

  • Documentation Review: CDSCO reviews the application and required documents.

  • Documentation Verification: CDSCO verifies the submitted documents for completeness and accuracy.

  • Compliance Assessment: CDSCO ensures that the applicant complies with regulatory requirements and guidelines.

  • License Issuance: Upon successful verification and compliance assessment, CDSCO issues the MD-13 license to the manufacturer.

  • License Utilization: Manufacturer utilizes the MD-13 license exclusively for approved activities such as clinical investigations, tests, evaluations, examinations, demonstrations, or training.

  • Regulatory Oversight: CDSCO may conduct periodic inspections to ensure compliance with the terms of the MD-13 license.

The procedure for acquiring the Medical Device Test License MD-13:

Here's a process map outlining the steps to obtain the Medical Device Test License MD-13:

  • Application Submission: Manufacturer submits an application for MD-13 license to CDSCO.

  • Document Review:CDSCO reviews the submitted application and required documents.

  • Compliance Check:CDSCO ensures that the application complies with regulatory standards and guidelines.

  • Verification of Documents:CDSCO verifies the authenticity and completeness of the submitted documents.

  • Assessment:CDSCO evaluates the application to determine eligibility for the MD-13 license.

  • Approval/Rejection:CDSCO notifies the manufacturer of the approval or rejection of the MD-13 license application.

  • Issuance of License:If approved, CDSCO issues the MD-13 license to the manufacturer.

  • License Utilization:The manufacturer utilizes the MD-13 license exclusively for authorized activities such as clinical investigations, tests, evaluations, examinations, demonstrations, or training.

  • Compliance Monitoring:CDSCO may conduct periodic inspections to ensure compliance with the terms of the MD-13 license.

Fees of the CDSCO Test License MD-13

The charges associated with the CDSCO Test License MD-13 can vary and are typically determined by the regulatory authority based on factors such as the type of medical devices involved, the scope of activities permitted under the license, and any additional services provided by the authority.

The applicant has to pay ₹ 500/- for each distinct Medical Device for the test license MD-42.

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Duration of Validity for the CDSCO Test License MD-13

The Medical Device Test License maintains its validity for a duration of three years starting from the date it is issued by the regulatory authority. However, it's essential to note that the license can be terminated before the end of this period if any breaches of regulatory rules occur.

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