Before medical devices hit the market in India, manufacturers need a Test License for clinical testing. Bioexcel Lifesciences can guide you through the entire process seamlessly.

Understanding the Test License: Forms MD-12 and MD-13

What is a Test License?

A Test License is required for manufacturers who intend to produce medical devices for testing, validation, examination, or clinical investigation. This license is not meant for commercial production but strictly for evaluating the safety, performance, and effectiveness of the device. This is a critical step before any device can be marketed and used on patients.

Form MD-12: Application for Test License

The process starts with Form MD-12, which is the application for obtaining a test license. Manufacturers must provide detailed information about the device they wish to manufacture, including:

• Description of the device: Specifications, intended use, and classification.
• Purpose of manufacture: Whether it’s for internal testing, validation, or clinical trials.
• Facility details: Information about the premises where the device will be manufactured.

The application must show that the device is intended for testing and clinical evaluation. It should align with the regulatory framework set by the Medical Devices Rules, 2017.

Form MD-13: Issuance of the Test License

After the application is approved, the manufacturer receives Form MD-13. This form acts as the license to produce the specified devices. The scope of this license is limited to the purposes outlined in Form MD-12, with no permission for commercial distribution. The license comes with specific conditions, such as:

• Manufacturing is restricted to the quantities required for testing and investigation.
• Adherence to strict regulatory and quality standards during the production process.
• Regular reporting and oversight as mandated by the Central Drugs Standard Control Organization (CDSCO).

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.

Why is a Test License Important?

• Compliance: It ensures that all testing and clinical trials of medical devices are conducted in a controlled and regulated environment.
• Safety and Efficacy: Manufacturers can test the performance and safety of the device before mass production, thus reducing risks and ensuring patient safety.
• Market Readiness: Obtaining the Test License is a crucial step toward bringing the device to market, as it helps meet regulatory standards required for full market approval.

How Bioexcel Lifesciences Can Help

Navigating the regulatory landscape of medical devices can be complex and time-consuming. At Bioexcel Lifesciences and Research, we specialize in helping medical device companies streamline their compliance efforts, ensuring smooth progression from device conception to market launch.

Our Services Include:

1. Regulatory Strategy and Consulting: Our team of regulatory experts provides strategic guidance tailored to your device, ensuring compliance with Indian regulations such as the Medical Devices Rules, 2017. We help you understand the requirements for obtaining a Test License and support you throughout the application process.
2. Preparation of Form MD-12: We assist in preparing and submitting Form MD-12, ensuring all necessary details about the device, manufacturing facility, and testing purposes are accurately represented to the regulatory authorities.
3. Liaison with CDSCO: We act as your liaison with the Central Drugs Standard Control Organization, managing communications and addressing any queries or additional documentation requests that may arise during the approval process.
4. Post-License Support: After obtaining your test license via Form MD-13, we provide ongoing support to ensure compliance with all conditions set by the regulatory authorities. This includes assistance with regular reporting, documentation of testing outcomes, and ensuring quality control standards are met throughout the testing phase.
5. Clinical Trial Management: If your device is intended for clinical trials, we offer end-to-end support for clinical investigations, from study design and protocol development to trial management and reporting, ensuring that the clinical data generated is robust and regulatory-compliant.

Why Choose Bioexcel Lifesciences?

With extensive experience in regulatory affairs and a deep understanding of the Medical Device Rules and global standards, Bioexcel Lifesciences is your trusted partner in bringing medical devices to market. Whether you are developing a Class A low-risk device or a Class D high-risk implant, we provide the expertise needed to navigate the regulatory challenges and ensure your device is safe, effective, and compliant with all relevant regulations.

Validity

The validity for the Test License is 3 Years

Conclusion

Obtaining a Test License to manufacture medical devices for testing or clinical investigation is a critical step in the product development process. Understanding the intricacies of Forms MD-12 and MD-13 and adhering to India’s regulatory standards can be challenging, but with the right partner, it becomes much simpler. At Bioexcel Lifesciences, we provide end-to-end support, from preparing your application to ensuring full compliance with CDSCO requirements.

If you’re looking to bring a new medical device to the Indian market, contact us today to learn more about how we can assist you in navigating the regulatory process efficiently and effectively.