Integral CDSCO License for Self-Testing IVDs in India
Welcome to MedDev Experts
Your trusted partner for expedited CDSCO license and registration for Self-Testing In-Vitro Diagnostic Medical Devices (IVDs).
Are you a manufacturer or importer of Self-Testing IVDs? The self-testing kits and regents are categorized as in-vitro diagnostic medical devices (IVDs) and are regulated by the Medical Device Rules, 2017.
To manufacture, import, sell, or distribute self-testing IVDs in India, you need a medical device license (MD 5, MD 9, MD 15, or MD 42). This applies to all self-testing kits including Human Chorionic Gonadotropin (hCG), Luteinizing Hormone, Glucose, Glycosylated hemoglobinor its variants, Cholesterol, Follicle Stimulating Hormone (FSH) and Other In-Vitro Diagnostic Medical Devices for Self-Testing.
List of Self-Testing IVDs Classified as “Class B” by the CDSCO
- Glucose test reagents/kits: Intended for the preliminary self-testing of glucose levels in blood/body fluids.
- Human Chorionic Gonadotropin (hCG) test reagent/kit: Intended for the preliminary self-testing of hCG in urine/body fluids.
- Luteinizing Hormone (LH) test reagents/kits: Intended for the preliminary self-testing of Luteinizing Hormone (LH) in urine/body fluids.
- Glycosylated Hemoglobin or its variants test reagents/kits: Intended for preliminary self-testing of Glycosylated Hemoglobin or its variants including A1a, A1b, and A1c in blood.
- Cholesterol test reagents/kits: Intended for preliminary self-testing of cholesterol in blood /body fluids.
- Follicle Stimulating Hormone (FSH) test reagent/kit: Intended for the preliminary self-testing of Follicle Stimulating Hormone (FSH) in urine /body fluids
- Other In-Vitro Diagnostic Medical Devices for Self-Testing
Why is CDSCO licensing important?
A CDSCO license for your Self-Testing IVDs is not just a legal requirement; it is a commitment to quality and patient safety. It demonstrates that your products meet the highest standards and are ready to contribute to accurate medical diagnoses and patient care.
At MedDev Experts, we make the licensing process easy so you can focus on what you do best: innovating and providing high-quality diagnostic solutions.
Contact MedDev Experts Today for Your CDSCO License and Registration
Don’t let regulatory hurdles slow you down. Get in touch with MedDev Experts today and let us help you secure your CDSCO License for Self-Testing In-Vitro Diagnostic Medical Devices (IVDs). Our team of experts will guide you through the process, ensuring a seamless experience.
Join hands with us to make a difference in healthcare. Together, we can bring your products to market swiftly and safely, ensuring they reach those who need them most.
How MedDev Experts Helps You Get Your CDSCO License
MedDev Experts is a team of experienced professionals who can help you get your CDSCO license for Self-Testing IVDs. We offer a wide range of services, including:
- Regulatory expertise: We can help you navigate the complex CDSCO regulatory landscape
- Documentation assistance: We can help you prepare and submit the required documentation
- Quality assurance: We can help you implement and maintain robust quality systems in accordance with ISO 13485:2026.
- Risk assessment: We can help you identify and mitigate risks associated with your product
- Product testing: We can help you coordinate and conduct the necessary product testing
- Customized solutions: We tailor our services to your specific needs
- Timely approvals: We can help you get your license quickly and efficiently
- Continuous support: We provide ongoing support to ensure you remain compliant with regulatory changes