MedDev Experts



Clinical Chemistry Reagents or Kits CDSCO License in 60 Days: Fast, Easy, and Affordable

Welcome to MedDev Experts

Your trusted partner for expedited CDSCO license and registration for clinical chemistry reagents or kits.

Are you a manufacturer or importer of clinical chemistry reagents or kits? These reagents and kits are categorized as in-vitro diagnostic medical devices (IVDs) and are regulated by the Medical Device Rules, 2017.

To manufacture, import, sell, or distribute IVDs in India, you need a medical device license (MD 5, MD 9, MD 15, or MD 42). This applies to all critical diagnostic tests, including albumin, ammonia, amylase, cholesterol, creatinine, glucose, hemoglobin, iron, triglycerides, and uric acid tests.

List of Clinical Chemistry Reagents or Kits Classified as “Class B” by the CDSCO

  • Acid Phosphatase (total or prostatic) test reagents/kits
  • Albumin test reagents/kits
  • Alkaline phosphatase or isoenzymes test reagents/kits
  • Ammonia test reagents/kits
  • Amylase test reagents/kits
  • Bicarbonate/carbon dioxide test reagents/kits
  • bilirubin (total and direct) test reagents/kits
  • Calcium test reagents/kits
  • Chloride test reagents/kits
  • Cholesterol (total) test reagents/kits
  • HDL cholesterol test reagents/kits
  • LDL cholesterol test reagents/kits
  • Lipoproteins test reagents/kits
  • Cholinesterase test reagents/kits
  • Creatine Kinase and its isoenzymes test reagents/kits
  • Copper test reagents/kits
  • Creatinine test reagents/kits
  • Gamma Glutamyl Transferase (GGT) and isoenymes test reagents/kits
  • Glucose test reagents/kits
  • Glucose-6-Phosphate Dehydrogenase (G6PD) and its isoenzymes test reagents/kits
  • Glycosylated Hemoglobin or its variants test reagents/kits
  • Hemoglobin test reagents/kits
  • Iron test reagents/kits
  • Ferritin test reagents/kits
  • Iron-binding capacity test reagents/kits
  • Lactate Dehydrogenase and its isoenzymes test reagents/kits
  • Lipase test reagents/kits
  • Magnesium test reagents/kits
  • Phosphorus (inorganic) test reagents/kits
  • Potassium test reagents/kits
  • Aspartate Amino Transferase (AST/SGOT) test reagents/kits
  • Alanine Amino Transferase (ALT/SGPT) test reagents/kits
  • Sodium test reagents/kits
  • Total protein test reagents/kits
  • Protein (fractionation) test reagents/kits
  • Protein-bound iodine test reagents/kits
  • Triglycerides test reagents/kits
  • Urea (BUN) test reagents/kits
  • Uric Acid test reagents/kits
  • Micro-Protein test reagents/kits
  • Zinc test reagents/kits
  • Other clinical chemistry test reagents/kits
  • Blood cell Diluents
  • Lyse reagents/kits for differential counts
  • Rinse/Detergent/Cleaners reagents/kits

Why is CDSCO licensing important?

A CDSCO license for your clinical chemistry reagents or kits 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 Clinical Chemistry Reagents or Kits. 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 clinical chemistry reagents or kits. 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
Scroll to Top