Clinical chemistry reagents and kits are considered in-vitro diagnostic devices (IVDs) per CDSCO guidelines. They are regulated by the Medical Device Rules, 2017. To manufacture or import clinical chemistry reagents and kits, you need to comply with CDSCO regulations for IVDs. Additionally, you need to secure the manufacturing/import license (as applicable) for clinical chemistry reagents. We at Pharmadocx Consultants will help you easily secure the CDSCO license for clinical chemistry reagents.
What are clinical chemistry reagents?
Clinical chemistry reagents are products used in laboratory settings to detect and quantify specific substances in biological samples, such as blood and urine. They are used to measure various biomarkers, such as glucose, electrolytes, albumin, urea, and enzymes. The reagents are crucial for accurate diagnosing and monitoring various medical conditions. Hence, clinical chemistry reagents play a vital role in patient care by providing valuable insights into the patient’s health status.
CDSCO license for clinical chemistry reagents
Given the role clinical chemistry reagents play in patient diagnosis and treatment monitoring, they are strictly regulated under the IVD category in India. Hence, securing the CDSCO license for clinical chemistry reagents is a mandatory requirement to sell your product in India. Although having the CDSCO clinical chemistry reagent license is a regulatory requirement, the license is beneficial for the manufacturer/importer as well. The license demonstrates commitment to quality and patient safety. Additionally, it indicates the product meets the highest standards as well as can be used to effectively and accurately diagnose medical conditions.
As clinical chemistry reagents have been categorised as IVDs, they will have to follow the CDSCO IVD regulations. CDSCO has categorised IVDs into four classes for ease of registration and licensing. The CDSCO IVD classification system is based on the level of risk associated with the device. Each CDSCO IVD class has its own license requirements.
CDSCO class for clinical chemistry reagents
Clinical chemistry reagents mostly belong to CDSCO class A and B. We have provided some examples.
Class A
- Diluents
- Lysing reagents
- Rinse/detergent/cleaners
- Electrolyte reagents
Class B
- Alkaline phosphatase or isoenzymes test reagents/kits
- Ammonia test reagents/kits
- Amylase test reagents/kits
- Bicarbonate/carbon dioxide test reagents/kits
- Hemoglobin test reagents/kits
- Iron 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
- Uric Acid test reagents/kits
- Micro-Protein test reagents/kits
- Zinc test reagents/kits
Securing CDSCO license for clinical chemistry reagents
CDSCO manufacturing license for clinical chemistry reagents
- Manufacturing license for clinical chemistry reagents: The CDSCO license for manufacturing clinical chemistry reagents is MD 5. The applicant will have to use MD 3 to apply for a license to manufacture, sell, and distribute clinical chemistry reagents in India. The license to manufacture clinical chemistry reagents for sale and distribution in India will be granted under MD 5.
- Loan license: A loan license permits a company without a manufacturing facility to manufacture IVDs. With the loan license, the company can use the manufacturing facility of another company that is manufacturing the same product. The applicant will have to use MD 4 to apply for a loan license for clinical chemistry reagents. The loan license to manufacture the reagents without a manufacturing facility will be granted under MD 6.
Supporting documents for manufacturing license for clinical chemistry reagents
- Cover letter
- Organization identity proof, such as UDYAM Aadhar, PAN card, etc.
- Sale Deed/Rent Deed proving legal ownership of the manufacturing facility.
- Facility building layout presenting the dimensions of each room and the location of all the equipment in the manufacturing facility.
- Plant master file
- Device master file
- Audit reports
- ISO 13485 Certificate validating the manufacturing facility meets international criteria for quality management systems.
- Certificate of analysis of 3 consecutive batches to certify the first 3 batches of the manufactured devices meet the required quality benchmarks.
- Test license (if applicable)
- In case of loan license application, consent letter from the principal manufacturing unit, principal manufacturer’s license and product permit, and wholesale license of the applicant.
- Documents proving the manufacturing team comprises competent, qualified, and experienced staff who will manufacture and test the devices.
- Document supporting compliance with the environmental regulatory requirements.
CDSCO import license for clinical chemistry reagents
To import clinical chemistry reagents into India, the CDSCO MD 15 import license will be required. An application has to be filed under Form MD 14. The license for importing the reagents for sale and distribution in India will be granted under CDSCO MD 15.
Supporting documents for import license for clinical chemistry reagents
- Notarized copy of overseas manufacturing site or plant registration in the country of origin issued by the competent authority.
- Self-attested copy of valid manufacturing license demonstrating the device is manufactured in accordance with the regulatory requirements of the country of origin.
- Plant master file
- Device master file
- Notarized copy of ISO 13485 certificate of the actual IVD manufacturer
- Duly apostilled/notarized copy of Free Sale Certificate from National Regulatory Authority of country of origin
- Full Quality Assurance Certificate/CE type examination certificate/CE product quality assurance certificate
- Notarized Declaration of Conformity stating the device complies with applicable regulatory requirements and standards
- Notarized CE design certificate
- A copy of the latest inspection or audit report carried out by Notified bodies or the National Regulatory Authority within last 3 years
- Power of attorney, in case an authorized agent has to be appointed
- Constitution details of Indian authorized agent for foreign IVD manufacturers
A step-by-step guide to license application
- Applicant registration: Register on the official CDSCO online portal, SUGAM.
- Document preparation: Prepare and compile all necessary supporting documents per CDSCO guidelines.
- CDSCO clinical chemistry reagent license application: Fill in the applicable application form (MD 3, MD 4, or MD 14) with all the required details. Ensure accuracy and completeness.
- Online submission: Upload the duly filed in application form along with the necessary documents on the online portal. Next, pay the necessary fees for the CDSCO clinical chemistry reagent license application. Once you have successfully completed all the steps and submitted your application, you will receive an application number.
- CDSCO application review: The CDSCO will review the application for compliance with regulatory guidelines and verify the documents. They will check for any areas of non-conformities.
- CDSCO query response: CDSCO officials may raise queries asking for additional clarification and further documentation. It is important to promptly and appropriately respond to all queries. Response should be provided in a timely manner along with additional documents (if required) to support the response.
- Facility inspection and audit: The CDSCO may inspect the facility to verify whether it meets all applicable quality and regulatory standards. CDSCO audits are conducted for ensuring regulatory compliance.
- License approval and grant: CDSCO will evaluate all the information provided and check the response to the queries. If satisfied, they will approve the application. The CDSCO license for clinical chemistry reagents will be granted. This license will permit you to manufacture or import (as applicable) the clinical chemistry reagent specified in your application for sale and distribution in India.
Pharmadocx Consultants: Your trusted regulatory consultant
With over 27 years of experience and more than 600 clients, the Pharmadocx Consultants team has extensive knowledge of the CDSCO regulations. Be it CDSCO manufacturing or import license, we have got you covered. We will leverage our expertise and industry knowledge to help you easily secure the CDSCO clinical chemistry reagent license. We offer the following services:
- Document preparation
- Application filing
- Implementation of QMS
- Mock audit service
- Acting as a liaison between you and CDSCO officials
- CDSCO query response
- Post license support
- Authorised agent service
Email at [email protected] or call/Whatsapp on 9996859227 and we will help you easily secure the CDSCO license for clinical chemistry reagents in India.
