CDSCO Registration for IVD Lab Kits

The Central Drugs Standard Control Organisation (CDSCO) serves as India's primary National Regulatory Authority, operating under the Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India.

At the core of CDSCO's responsibilities is the Drug Controller General of India (DCGI), overseeing the regulation of pharmaceuticals and medical devices. CDSCO plays a pivotal role in approving new drugs and issuing licenses in accordance with the Drugs and Cosmetics Rules of 1945.

What are In Vitro Diagnostic (IVD) Laboratory Kits?

IVD refers to In Vitro Diagnostic medical devices utilized for testing human samples. These tests are designed to identify diseases, disorders, and infections.

In vitro diagnostic (IVD) devices are tests conducted on samples obtained from the human body, including mucus swabs from the nose or throat, or blood from veins or finger pricks. These devices detect diseases and conditions, aiding in the monitoring of health for prevention, treatment, or cure purposes.

What does CDSCO Registration entail for IVD Laboratory Kits?

In India, the production, importation, and sale of IVD Lab Kits are categorized under drug regulations. CDSCO Registration for IVD Lab Kits involves obtaining a manufacturing license for IVD Medical Devices. This license permits manufacturers to engage in activities such as manufacturing, importing, conducting clinical evaluations, selling, and distributing IVD Medical Devices or Lab Kits within India.

IVD Medical Devices are classified into various categories according to their risk levels, such as:

Class A - Low Risk
Class B - Moderate Low Risk
Class C - Moderate High Risk
Class D - High Risk

Steps for CDSCO Registration of Medical Devices for IVD Lab Kits

Online Registration: Visit the official CDSCO website and access the 'SUGAM CDSCO Portal.' Click on the 'SIGN UP HERE' option to start your application.
Fill Out the Details:The registration form is divided into two sections: 'Applicant Details,' where you provide your personal information, and 'Registered Indian Address,' where you input your organization's details.
Document Submission: Complete the application by submitting all required documents for verification.
Verification of Registration :A confirmation link will be emailed to your registered address. Click on the link to activate your account on the SUGAM portal.
Approval from Authority: Once you confirm your registration, your application will be forwarded to the relevant authority for approval. If approved by CDSCO officials, you will receive an approval email. If rejected, you will be notified accordingly.
License Issuance: Following thorough verification of your submitted documents, your application will undergo assessment. Upon satisfactory completion, your registration will be approved and a license issued accordingly.

Significance of CDSCO Registration for Medical Devices

CDSCO registration for IVD Lab Kits carries multiple

Regulatory Adherence: CDSCO Registration ensures compliance with applicable laws and regulations, aiming to protect public health.
Product Safety & Quality Assurance: CDSCO registration verifies that medical devices are free from harmful substances and meet safety standards, ensuring they are suitable for widespread use.
Market Entry Facilitation: CDSCO Registration is essential for market entry of drugs and medical devices, ensuring they are safe and meet regulatory standards, thus creating new market opportunities.

Required Documents for CDSCO Registration of IVD Lab Kits

The following documents are essential for the CDSCO registration process for a IVD Lab Kits:

Power of Attorney
Details according to Annexure B (HIV, HBV, HCV, and Blood Grouping Sara)
TR6 Challan
Wholesale Drug License
ISO Certificate-13485
CE Design Certificate
Complete Quality Assurance Certificate
Declaration of conformity
Master Plant File
Device Master File
FSC
Plant Master File
Performance Evaluation Report of Products
Performance Evaluation Report of Products

Conclusion

CDSCO is committed to enhancing transparency, accountability, and consistency in its operations to safeguard the safety, efficiency, and quality of medical products and kits manufactured, imported, and distributed in India. Obtaining a manufacturing license for IVD Lab Kits is mandatory for manufacturers to engage in the production, importation, clinical evaluations, sale, and distribution of IVD medical devices or lab kits within the country.

Frequently asked questions (FAQ)

What are IVDs?

IVDs refer to In Vitro Diagnostics medical devices used for testing human samples.

What is CDSCO Registration?

CDSCO Registration is the formal process of obtaining approval from the regulatory authority to ensure the efficiency and quality of pharmaceuticals, medical devices, and cosmetics.

What is the process for CDSCO Registration of IVD Medical Devices?

The process includes accessing the CDSCO registration portal, providing required details, submitting necessary documents, confirming registration via email, obtaining approval from the regulatory authority, and receiving the license.