CDSCO Medical Device Registration for IVD Lab Kit
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CDSCO Medical Device Registration for IVD Lab Kits - Meaning, Procedure, Importance
The Central Drugs Standard Control Organisation (CDSCO) is India’s National Regulatory Authority and a highly influential organization in the country. It operates under the Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India.
Within the CDSCO, the Drug Controller General of India (DCGI) oversees pharmaceuticals and medical devices and their regulation. CDSCO is responsible for approving new drugs and issuing licenses in accordance with the Drugs and Cosmetics Rules, 1945.
What are IVD Lab Kits?
IVD, or In Vitro Diagnostics, are medical devices used to test human samples for identifying diseases, disorders, and infections. These tests are performed on samples taken from the body, such as swabs or blood, and can help diagnose, treat, or prevent diseases.
Importance of CDSCO Medical Device Registration
CDSCO registration for IVD lab kits offers several benefits:
Regulatory Compliance: CDSCO registration ensures compliance with relevant laws and regulations, aiming to protect public health.
Safety & Quality: It ensures that medical devices are free from harmful substances and are safe for use by the public.
Market Access: CDSCO registration is necessary for dealing with drugs and medical devices, opening up new market opportunities.
Documents For CDSCO Registration for IVD Lab Kits
Documents required in CDSCO Registration for IVD Lab Kits are as follows:
- 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 Company
- Plant Master File
- Device Master File
- FSC (Free Sale Certificate)
- PMS Report (Post-Market Surveillance Report)
- Performance Evaluation Report of Products
- Original labels and pack sizes
CDSCO Fee for Product
The taxvilla fee for the CDSCO certificate is INR 99,999/- only with taxvilla
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