CDSCO Registration for Defibrillators
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CDSCO Medical Devices Registration for Defibrillators - Process, Fee, Documentation
The Central Drugs Standard Control Organisation is one of the powerful organizations in India. CDSCO is India’s National Regulatory Body for Cosmetics, Pharmaceuticals and Medical Devices.
Within the CDSCO, the Drug Controller General of India (DCGI) regulates pharmaceuticals and medical devices and its positioning with the Ministry of Health and Family Welfare.
What is a Defibrillators Medical Device?
A defibrillator is a medical device that delivers an electric shock to the heart to restore or correct a normal heartbeat. It is used to treat life-threatening conditions that affect the heart’s rhythm, such as ventricular fibrillation and ventricular tachycardia.
There are various types of defibrillators, including automated external defibrillators (AEDs), implanted cardioverter defibrillators (ICDs), and wearable cardioverter defibrillators (WCDs), all of which require CDSCO registration.
Documents required in the CDSCO for Defibrillators process
Documents required in the process are listed below;
- Form MD 40
- ISO Certificate-13845
- Fee Challan
- Power of Attorney
- Quality Assurance Certificate
- Device Master File
- Plant Master File
- FSC (Free Sale Certificate)
- Details and Address Proof of the Applicant
- Medical Device Description
CDSCO Fee for Product
The taxvilla fee for the CDSCO certificate is INR 99,999/- only with taxvilla
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