CDSCO Medical Device Registration for Nebulizer
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CDSCO Medical Device Registration for Nebulizer - Process, Documentation, Fee
The Central Drugs Standard and Control Organisation (CDSCO) is India’s National Regulatory Authority for cosmetics, pharmaceuticals, and medical devices, making it a highly influential organization in the country.
Within the CDSCO, the Drug Controller General of India (DCGI) oversees the regulation of pharmaceuticals and medical devices and its alignment with the Ministry of Health and Family Welfare. The import, manufacturing, sale, and distribution of drugs in India are regulated under the Drugs and Cosmetics Act of 1940 and Rules of 1945.
What is a Nebulizer as a Medical Device?
A nebulizer, also known as an atomizer, is a medical device that converts liquid medicine into a mist or aerosol. This mist is inhaled directly into the lungs to treat respiratory conditions.
Documents For CDSCO Medical Devices Registration for Nebulizer
Important documents required in the process are as follows:
- Application form (Form 40)
- TR6 Challan
- ISO 13485 Certificate
- Power of attorney
- The undertaking of authentic details
- CE design certificate
- Full quality assurance certificate
- Declaration of conformity
- Schedule D(I)
- Device Master File
- Plant Master File
- Free Sale Certificate
CDSCO Fee for Product
The taxvilla fee for the CDSCO certificate is INR 99,999/- only with taxvilla
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