CDSCO Registration for General Hospital Medical Devices
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CDSCO Registration for General Hospital Medical Devices - Procedure, Documents required
CDSCO, or the Central Drugs Standard Control Organisation, serves as the Indian National Regulatory Body for cosmetics, pharmaceuticals, and medical devices. It operates under the Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India.
In India, the import, manufacturing, sale, and distribution of drugs, medical devices, and cosmetics are regulated under the Drugs and Cosmetics Act of 1940 and its rules from 1945. CDSCO, along with state regulators, is responsible for granting licenses for specialized medical devices.
What are General Hospital Medical Devices?
General Hospital Devices and Supplies are those medical devices that health professionals use to support patients or for their own health and safety that are covered in the same category.
There are more than 50 General Hospital Medical Devices, some of them are; Hydraulic Adjustable Hospital Bed, Therapeutic Medical Blinder, Neonatal Eye Pad, Jet lavage etc.
Documents required for CDSCO Registration of General Hospital Medical Devices.
Important documents required in the process are as follows:
- Application Form MD 40
- Power of Attorney
- Certificate of quality assurance
- Challan TR6
- Plant-Master File
- ISO 13485 certificate
- An Undertaking declaring that the information stated is correct
- Device-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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