CDSCO registration for Cardiovascular Medical Devices
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CDSCO registration for Cardiovascular Medical Devices - Meaning, Process, Fee
CDSCO, or the Central Drugs Standard Control Organisation, is India’s national regulatory body for cardiovascular medical devices, 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 cardiovascular medical devices are regulated under the Drugs and Cardiovascular Medical Devices Act 1940 and Rules 1945. CDSCO, along with state regulators, is responsible for granting licenses for specialized medical devices.
What are Cardiovascular Medical Devices?
A Cardiovascular Medical Device is a small device that has wires which are implanted in the heart tissue such as artificial heart waves, coronary stents, angioplasty balloon catheters etc to improve the quality of life of millions of people.
These are Implanted electronic devices that helps to control or monitor irregular heartbeat. There are different types of cardiovascular medical devices based on different requirements referring to the circulatory system.
Documents For CDSCO Registration for Cardiovascular Medical Devices
Documents required in CDSCO Registration are as follows:
- Covering Letter.
- Form MD 40
- Challan TR6
- ISO Certificate-13485
- Power of Attorney
- Covering Letter
- Device Master File
- Plant Master File
- Declaration of Conformity
- Certificate of Quality Assurance
CDSCO Fee for Product
The fee for the CDSCO import certificate for cosmetic products is INR 99,999/- only with taxvilla.
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