CDSCO Medical Device Registration for Pacemaker
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CDSCO Medical Device Registration for Pacemaker - Process, Documentation, Benefits acquired
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) regulates pharmaceuticals and medical devices, aligning its position 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 Pacemaker as a Medical Device?
A Pacemaker is a battery-powered small device that helps in preventing the heart from beating too slowly. A Pacemaker is also known as a Cardiac Pacing Device which is the size of a matchbox.
There are various types of Pacemakers; Single Chamber Pacemaker, Dual Chamber Pacemaker and Biventricular Pacemaker. The primary purpose of a pacemaker is to maintain an adequate heart rate.
Documents required in CDSCO Registration for Pacemaker as a Medical Device
Important documents required in the process are as follows:
- Application form MD 7
- Challan TR6
- ISO 13485
- Power of Attorney
- An Undertaking stating that only accurate information is provided
- Certificate of quality assurance
- C.E. Design accreditation
- Declaration of conformity
- Master Plant File
- Device Master File
- FSC
CDSCO Fee for Product
The taxvilla fee for the CDSCO certificate is INR 99,999/- only with taxvilla
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