CDSCO Registration for Pain Management Medical Devices
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CDSCO Registration for Pain Management Medical Devices - Process, Documents
CDSCO, the Central Drugs Standard Control Organisation, is India’s National Regulatory Authority. Under the Drugs and Cosmetics Act of 1940 and Rules of 1945, these regulations categorize medicines into different schedules and provide guidelines for their storage, sale, display, and prescription.
It is essential to obtain CDSCO Registration for various types of Pain Management Medical Devices to operate under government regulations. CDSCO, along with state regulators, is responsible for granting licenses for certain specialized categories of drugs.
What are Pain Management Medical Devices?
Pain Management Medical Devices are devices that uses electrical signals to block pain sensation generated in the body. Some of the examples of Pain Management Medical Devices are Spinal Cord Stimulators, Transcutaneous, Electric nerve Stimulation devices etc are present in the market.
CDSCO Registration for Pain Management Medical Devices is a process of adhering to the rules of the regulatory body ‘CDSCO’ to work under legal compliance with no hindrances.
Benefits For CDSCO Registration for Pain Management Medical Devices.
The benefits acquired after CDSCO registration for Pain Management Medical Devices can be seen as follows:
- Ensuring Safety: The main aim of the Central Drugs Standard Control Organisation is to safeguard public health. The quality and efficiency of the device or product goes under a verification process done by the CDSCO officials. The safety and health issues of certain types of equipment are not a concern with registered Medical Devices as a finished product.
- Indian Market access: India has the largest Pharmaceuticals and medical device market in the world. CDSCO registration allows the manufacturers and importers to sell their products to the consumers in the Indian Market.
- Brand Recognition: CDSCO registration enhances the manufacturer’s brand recognition and credibility, as it demonstrates that the products have met rigorous safety, efficacy, and quality standards.
Documents For CDSCO Registration for Pain Management Medical Devices
mportant documents required in the process are as follows:
- Form MD 27
- ISO Certificate-13485
- Quality Assurance Certificate
- Plant Master Report
- Device Master File
- Performance Evaluation Report of the Device
- FSC Certificate
- Undertaking from Government Authority
CDSCO Fee for Product
The fee for a CDSCO import certificate for cosmetic products is INR 99,999/- only with Taxvilla.