CDSCO Registration for Pain Management Medical Devices - Process, Documents
CDSCO is the National Regulatory Authority of India referring to the Central Drugs Standard Control Organisation. Under the Drugs and Cosmetics Act 1940 and Rules 1945, these rules classify medicines into different schedules and provide guidelines for their storage, sale, display and prescription.
It is mandatory to do CDSCO Registration for the various types of Pain Management Medical Devices to work under government regulations. CDSCO with state regulators are responsible for grant of licenses of 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.
What is CDSCO Registration for Pain Management Medical Devices
CDSCO Registration for Pain Management Medical Devices is a process of obtaining a formal approval from the regulatory body ‘CDSCO’ to deal with it in various activities as the sale, manufacturing and distribution of medical devices are regulated under CDSCO in India.
Within the CDSCO, the Drug Controller General of India (DCGI) regulates Pharmaceuticals & Medical Devices and its positioning with the Ministry of Health and Family Welfare.
Process for CDSCO Registration for Pain Management Medical Devices
Process For CDSCO Registration for Pain Management Medical Devices
Step 1:SUGAM Portal
You need to visit the ‘SUGAM’ registration portal on the official website of CDSCO. Click on the ‘sign up here’ option to start the registration process.
Step 2:Filling up the Form
Fill up the space with required details. Fill the ‘Registered Indian Address Form’ by providing the necessary personal and organizational details.
Step 3:Documentation
Complete the application process by submitting the required documents for the verification process which is done by CDSCO officials.
Step 4:Confirmation of registration
A confirmation link will be sent to the registered email Id to verify the registration. Click on the link to activate the account on CDSCO-portal.
Step 5:Approval from the officials
Once the confirmation link is clicked, the application for registration will be sent to the concerned authority for an approval after the verification of the formal documents.
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.
CDSCO Fee for Product
The Professional Fee For CDSCO import Certificate for Cosmetic products is INR 99,999/- only with Monitrix.
Documents For CDSCO Registration for Pain Management Medical Devices
Important 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
Conclusion
CDSCO Registration for Pain Management Medical Devices is a time taking process but you can contact Monitrix for the same to access benefits and for working under legal compliance with whole terms and conditions in order to build brand’s reputation, ensuring safety, safeguard public health etc.