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.
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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.
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
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.
Fill up the space with required details. Fill the ‘Registered Indian Address Form’ by providing the necessary personal and organizational details.
Complete the application process by submitting the required documents for the verification process which is done by CDSCO officials.
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.
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.
The benefits acquired after CDSCO registration for Pain Management Medical Devices can be seen as follows:
The Professional Fee For CDSCO import Certificate for Cosmetic products is INR 99,999/- only with Professional Utilities.
Important documents required in the process are as follows:
CDSCO Registration for Pain Management Medical Devices is a time taking process but you can contact Professional Utilities 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.
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Frequently Asked Questions
CDSCO stands for Central Drugs Standard Control Organisation.
CDSCO Registration is a process of obtaining approval from the regulatory authority to ensure the efficiency and quality of Pharmaceuticals, Medical Devices and Cosmetics.
SUGAM is the registration Portal of CDSCO.
A CDSCO Loan License for medical devices allows manufacturers to produce medical devices using another licensed manufacturing facility, as approved by CDSCO, while complying with the Medical Devices Rules, 2017.
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