Updated on July 06, 2024 06:14:04 PM
CDSCO is a highly powerful Organisation in India referring to the Central Drugs Standard Control Organisation. It is the National Regulatory Body for Cosmetics, Pharmaceuticals and Medical Devices.
As the Indian Government has announced its plan to bring all medical devices, including implants and contraceptives under a review of CDSCO, Thus it is mandatory to hold a CDSCO Certificate after registration by the Individuals dealing with Ophthalmic Medical Devices in the domain.
Ophthalmic Medical Devices are devices that fulfill a medical purpose to use in Optometry and Ophthalmology. These devices are designed to treat and prevent eye damage, disease or Injuries.
There are various types of Ophthalmic Medical devices that needs to be registered with CDSCO in order to comply with the latest Medical Devices Rules in India, these are the legal framework for regulating the import, manufacture, distribution and sale of the medical devices, drugs and cosmetics in India under the Drugs and Cosmetics Act 1940 and Rules 1945.
CDSCO, the Central Drugs Standard Control Organisation, comes under the Directorate General of Health Services, Ministry of Health and Family Welfare and Government of India. Under the Drugs and Cosmetics Act, CDSCO is responsible for various activities of drugs, medical devices and cosmetics.
CDSCO registration for Ophthalmic Medical Devices is a process of obtaining approval from the regulatory authority to ensure the efficiency and quality of the devices, accomplishing their main aim that is to safeguard public health.
We can consider following steps of CDSCO registration for Ophthalmic Medical Devices;
You need to Login/Sign Up on the registration portal which is ‘SUGAM’ on the official website of CDSCO.
By clicking on the ‘Sign Up here’ option, the Registration purpose page will open. Select the ‘Registration Purpose page’ from the drop down box and click on ‘Submit’.
You need to fill-in all the necessary details on the ‘Applicant Register’ page, by providing personal and organizational details. Complete the procedure by submitting it.
Required documents are asked to be submitted for the verification process from the CDSCO Officials in order to complete the process.
To verify the registration, a confirmation link will be sent to your registered email Id. Click on the link to activate your account on the CDSCO SUGAM portal.
After clicking on the confirmation link, the registration application will be sent to the concerned authority ‘officials of CDSCO’ for approval. If the application got approved by the officials, an email of approval will be sent to your registered email Id and vice versa for the case of rejection.
Importance of Ophthalmic Medical Device CDSCO Registration can be studied as follows:
The Professional Fee For CDSCO import Certificate for Cosmetic products is INR 99,999/- only with Professional Utilities.
The following are the documents required in the CDSCO registration for Ophthalmic Medical Devices:
CDSCO registration for Ophthalmic medical devices is a process of acquiring approval from the regulatory authority to access several benefits such as it improves a company's reputation, ensures public health, unlock market access, provides new market opportunities etc. It is a mandatory process to be done for working under government regulations.
At Professional Utilities, we leverage our industry knowledge and expertise to help businesses navigate complex regulations, minimize risks, and optimize operations for maximum efficiency and profitability.
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‘SUGAM’ is the registration portal of CDSCO.
CDSCO stands for Central Drugs Standard Control Organisation.
DCGI, Drug Controller General of India.
FDA Bhawan, Kotla Road,New Delhi.
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