CDSCO registration for Ophthalmic Medical Devices - Procedure, Documents, Fees

 

 

 

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.

 

 

 

 

 

What are Ophthalmic Medical Devices?

 

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.

 

 

 

What is CDSCO registration for Ophthalmic Medical Devices?

 

 

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.

 

 

Procedure for CDSCO registration for Ophthalmic Medical Devices

 

 

Step 1:Signing Up

You need to Login/Sign Up on the registration portal which is ‘SUGAM’ on the official website of CDSCO.

Step 2:Registration Page

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’.

Step 3:Filling the details

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.

Step 4:Documentation

Required documents are asked to be submitted for the verification process from the CDSCO Officials in order to complete the process.

Step 5:Verification 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.

Step 6:Approval from the authority

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

 

 

Importance of Ophthalmic Medical Device CDSCO Registration can be studied as follows:

• Improves a Company’s Reputation: CDSCO registration for Ophthalmic devices improves a company’s reputation as it provides a security of working under legal compliance, referring to a process or procedure to ensure that an Organization follows relevant laws, regulations and business rules.
• Ensuring Public Health: CDSCO is constantly striving to bring out transparency, accountability and uniformity in its services in order to ensure safety, efficacy and quality of medical devices manufactured, imported and distributed in the country. The main job and objective of CDSCO is to safeguard Public Health.
• Unlock Market Access: CDSCO Registration is required before dealing with Drugs, Medical Device and Cosmetic Products, it makes sure that they are free of heavy metals and other toxins for being safe to be consumed by the masses, CDSCO provides new opportunities in the Market.

 

 

 

CDSCO Fee for Product

 

The Monitrix Fee For CDSCO import Certificate for Cosmetic products is INR 99,999/- only with Monitrix.

 

 

Documents For CDSCO registration for Ophthalmic Medical Devices.

 

 

The following are the documents required in the CDSCO registration for Ophthalmic Medical Devices:

• Application Form MD 3 for application and MD 5 for license
• Covering Letter
• Plant Master Report
• Device Master Report
• Constitution of Firm
• Tenancy Agreement
• Copy of Duly notarized valid copies quality Certificate
• ISO Certificate-13485
• Device Master File
• Performance evaluation report
• Undertaking from government authority

 

 

 

Conclusion

 

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.