CDSCO Medical Device Registration for IVD Lab Kits - Meaning, Procedure, Importance

Updated on November 27, 2023 03:22:03 PM

The Central Drugs Standard Control Organisation is the National Regulatory Authority of India, being the highly powerful organization in India. It comes under the Directorate General of Health services, Ministry of Health and Family Welfare and Government of India.

Within the CDSCO, the Drug Controller General of India (DCGI) regulates Pharmaceutical and Medical Devices and its positioning. CDSCO is responsible for the approval of new drugs and granting of licenses under the Drugs and Cosmetics Rules, 1945.

Registration for IVD Lab Kits

What are IVD Lab Kits?

IVD is an In Vitro Diagnostics Medical Device that is used to test human samples. In-Vitro Diagnostics (IVDs) are tests that can identify diseases, disorders, and infections.

In vitro diagnostic (IVD) devices are tests performed on samples taken from the human body, such as swabs of mucus from inside the nose or back of the throat, or blood taken from a vein or fingerstick. IVDs can detect diseases or other conditions and can be used to monitor a person's overall health to help cure, treat, or prevent diseases.

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What is CDSCO Registration for IVD Lab Kits?

Manufacturing, importing and selling of IVD Lab Kits are labeled as Drugs in India. CDSCO Registration for IVD Lab Kits is a process of obtaining a manufacturing license for IVD Medical Devices by the manufactures to perform certain activities as Manufacture, Import, Clinical Performance, Sale and Distribution of IVD Medical Devices or Lab Kits in India.

IVD Medical Devices shall be classified into different classes based on their risk levels as:-

  • Class A - Low Risk
  • Class B - Moderate Low Risk
  • Class C - Moderate High Risk
  • Class D - High Risk
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Process For CDSCO Medical Device Registration for IVD Lab Kits

Process to do CDSCO Registration for IVD Lab Kits can be seen as follows:

Step 1:CDSCO registration Portal

You need to visit the official website of CDSCO, then you have to apply on the registration portal which is “SUGAM”. Click on the ‘SIGN UP HERE’ option to apply for the registration.

Step 2:Filling up the details

Fill up the space with your required details. Fill the ‘Applicant Registration Form’ providing the necessary personal and organizational details.

Step 3:Submitting the documents

Complete the application process by submitting the required documents for the verification process

Step 4: Call for Confirmation

A Confirmation link will be sent to the registered email Id to verify the registration. To activate your account on the SUGAM portal, you need to click on the confirmation link.

Step 5:Approval from the Authority

Once the Confirmation link is clicked, the application for registration will be sent to the concerned authority, to the CDSCO officials for approval of the license.

Step 6:Issuance of the license

After completing the whole procedure, your documents will undergo a verification process to see any secrecy. If the officer gets satisfied with the whole document procedure then your application will be approved.

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Importance of CDSCO Medical Device Registration

CDSCO Medical Device Registration for IVD Lab Kits has several

  • Regulatory Compliance: CDSCO Registration provides Regulatory Compliance, referring to a procedure of following relevant laws and regulations. CDSCO's objective is to safeguard the public health.
  • Safety & Quality of Products: CDSCO registration ensures that Medical Devices don't include any harmful preparations and are suitable for all, assuring that the products are safe to be consumed by the masses.
  • Unlock Market Access: CDSCO Registration is required before dealing with Drugs and Medical Devices. It makes sure that they are free of heavy metals and other toxins for being safe to be consumed by the masses. It provides new opportunities in the Market.
Benefits for IVD Lab Kits
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CDSCO Fee for Product

The Professional Fee For CDSCO Certficate is INR 99,999/- only with Professional Utilities.

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Documents For CDSCO Registration for IVD Lab Kits

Documents for IVD Lab Kits

Documents required in CDSCO Registration for IVD Lab Kits are as follows:

  • Power of Attorney
  • Details according to Annexure B (HIV, HBV, HCV, and Blood Grouping Sara)
  • TR6 Challan
  • Wholesale Drug License
  • ISO Certificate-13485
  • CE Design Certificate
  • Complete Quality Assurance Certificate
  • Declaration of Company
  • Plant Master File
  • Device Master File
  • FSC (Free Sale Certificate)
  • PMS Report (Post-Market Surveillance Report)
  • Performance Evaluation Report of Products
  • Original labels and pack sizes
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Conclusion

CDSCO is continuously striving to bring out transparency, accountability and uniformity in its service in order to ensure safety, efficiency and quality of the Medical Products and Kits which are manufactured, imported and distributed in the country. It is mandatory for the manufacturers to obtain a manufacture license for IVD Lab Kits in order to Manufacture, Import, Clinical Performance, Sale and Distribution of IVD Medical Devices or Lab Kits in India.

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Frequently Asked Questions

What are IVDs?

IVDs are In Vitro Diagnostics Medical Devices that are used to test human samples.

What is CDSCO Registration?

CDSCO Registration is a process of obtaining an approval from the regulatory authority to ensure the efficiency and quality of Pharmaceuticals,Medical Devices and Cosmetics.

What is the process to do CDSCO Registration for IVD Medical Devices?

CDSCO registration Portal, Filling up the details, Submitting the documents, Call for Confirmation, Approval from the Authority, Issuance of the license.

How to start the CDSCO Medical Device Registration for IVD Devices?

You can contact Professional Utilities for the complete procedure.

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