CDSCO Test License for Medical Device- Process, Documents, Benefits

Updated on May 06, 2024 06:40:24 PM

CDSCO, India's National Regulatory Body for Cosmetics, Pharmaceuticals and Medical Devices. CDSCO Test License is issued by DCGI under Central Drugs Standard Control Organisation.

CDSCO Test License for Medical Devices is a process of obtaining approval from the regulatory authority to ensure the efficiency and quality of the drugs, medical devices and pharmaceuticals and cosmetics.

Registration for CDSCO Medical Device

What is a CDSCO Test License for Medical Devices?

Under the Drugs and Cosmetics Act, CDSCO is responsible for approval of new drugs, conduct of clinical trials, laying down the standards for drugs in the country and coordination of activities of state drug control organization by providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.

The CDSCO grants licenses for the Medical Devices testing, import or manufacturing after carefully evaluating each application. It is granted for the purpose of import, sell and distribution of Medical Devices working under government regulations to be followed to remove any hindrances.

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What is CDSCO registration for a Test License?

CDSCO registration is a process of obtaining approval from the regulatory authority to ensure the efficiency and quality of the medical devices, cosmetics, drugs, pharmaceuticals and cosmetics.

The selection of applications varies according to the device type, risk state of the drug, applicant characteristics, operations and home country approval by following all the government regulations.

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Procedure for CDSCO Test License for Medical Devices

Procedure to obtain CDSCO Test License for Medical Devices is as follows;

Step 1:Signing up for the application

Visit the official website of CDSCO, Sign Up in the ‘SUGAM’ Portal for the registration application.

Step 2:Fill up the Details

Fill all the necessary details in the form. The form is divided into two parts, the applicant needs to fill all his/her personal and organizational details

Step 3:Documentation

Required documents are mandatory to submit for the verification process for authorizing the CDSCO Test License.

Step 4:Verification of the registration

Click on the verification link sent to the registered email Id to activate your account in the ‘SUGAM’ portal for the CDSCO Test License.

Step 5: Approval from the Authority

After the confirmation, the registration application will be sent to the concerned authority for the approval of the license

If the application got approved by the CDSCO officials, an email of approval will be sent to the registered email Id, vice versa for the case of rejection.

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Benefits of CDSCO Test License

CDSCO Test License provides several benefits as:

  • No Custom Stoppage: Having a CDSCO license shows the transparency of following all the government policies for the import activity of Drugs. In India, import, manufacture, sale, and distribution of drugs is regulated by DCGI under the Central Drugs Standard Control Organisation.
  • Safety & Quality of Products: CDSCO registration ensures that cosmetic products don't include any harmful preparations and are suitable for all, assuring that the products are safe to be consumed by the masses.
  • Legal Compliance: Legal compliance is the process or procedure to ensure that an organization follows relevant laws, regulations, and business rules. CDSCO registration is a mandatory process to get access for the approval from the regulatory authority to ensure the efficiency and quality of Cosmetic Products.
Benefits for Bone Marrow Cell
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CDSCO Fee for Product

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

Note: The aformentioned Fees is exclusive of GST.

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Documents for CDSCO Test License for Medical Devices

Documents for Bone Marrow Cell

Documents required in CDSCO Test License for Medical Devices are as follows:

  • Identity proof of the applicant
  • Address proof of the applicant
  • Undertaking allotted by a Government Authority
  • Copy of BE or BA Site Registrations as issued by CDSCO in case of BE or BA approved sites Registration
  • Manufacturing License or Wholesale Licenses in case of Import or Manufacture of Drugs/Blood Product Registration/Test license Registration
  • Form-12
  • TR-6 Challan utilization or justification
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Conclusion

CDSCO stands for Central Drugs Standard Control Organisation which grants license for the device testing, import or manufacturing after carefully evaluating each application. The application for registration Certificate and Import License is made under the Act to the licensing authority.

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Frequently Asked Questions

What is the Central Drugs Standard Control Organisation?

CDSCO is India's National Regulatory Body for Cosmetics, Pharmaceuticals and Medical Devices.

What is the full form of DCGI?

DCGI,Drug Controller General of India regulates Pharmaceuticals and Medical Devices under CDSCO.

What is the online process of CDSCO registration?

Signing up for the application,fill up the details,documentation,verification of the registration,approval from the authority,

In India import,manufacture,sale and distribution of drugs is regulated under which act?

Under Drugs & Cosmetics ACt 1940, and rules 1945.

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