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

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.

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.

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.

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.

CDSCO Fee for Product

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

Note: The aformentioned Fees is exclusive of GST.

Documents for CDSCO Test License for Medical Devices

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

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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