The Central Drugs Standard Control Organization (CDSCO) has listed new regulations to obtain clarification on the regulatory status of the Medical Devices. To get this clarification, the importer or manufacturer must submit a no-objection certificate (NOC). The applicant should submit a hard copy of the NOC to the Medical Device division in CDSCO.
Any Importer and local manufacturer can apply for Clarification NOC from CDSCO
Hard Copy of application needs to be submitted at CDSCO. Below information needs to be covered during application submission.
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Product details/Description |
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Regulatory Certificate from country of origin |
No fees will be required to obtain clarity regarding the regulatory status of the product
The validity of this is not specified.
To submit a NOC to the Medical Device division in CDSCO, the importer or manufacturer must also submit the following documents:
The details or description of the Medical Device. A regulatory certificate from the country of origin of the Medical Device.
The Government timeline is not specified
The importer or manufacturer must ensure that they have essential documents containing details of the Medical Device and the regulatory certificate from the country of origin of the Medical Device. As the timeline is not specified by the CDSCO, the application can take more than 30 days to process.
Product details/ Description
Regulatory Certificate from country of origin
The importer or manufacturer should ensure that they have listed the exact intended use of the Medical Device as claimed in the instructions for use.
A clarification NOC is a no-objection certificate issued by the CDSCO, which reflects the regulatory status of the Medical Device in India.
Both importers and manufacturers can apply for clarification NOC
