What is the validity of CDSCO import license for Medical Device?

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The validity of a CDSCO import license for medical devices in India is generally 5 years from the date of issuance. After this period, the license must be renewed if the importer wishes to continue importing and distributing the medical device in India.

Key points to note:

1. Import License Type: The license issued by the Central Drugs Standard Control Organization (CDSCO) is typically for the import of medical devices and may be required for devices categorized as Class A, B, C, or D based on their risk classification.

2. Renewal: The license is valid for 5 years, but it is important for the license holder to apply for renewal before it expires. Renewal applications should be submitted in advance to avoid disruptions in the ability to import and distribute medical devices.

3. Conditions: The license is issued subject to compliance with relevant regulatory norms, which include ensuring the devices meet the standards specified by the CDSCO, such as obtaining CE marking, ISO certification, and/or other relevant regulatory approvals depending on the classification of the device.

4. Regulatory Changes: The regulatory environment for medical devices in India is evolving, and importers must stay updated on any changes to requirements, including licensing procedures, standards, and fees.

It’s always a good practice to check with the CDSCO or an authorized consultant for the latest updates and detailed procedures regarding the import license for medical devices.
Ensure seamless entry of your medical devices into the Indian market—apply for your CDSCO import registration today and stay compliant with the latest regulatory standards!