CDSCO Introduces Online Application System to issue Neutral Code for manufacturing Medical Devices for export

Written By :  Dr. Divya Colin
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2024-02-21 12:30 GMT   |   Update On 2024-03-22 12:46 GMT

New Delhi: With an aim to streamline the regulatory submission procedure, and to enhance efficiency and facilitate smoother regulatory procedures, the Central Drugs Standard Control Organization (CDSCO) has introduced an online application system for obtaining a Neutral Code for the manufacturing of medical devices intended for export purposes.The Neutral Code, crucial for manufacturers...

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New Delhi: With an aim to streamline the regulatory submission procedure, and to enhance efficiency and facilitate smoother regulatory procedures, the Central Drugs Standard Control Organization (CDSCO) has introduced an online application system for obtaining a Neutral Code for the manufacturing of medical devices intended for export purposes.

The Neutral Code, crucial for manufacturers intending to export medical devices, will be issued by the Central Licensing Authority as per the guidelines outlined in the Medical Devices Rules, 2017.

The online application system is now operational through the Online System of the Medical Devices portal (https://cdscomdonline.gov.in). Applicants seeking a Neutral Code are required to submit their applications through this portal, adhering to the checklist provided therein.

It is important to note that the issuance of the Neutral Code to manufacturers will be carried out by the Central Licensing Authority under the Medical Devices Rules of 2017.

In light of the above, through the recent notification, the Central Drugs Standard Control Organization (CDSCO) has urged all stakeholders to exclusively utilize the Online System of Medical Devices portal (https://cdscomdonline.gov.in) for the submission of applications related to the Neutral Code.

To view the notice click the link below:

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