76 Provision for system auto-generated Neutral code by the manufacturer for the export purpose under Medical Devices Rules, 2017 2025-Apr-09 338 KB

MED/52/2024-eoffice-Part (1) Government of India Directorate General of Health Services Central Drugs Standard Control Organization (Medical Devices Division)

Food & Drugs Administration Bhawan, Kotla road, New Delhi-110002 Dated: 0.9 APR 202

Subject: Provision for system auto-generated Neutral Code by the manufacturer for the export purpose under Medical Devices Rules, 2017-reg.

In order to promote ease of doing business and to simplify the regulatory procedure, the provision for system auto-generated Neutral Code is being made functional under the Medical Devices Rules, 2017 through existing Online System of Medical Devices portal (https://cdscomdonline.gov.in). The existing provision for issuance of Neutral Code by the Central Licensing Authority will be non-functional from the date of implementation of the new procedure.

Under the new provision, the manufacturer having valid manufacturing license shall obtain Neutral code through the option available in the approved manufacturing license from their dashboard for downloading the Neutral Code. In view of the above, it is requested that all the concerned stakeholders shall obtain system auto-generate Neutral code under Medical Devices Rules, 2017 through the new provision Online System of Medical Devices portal (https://cdscomdonline.gov.in) for the export purpose.

This is for the information of all stakeholders.

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To,

)

1. All stakeholders through CDSCO Website

2. State/UTs Licensing Authorities (for information)

3. CDAC Team