**Summary:**
This notice from the Central Drugs Standard Control Organization (CDSCO), Medical Devices Division, announces the implementation of an online application system for Neutral Codes required for manufacturing medical devices intended for export. Effective immediately, all applications for Neutral Codes must be submitted through the Online System of Medical Devices portal: https://cdscomdonline.gov.in. This initiative aims to streamline the regulatory submission procedure. The Central Licensing Authority, as defined under the Medical Devices Rules, 2017, will issue the Neutral Codes. All stakeholders are directed to use the online portal for Neutral Code applications. Inquiries can be directed through the CDSCO website. State/UT Licensing Authorities are requested to take note and implement accordingly. The Drugs Controller General of India, Dr. Rajeev Singh Raghuvanshi, issued the notice on February 9, 2024.
Key Entities Referenced
Central Drugs Standard Control Organization: A national regulatory body in India responsible for the regulation of pharmaceuticals and medical devices.
Medical Devices Rules, 2017: The regulatory framework in India governing the manufacturing, import, sale, and distribution of medical devices.
Medical Devices: Equipment, apparatus, or tools used for medical purposes.
Neutral Code: A code issued for manufacturing of Medical Devices for export purpose.
Online System of Medical Devices portal: An online platform (https:cdscomdonline.gov.in) for regulatory submissions related to medical devices.
Central Licensing Authority: The authority responsible for issuing licenses under the Medical Devices Rules, 2017.
Dr. Rajeev Singh Raghuvanshi: Drugs Controller General India
New Delhi: Location of Food Drugs Administration Bhawan
File No. MED-13011(15)/3/2024-eottice (Computer No. 3641)
F. No. MED-13011(15)/3/2024-eoffice
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
NOTICE
Subject: Online application for Neutral Code for manufacturing of Medical Devices
for export purpose - reg.
In order to streamline the regulatory submission procedure, for issuance of
Neutral Code to the applicant for manufacturing of Medical Devices for export
purpose is now functional through Online System of Medical Devices portal
(https://cdscomdonline.gov.in). The applicants seeking for Neutral Code shall now
apply through online portal as per the checklist provided on the portal.
It is pertinent to mention that the Neutral Code to the manufacturer will be issued
by the Central Licensing Authority under Medical Devices Rules,2017.
In view of the above, it is requested that all stakeholders shall submit application
related to Neutral Code through Online System of Medical Devices portal only
(https://cdscomdonline.gov.in).
(Dr. Rajeev Singh Raghuvanshi)
Drugs Controller General (India)
To,
1. All stakeholders through CDSCO Website
2. State/UT Licensing Authorities (for information and necessary action)
3. CDAC Team
2
Generated from eOffice by RAJEEV SINGH RAGHUVANSHI, DCI-RSR-CDSCO, DCG(!), CDSCO-HQ on 09/02/2024 12:31 PM