Last Updated on April 20, 2025 by The Health Master
Neutral Codes
The Central Drugs Standard Control Organisation (CDSCO), has issued a public notice on 09-04-2025 regarding the automated generation of important certificates for medical device manufacturers.
This decision aims to simplify the regulatory procedures and boost the ease of doing business within the sector of medical devices.
Auto-Generated Neutral Codes
In the above-said public notice, the CDSCO has announced the implementation of auto-generated neutral codes under the Medical Devices Rules (MDR), 2017.
This new system can be accessed through the existing online medical devices portal.
Highlights of the Neutral Code Automation:
Boosting up the efficiency:
This automated certificate-generated system will reduce the time for obtaining neutral codes and other certificates.
Boosting up the Transparency:
Manufacturers of medical devices having valid licenses can directly download the neutral code from their dashboard of the system.
No manual issuance of certificates:
The previous manual process for obtaining neutral codes from the Central Licensing Authority has been discontinued from the date of the new procedure’s implementation.
Appeal to manufacturers:
Dr. Rajeev Singh Raghuvanshi, Drugs Controller General India (DCGI) has made an appeal to all manufacturers of medical devices and other stakeholders to adopt the new online process to obtain system-generated neutral codes for export purposes.
This automation builds upon the CDSCO’s earlier move in February 2024, which mandated online applications for neutral codes, further solidifying the digital transition for export-related processes.
Automated Market Standing Certificate (MSC) and Non-Conviction Certificate (NCC)
Simultaneously, the CDSCO announced the upgrade of the online application workflow for the grant of Market Standing Certificates (MSC) and Non-Conviction Certificates (NCC). This upgrade introduces an automated system for generating these vital documents.
Q. What is a Neutral Code for medical devices?
A. A neutral code is used by medical device manufacturers to export their products without revealing their company name or specific details on the packaging.
Q. Why is the CDSCO automating these processes?
A. To promote ease of doing business, simplify regulatory procedures, and enhance efficiency.
Q. Where can manufacturers access the new automated systems?
A. Through the existing online medical devices portal.
Q. What happens to previously submitted applications for MSC and NCC?
A. All applications submitted under the old workflow will be automatically rejected. Stakeholders need to re-submit fresh applications.
Q. When did the new procedures come into effect?
A. From the date of the public notice issued on April 9th.
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
Procedure to obtain license for manufacturing of Medical Devices
Procedure for registration of Medical Devices: CDSCO
Qualification and Experience: For Technical Staff in Medical Devices
Registration for sale of Medical Devices: Procedure and conditions
Latest Notifications: Medical Devices
Classifications of Medical Devices under the provisions of MDR 2017
Notified Bodies for Medical Devices
Updated list of Notified Bodies for Medical Devices
Updated list of Medical Device Testing Laboratories (MDTLs)
Forms: All types of Medical Devices
Schedules: All types of Medical Devices
CDSCO updates Medical Devices Classification
Medical Device recall: Medtronic embolization recalled, classified as ‘most serious’
Medical Device Manufacturing Hubs in India: State-Wise Detail
Streamlining licensing of Class A and B Medical Device
Qualification and Experience: For Technical Staff in Medical Devices
FDA Maharashtra seizes drugs worth Rs 61.95 lakh
Fake QR Codes on Top medicines uncovered in Gujarat
CDSCO SOPs: New Guidelines for SEZ-Manufactured Drugs in India
Key Notes on Revised Schedule M: API Part-3
18 New Drug Inspectors to Boost Enforcement soon: Tamil Nadu
Pregabalin Misuse: A National Concern
Drug Regulator Safety Under Threat: West Bengal
Drug Recall: Strides Pharma recalls Testosterone Gel
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
