On February 12, 2024, the Central Drugs Standard Control Organization unveiled a notable improvement in the regulatory submission process for acquiring a Neutral Code to manufacture medical devices for export. To enhance efficiency, stakeholders can now utilize the Online System of Medical Devices portal, accessible atย https://cdscomdonline.gov.in, to initiate their Neutral Code applications. Previously, this procedure necessitated the submission of hard copy applications. This shift to an online platform is geared towards reducing paperwork and accelerating the issuance of licenses.
Understanding the Neutral Code for Exporting Medical Devices
The Neutral Code, also known as a special code, holds significant importance for manufacturers aiming to export medical devices. The Neutral code is issued by Central Licensing Authority (CLA) for medical devices of all risk classes. Essentially, the Neutral Code serves as a unique identifier to manufacturers, enabling them to replace their name and address on product labels. This allows streamlined contract manufacturing for export purposes and ensures traceability of every exported consignment while maintaining confidentiality regarding the manufacturer’s details. Through this mechanism, manufacturers approved by regulatory authorities can obtain a Neutral Code number, facilitating the export of medical devices without disclosing sensitive manufacturer information on product labels.
Obtaining a Neutral Code for Medical Devices
When a manufacturer-exporter submits a comprehensive application along with all relevant documents, the licensing authority evaluates it to grant a Neutral Code number for exporting the respective medical device. The following documents are necessary for the application seeking permission to utilize the Neutral Code for exporting medical devices.
- Covering letter indicating the purpose of Neutral Code Certificate
- User charges (Receipt in Original) fee of Rs.500/-
- Copies of Manufacturing License.
- Copy of the list of products meant for export.
Before exporting the consignment, port authorities meticulously scrutinize the shipment to ensure compliance with the Neutral Code requirement. The Neutral Code, presented in a clear format, serves as a crucial identifier. The consignment to be exported would be verified by port authorities to ensure the display of neutral code. The neutral code should be clear.
All stakeholders are advised to adhere to this updated online application procedure. Manufacturers and industry representatives seeking the Neutral Code are urged to make use of the portal and verify adherence to the provided checklist. The comprehensive notice issued by CDSCO is accessible here: https://shorturl.at/eCEN2
Ready to ensure compliance with Neutral Code requirements or navigate other regulatory services for medical devices in India? Contact 8C Healthcare today! Our expert team is here to assist you every step of the way. Visit our website or reach out via email at contact@8chealthcare.com to get started. Let us help you streamline your regulatory processes and achieve success in the Indian market.
