The Directorate General of Health Services, Central Drugs Standard Control Organization (CDSCO) issued a notice on 12th February, 2024, regarding the online application process for obtaining a Neutral Code for manufacturing medical devices for export purposes.
The notice emphasizes the implementation of an online system for submitting applications through the Medical Devices portal, streamlining the regulatory submission procedure. It clarifies that the Neutral Code will be issued by the Central Licensing Authority under the Medical Devices Rules, 2017, and urges all stakeholders to adhere to the online submission process via the specified portal.
In essence, the notice introduces a new online application system for obtaining a Neutral Code for the manufacturing of medical devices intended for export. This system aims to simplify the regulatory submission procedure by providing an online platform through the Medical Devices portal. It specifies that the issuance of the Neutral Code will be carried out by the Central Licensing Authority under the Medical Devices Rules, 2017. The notice underscores the mandatory nature of the online submission process for all stakeholders and highlights the portal’s URL for reference. It is signed by Dr. Rajeev Singh Raghuvanshi, the Drugs Controller General (India), and is directed to various entities, including stakeholders through the CDSCO website, State/UT Licensing Authorities, and the CDAC Team.
