CDSCO directs manufacturers & importers of Class C&D non-notified medical devices to submit application for license

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The Central Drugs Standard Control Organisation (CDSCO) has instructed the manufacturers and importers of these devices to apply for grant of manufacturing or import licence with all necessary documents and fees in accordance with the regulation in an effort to bring about a smooth transition of the Class C and D non-notified medical devices from the current mandatory registration to licencing regime. The transition to a licencing regime for medical devices that are moderately high risk (Class C) and high risk (Class D) is expected to be finished in 42 months from the date of notification on April 1, 2020. According to this, the licencing system for certain medical devices is anticipated to begin on October 1, 2023.

By mandating that businesses register their items under these Classes with the regulator, the CDSCO earlier started the processes necessary for a smooth transition. This is intended to assist these manufacturers, importers, and the regulator by allowing timely submission and verification of data and quality certifications. In a recent circular, the drug regulator noted that, in order to ensure compliance with the Fifth Schedule of the Medical Devices Rules (MDR) 2017, the inspection required by the Medical Devices Officers (MDO) of the Central Licencing Authority (CLA) must be completed within 60 days of the date of application for the grant of a manufacturing licence for Class C and D medical devices.

In-depth information on the quality management system for medical devices and in vitro diagnostic devices is provided in the Fifth Schedule of the MDR, 2017, which also covers general requirements, documentation requirements, management responsibility, resource management, product realisation, design and development, validation of processes for production and service, traceability, and monitoring, among other things. Dr. Rajeev Singh Raghuvanshi, Drugs Controller General (India), suggested that manufacturers and importers apply for grant of manufacturing or import licence with all necessary documents and fees as per MDR, 2017, through portal in order to have smooth transition from mandatory registration to licencing regime.

The supply chain for these medical devices and patient access, he continued, will not be disrupted by processing the application in a proactive manner so that licensure can be provided within the allotted time frame. The MDR, 2017, mandates that producers of Class C or D devices submit their applications online using the requisite forms. Where necessary, the CDSCO may also enlist the assistance of any expert in the field to review the applications and other technical papers. If the documents are found to be correct and complete, the CLA shall order an inspection of the manufacturing site under Rule 23 by a team of officers assisted by such experts as may be deemed necessary. The scrutiny must be completed within 45 days of the date the application was submitted online.

According to the regulations, the CLA may use the services of a notified organisation to inspect the factory where Class C and D medical devices are made. The CLA must reject the application and email the applicant with the grounds for such rejection if the provided documents are not deemed to be accurate and complete. The inspection must be completed within 60 days, and a copy of the inspection report must be forwarded to the applicant together with the inspection report submission to the CLA.

According to the MDR, 2017, the CLA must grant a licence or loan licence within 45 days of receiving the inspection report if it determines that the requirements of the rules have been satisfied. If not, the CLA may reject the application for reasons that must be documented in writing.

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