 The Central Drugs Standard Control Organisation (CDSCO) has released a draft guidance document to help the in-vitro diagnostics (IVD) medical devices importers for submission of import license applications through online portal.
The drug regulator said that the document is aimed at serving as guidance for importers for submitting product licence applications to CDSCO through the Medical Devices online portal of CDSCO and the National Single Window System (NSWS) portal.
It outlines the specific details to be furnished in each section of the application, ensuring alignment with the corresponding sections of the checklist for completeness and accuracy for getting timely approval.
The draft guidance document has been placed in the public domain for comments and suggestions from relevant stakeholders, and the CDSCO has requested all stakeholders to provide their comments or suggestions within 15 days, said the drug regulator while publishing the document in its website on February 2.
The document outlines the applicable regulatory framework and pathways, procedural steps, documentation requirements, and compliance obligations that must be fulfilled in accordance with the Medical Devices Rules, 2017 (MDR-2017).
The guidance document elaborates on the pathways to be followed by the industry to submit application under Form MD 14 for issue of import license to import medical devices, and MD 16 for license to import medical devices for the purposes of clinical investigations or test or evaluation or demonstration or training.
For MD-14, the application for grant of registration or license for IVD medical devices shall be submitted in the online system of www.cdscomdonline.gov.in, while the MD016 should be submitted on the NSWS portal.
The document clarifies that for the applications in MD-16, the system will auto allocate the applications submitted in NSWS portal to nodal officer (NO), and the application will then be allocated to review officer (RO). The review officer will review the application, which will then be evaluated by the nodal officer.
It will then go for evaluation by the deputy decision authority (DDA). If the application is incomplete at this stage, queries will be raised to the applicant, and following their response, it will go back to the RO for review. Once the DDA finds the application complete, it would then move to the licensing authority (LA), and to approval of import test license in form MD-17.
Similarly, the application submitted in the CDSCO's medical devices online portal under MD-14 will be auto allocated to RO, and then be forwarded to the NO for evaluation. The application would then be evaluated by the DDA. If the application is incomplete, the DDA would raise queries to the applicant, and following the applicant's response, the application would go back to the RO for consideration once again.
Once the application gets completed, the DDA would pass it to the LA for grant of import license in Form MD-15.
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