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In India, the regulatory agency in charge of licensing and overseeing medications, cosmetics, and medical devices is the Central Drugs Standard Control Organisation (CDSCO). In order to expedite the approval process and guarantee the safety, effectiveness, and quality of these items, CDSCO has put in place an online registration system.<br>https://indibloghub.com/post/fast-track-your-product-launch-with-cdsco-online-registration
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Approval process for Application received Online Sugam Portal for grant of Import licence / Permissions with respect to In Vitro Diagnostics. Step-1: Registration of applicant with MD portal Select Application type / Form No- 14/16/20/24/28 Applicant User Registration (One Time) User Profile- Manufacturer Address Repository & Category (IVD) In Vitro Diagnostic Details Undertaking for providing correct information Applicant & Manufacturer Details Components/Accesso ries details Submission of application by the applicant Upload Checklist Documents Upload Payment Challan
Step-2: Submission and processing of application Applicant registered with MD portal Online submission of application with requisite documents and Fees Application received by Nodal Officer (NO) Application forwarded to Reviewing Officer (RO) After review forwarded to NO If any deficiency in documents Query After review forwarded to DDA/DA If all the documents are in Order Forwarded to LA Approval