Mandatory Requirements for Medical Device Reporting (MDR)-- Medical Device Reporting (MDR) in the US mandates the reporting of adverse events and malfunctions related to medical devices to ensure their safety and effectiveness, and it is governed by the FDA\\'s 21 CFR Part 803. The FDA mandates manufacturers, importers, and device users to report medical device-related adverse events causing death, serious injury, or major health risks. Manufacturers, importers, and device user facilities are required to report device malfunctions posing a potential risk of death or serious injury. Timely Reporting: Reports must be submitted to the FDA promptly, usually within 30 days of awareness, and within 5 days for device malfunctions with potential for serious harm or death. User Facility Reporting: Healthcare facilities must report device-related deaths to manufacturers and the FDA, along with reporting serious injuries to manufacturers. Manufacturer Reporting: Manufacturers must submit MDRs for events they become aware of, including reports from healthcare professionals, user facilities, patients, and various sources. FDA Form 3500 Series: MDR reports are submitted using the FDA Form 3500 series; these forms capture crucial details about device, event, and patient data for FDA reporting. Unique Device Identifier (UDI): Manufacturers must include the Unique Device Identifier (UDI) in MDR reports for precise medical device identification. Follow-Up Reporting: Mandatory follow-up reports are necessary if new information arises subsequent to the initial filing by manufacturers. Steps for Online Application for Registration of Cosmetics Access the portal using the link http://cdscoonline.gov.in. Signup and create login credentials. Submit all the details with a valid e-mail ID and mobile number (for alerts) and complete the signup process. After successful signup, login into the portal. In the form sub-section, select department and type of form. Choose the type of application to be submitted (e.g., Fresh, Endorsement). After final submission, view the form details and click on "Continue" to proceed. You will be redirected to the "Preview" page. Once moved to "Checklist" page, no further modifications in the application form will be allowed. Click on each point to upload documents electronically. Upload all the documents and click on "Submit" on the checklist page to proceed. It will be redirected to the "Payment" page. Fill in the form details and click on "Submit" to proceed. It will be redirected to the "Preview" page. Multiple challans can be uploaded, up to a maximum of five challans. Click on "PDF" to generate the PDF of the filled form. Full preview will include details of the payment done by the user.