Get Materiovigilance Programme Of India 2020-2025
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How to fill out the Materiovigilance Programme Of India online
Filling out the Materiovigilance Programme Of India form online is essential for accurately reporting adverse events related to medical devices. This guide will provide you with clear and structured steps to ensure you complete the form correctly, making the process seamless and efficient.
Follow the steps to fill out the Materiovigilance Programme Of India form online.
- Click ‘Get Form’ button to access the Materiovigilance Programme Of India form and open it in an editor.
- Begin by entering the patient details in section A. Fill in the Patient ID and Age at time of event or Date of Birth.
- Proceed to section B for incident details. Describe the incident and tick the appropriate reasons for the incident. Indicate the seriousness of the event by selecting the appropriate option.
- Record the date of the incident in the designated field (dd/mm/yyyy) and provide the location of the event, selecting one of the provided options such as OPD, IPD, or Others.
- Indicate the device category (e.g., Therapeutic, Diagnostics) and provide the date of the last preventive maintenance and calibration.
- Fill in the location of the device after the incident, specifying whether it was in use, and indicate if a similar device is available in the organization.
- Complete section C, providing detailed information about the medical device(s), including GMDN Code and Name, Manufacturer/Importer, Brand Name, Model No., Serial No., Batch No., and the date of installation or implant.
- In section D, fill in the regulatory details, including the Manufacturer's name and the country of regulatory approval.
- Complete section E with the reporter details. Include your name, address, email, phone number, designation, and sign the form.
- Finally, check section F for causality assessment details and provide any additional information as needed.
- After reviewing the completed form for accuracy, save your changes, and then you can download, print, or share the form as necessary.
Complete the Materiovigilance Programme Of India form online to ensure accurate reporting of medical device adverse events.
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The approval time for medical devices can vary, but it usually takes between 6 to 12 months. Factors such as device complexity and documentation quality impact this timeline. By understanding the Materiovigilance Programme Of India, you can align your documentation accordingly. Taking proactive steps can help facilitate a quicker approval process.
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