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MEDICAL DEVICE ADVERSE EVENT REPORTING FORM Materiovigilance Programme of India FOR MDMC/NCC USE ONLY Type of report: Initial Followup Report No. : A. PATIENT DETAILS 1. Patient Hospital ID 3. Age.

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Mandated Timeliness For Medical Device Reporting Importers must submit a report within 30 days of becoming aware of a reportable event. Once a medical device manufacturer becomes aware of a reportable death, serious injury or malfunction, it has 30 days to report the adverse event to the FDA.

Your health care provider is NOT required to report to the FDA....Submitting Adverse Event Reports to FDA Report Online. Consumer Reporting Form FDA 3500B. ... Call FDA at 1-800-FDA-1088 to report by telephone.

INDIAN PHARMACOPOEIA COMMISSION (National Coordination Centre-Pharmacovigilance Programme of India) PvPI Helpline (Toll Free) :1800-180-3024 (9:00 AM to 5:30 PM, Monday-Friday) Version 1.4.

Submit reports to the FDA through the MedWatch program in one of the following ways: Complete the MedWatch Online Reporting Form. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

1800 180 3024 to report Adverse event.

Yes, as of October 1, 2021, all medical devices require registration or an Import License with the CDSCO before importing into India. Some products, called Notified medical devices, required a more extensive registration requiring a Device Master File, called an Import License.

India's CDSCO medical device regulations The rules came into force in January 2018 and devices are regulated by the Central Drugs Standard Control Organization (CDSCO), an agency of the Ministry of Health and Family Welfare.

Submit reports to the FDA through the MedWatch program in one of the following ways: Complete the MedWatch Online Reporting Form. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

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© Copyright 1997-2025
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Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232