Navigating the process for medical device returns requires strict adherence to safety and regulatory standards. Whether due to defects, shipping errors, or expired stock, a structured return policy ensures patient safety and inventory accuracy.
This guide outlines the formal procedure for the return and disposal of medical devices in compliance with Good Distribution Practices for Medical Devices (GDPMD)
1. Purpose and Scope
The purpose of this procedure is to establish a clear, documented system for the return and disposal of medical devices. This SOP applies to all categories of medical devices returned from the market to our distribution or warehouse facilities.
2. Roles and Responsibilities
Managing medical device returns involves cross-departmental coordination to ensure financial and physical inventory stay synchronized.
- Sales & Marketing Team: Responsible for authenticating valid returns by verifying original Invoices or Delivery Challans.
- Warehouse Incharge: Inspects returned goods to determine re-saleable status and manages the physical storage or destruction.
- Accounts Manager: Maintains the data records and generates monthly reports on returned goods for financial auditing.
3. Operational Procedure for Product Returns
Authentication and Verification
Before any medical device return is accepted, marketing personnel must verify the validity of the request. This is done by matching the product against the original Invoice or Delivery Challan to ensure the goods originated from our authorized supply chain.
Quality Inspection and Categorization
Once a return is authenticated, the Warehouse Incharge performs a critical inspection to categorize the devices:
- Re-saleable Products: Goods that are undamaged, unopened, and meet safety standards. These are returned to active inventory.
- Defective/Non-Saleable Products: Goods that are damaged, expired, or compromised. These are moved to a designated "Quarantine" area for destruction.
Inventory and Disposal
- Stock Management: The warehouse maintains a dedicated inventory log of all returned stocks.
- Destruction Process: Defective products are disposed of following safety protocols. A Destruction Certificate is issued and forwarded to the Accounts department.
- Financial Reporting: The Accounts department reconciles the inventory and generates a comprehensive monthly report.
MEDICAL DEVIES RETURN FORM
When good are
to be returned to a supplier form any reasons, this form is to be completed.
Please forward
this complete form to store along with the good to be returned
Ship To:
__________________________ Date: _____________________
Address:
__________________________ P.O No: ___________________
Fill in below,
the purchase order description of the goods, the prices and quantity returned.
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Total Price |
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Reason for
return: _________________________________________________________
_________________________________________________________
_________________________________________________________
_________________________________________________________
_________________________________________________________
_________________________________________________________
Department________________ Signature_____________________