A medical device recall is a critical process designed to protect public health by removing or correcting defective products. Adhering to the Guidelines on Good Distribution Practices for Medical Devices (GDPMD) ensures that recalls are handled efficiently and transparently.
1. Purpose of the Medical Device Recall Process
The primary objective of this SOP is to outline the systematic approach for recalling quality-defective medical devices. This process is triggered whenever safety incidents are reported or when a product fails to meet established quality standards, ensuring that potentially harmful devices are removed from the supply chain immediately.
2. Roles and Responsibilities
An effective recall requires a coordinated effort across various departments. Below are the key stakeholders involved:
| Role | Responsibilities |
| Warehouse Officer | Responsible for execution, recording, and tracking products by lot/batch numbers and location. |
| Marketing Officer | Manages the safe return of the product from the market and communicates with customers. |
| Warehouse Incharge | Oversees the secure storage and final destruction of the recalled medical device. |
| Proprietor / CEO | Responsible for final decision-making, manufacturer communication, and implementation. |
3. Step-by-Step Operational Procedure for Recalls
To ensure a smooth medical device recall, the following operational steps must be followed:
Initial Action and Notification
- Triggering a Recall: If a complaint is filed or an adverse reaction is reported, the recall process must begin immediately to prevent further risk to patients.
- Stakeholder Communication: All internal personnel must be notified. The manufacturer or authorized representative should be consulted before proceeding with the recall whenever possible.
- Regulatory Reporting: The Medical Device Board must be formally informed regarding the recall status.
Execution and Inventory Management
- Management Decision: The CEO, in consultation with the Warehouse Officer, determines the product's fate and sets a strict timeline for the recall exercise.
- Customer Outreach: The Marketing team will contact all customers via telephone and email to inquire about current stock levels and request inventory copies.
- Recipient Tracking: Marketing and Warehouse teams will compile a comprehensive list of all recipients who received the defective batch.
Handling and Disposition
- Quarantine and Labeling: All returned devices must be segregated from saleable stock, labeled clearly as "Non-Conforming," and kept in a designated secure area.
- Manufacturer Coordination: The Warehouse takes control of the physical stock and communicates findings to the supplier/manufacturer through the CEO.
Destruction or Return: * Destruction: If destruction is required, a formal destruction certificate must be signed by the Warehouse and CEO.
- Ship-Back: If returning to the manufacturer, all export documentation must be completed.
- Financial Adjustment: The Finance department must be notified to adjust stock values and account for losses.
Documentation
All data related to the medical device recall must be maintained in both printed and electronic formats for audit readiness and regulatory compliance.
4. Regulatory Reference
This procedure is developed in accordance with the Guidelines on Good Distribution Practices for Medical Devices (GDPMD) to ensure the highest standards of safety and quality control.
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