Ensuring the integrity of healthcare products requires a rigorous process for the receiving, storage, and handling of medical devices. Whether products are imported or procured locally, maintaining quality compliance is essential for patient safety and regulatory adherence.
This guide outlines the standardized operational procedures (SOP) used by industry leaders like to manage supply chain excellence.
1. Purpose of Medical Device SOPs
The primary objective of these procedures is to establish a foolproof system for managing both imported and locally procured medical devices. By following a structured protocol, organizations can minimize risks such as damage, contamination, or inventory errors.
2. Scope of Operations
These guidelines apply specifically to the Supply Chain Department. It covers the entire lifecycle of a medical device from the moment a purchase intent is signaled until the product is ready for distribution.
3. Roles and Responsibilities
Effective management requires clear accountability. Below are the key stakeholders involved in the medical device supply chain:
| Role | Responsibility |
| Import Manager | Responsible for the proper implementation and total compliance of the SOP. |
| Warehouse In-charge | Monitors compliance, manages revisions, and ensures physical storage standards. |
| Proprietor/Director | Provides final approval for the SOP and financial clearances. |
4. Operational Procedure: Step-by-Step
To ensure the safe handling and storage of medical devices, the following workflow is followed:
Phase 1: Procurement and Documentation
- Order Initiation: The sales team secures purchase orders from distributors or institutions and relays them to the Import Department.
- Inventory Audit: The Import Manager checks current stock levels and calculates product lead times.
- Financial Setup: A Purchase Order (PO) is generated, a Proforma Invoice is requested, and financial instruments (LC, Bank Contract, or TT) are established.
- Compliance: The Import Manager prepares the Electronic Import Form (EIF) and maintains constant communication with the manufacturer.
Phase 2: Logistics and Customs Clearance
- Shipment Coordination: Once the shipment is ready, the Import Manager coordinates with freight forwarders.
- Documentation for Clearing: Upon arrival at airports or seaports, the Commercial Invoice, Packing List, and Airway Bill are forwarded to clearing agents for GD filing.
- Duty Payments: The Account Officer processes pay orders for custom duties and taxes following director approval.
Phase 3: Receiving and Inventory Management
- Stock Reception: The warehouse team receives the goods, inspecting for damage or discrepancies.
- FIFO Protocol: Inventory is updated using the First-In, First-Out (FIFO) method. This ensures that medical devices with earlier expiration dates are distributed first, maintaining high quality-control standards.
- Final Distribution: Once logged, the stock is cleared for sale and distribution to healthcare providers.
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