A comprehensive guide on the SOP for the import and local procurement of medical devices, covering supply chain roles, documentation, and operational steps.

Standard Operating Procedure: How to Import or Purchase Medical Devices

Efficient supply chain management is critical when you import or purchase medical devices. To ensure compliance and operational excellence, a structured Standard Operating Procedure (SOP) is essential. Below is the formal framework used by Aika Ceuticals to manage the procurement of life-saving medical technology.

1. Purpose and Scope

The primary purpose of this procedure is to streamline the workflow for both imported and locally procured medical devices.

This SOP is strictly applicable to the Supply Chain Department. It governs every stage of the process, from the initial intent to purchase medical devices to their final storage and distribution within the Aika Ceuticals network.

2. Roles and Responsibilities

Clear accountability ensures that the process of medical device procurement remains transparent and compliant with regulatory standards.

Role	Responsibility
Import Manager	Proper implementation and total compliance with the SOP.
Warehouse In-charge	Monitoring compliance and managing SOP revisions.
Proprietor	Final approval of the procurement and import protocols.

3. Operational Procedure: Step-by-Step

To successfully import or purchase medical devices, the following nine-step operational flow must be followed:

Step 1: Demand Generation

The sales team gathers purchase orders from authorized distributors or medical institutions. These orders are then forwarded to the Import Department to initiate the procurement cycle.

Step 2: Inventory & Lead Time Audit

Before a new order is placed, the Import Manager audits current store inventory and calculates product lead times to prevent overstocking or shortages.

Step 3: Documentation & Proforma Invoice

The Import Manager generates a formal Purchase Order (PO) and requests a Proforma Invoice from the manufacturer.

Step 4: Financial Approval

Once the invoice is received, the Import Manager secures approval to establish payment terms, such as a Letter of Credit (LC), Bank Contract, or Telegraphic Transfer (TT).

Step 5: EIF Preparation

The Import Manager prepares the Electronic Import Form (EIF) and maintains constant communication with the manufacturer regarding production timelines.

Step 6: Shipping & Customs Clearance

Upon shipment readiness, a Freight Forwarder is arranged. Once the shipment arrives at the airport or seaport, the Import Manager provides the Clearing Agent with the Commercial Invoice, Packing List, and Airway Bill for the Filing of GD (Goods Declaration).

Step 7: Duties and Taxes

The Account Officer, with approval from the Director, issues a Pay Order for all relevant custom duties and taxes to ensure the legal release of the goods.

Step 8: Warehouse Receiving (FIFO)

The Stores department receives the medical devices and updates the inventory system. All stock is managed using the FIFO (First-In, First-Out) method to ensure product efficacy.