Procedure for Importation of products and Medical Devices

PRO/01
Approved by: Signature:
General Manager
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Original date: Version: Next Review Due on:
25th
October 2021 1st 25th October 2022

PURPOSE

 The purpose of this procedure is to describe the internal process of importation

and record keeping as per NHRA policy.

SCOPE
 This scope is applicable to all the purchase orders that are placed by the company
“Ammar Optician Company W.L.L” from its Manufacturers and principles.

RESPONSIBILITY DIVISION WITHIN THE COMPANY

 The office department will receive and initiate the order and start processing.
 The office department and the storekeeper is responsible for maintaining the
complete database of the supply and distribution of the medical devices/products
through the company software DOTLINE TECHNOLOGY.
 The office department is responsible for processing all the purchase orders.
 Storekeeper is responsible for maintaining the inventory using DOTLINE
TECHNOLOGY and intimating the office department when the inventory needs
to be updated.
 Each branch manager will be responsible for maintaining the inventory of the in
stock and distributed items in the software DOTLINE TECHNOLOGY.
 Storekeeper is responsible for receiving the shipment, its storage and it’s
verification of the shipment stock against the principle/manufacturer details.
 The drivers will be responsible for ensuring the shipment is packed and
transported with care and efficiency.
 Maintenance team and storekeeper are responsible for assessing the physical
condition of the stock and verifying it.
 The branch managers are responsible for ensuring that the branch staff comply
with NHRA regulations and company policies by entering the accurate and
complete details against each import voucher or purchase order.
 All records of importation and their traceability will be done through DOTLINE
TECHNOLOGY.

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PROCEDURE
 The inventory management is done using the DOTLINE TECHNOLOGY
software.
 Sales requests will be accepted only for those medical devices for which the
company has obtained a NHRA Import permit with the OFOQ portal.
 The office department will be maintaining a software-based database of all the
products received from the principle/ manufacturer and distributed to the end
users
 The storekeeper will be maintaining the database of all the products in stock and
managing the inventory.
 DOTLINE TECHNOLOGY software based data base will be used as a tracing
tool and will include, but not be limited to the following details:
1. Medical Device/Product name
2. Model
3. Serial Number
4. Batch Number
5. Lot Number
6. Manufacturer details
7. Country of Origin
8. Quantity
9. Price/Cost
10. End user details
11. Recall/adverse event/alert and modification record
12. Service reports/PPM

 The storekeeper will regularly check the stock to be sure that the present stock is
not insufficient
 If the stock is insufficient, the storekeeper will inform the office department and
they will draft and finalize a new purchase order request and forward it to the
general manager for approval.
 After obtaining approval, the Purchase Order request will be forwarded to the
manufacturer/principle for ordering.
 Manufacturer/principle will be requested to share the shipment details including:
1. Expected shipment delivery date

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 2. Shipping documents
 The shipment documents must be retained in a hardcopy master file at all times
from the placement of purchase order with the manufacturer and until shipment is
received.
 Once shipment delivery date is communicated by the principle/manufacturer, the
office department shall prepare the custom clearance documents which should
include:
1. Invoice copy
2. No. of containers/Bill of Purchase
3. Expected delivery Date
4. Custom Clearance documents
5. NHRA permit Copy
6. Delivery Note
 Once the shipment is received, the storekeeper along with the maintenance team
shall verify the received shipment quantity, quality and physically assess it.
 The storekeeper shall record observations and report to the maintenance team, if
upon inspection, the following is found:
1. Shipment is damaged, broken or tampered with
2. Shipment is dirty and manufacturer seals are not intact
3. Manufacturer shipment address does not match
4. Temperature sensitive products received are not within the storage
temperature limit.
5. Expired items are received
6. Handling, storage, service instructions or warnings are missing
 If any of the above findings are found, the storekeeper shall inform the
maintenance team which will process the observations and its impact on the
quality of the shipment and proceed further by taking action by reaching out to the
principle/manufacturer for recall (if applicable).
1. Quarantine label (Recalled Goods) will be fixed to each container
and they will be shifted to the quarantine area, if a recall is
required.
2. The shipment will be shifted to an isolated area and kept separate
from the rest of the stock.
 Once the storekeeper clears the shipment, the shipment will be unloaded in the
receiving area with the help of the drivers.
 The unloaded goods will be checked for:

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 1. Correct material name and quantity (as per placed purchased order
and challan/ invoice)
2. Correct Serial/Batch/Lot no’s
3. Gross weight and net weigh of the products box
4. Handling. Storage, warning and operating instructions
 The storekeeper shall generate a Goods Receiving Note after this procedure and
its copy will be given to the office department and maintenance team for record
maintenance. .
 Copies of all the purchase order requests and shipment documents will be retained
in the master data base (software and hardcopy)

REVIEW
 This policy shall be reviewed on an annual basis for any modifications and iterations
in the process.