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How to Obtain Saudi Arabia Fda Certification?

How To Obtain Saudi Arabia FDA Certification 1

Problem statement 1

We received an order from a client in Saudi Arabia who is a local trader and has a physical store for skin care products. At that time, he needed to customize 5,000 6-in-1  microneedle rollers (SC425). The customized microneedle rollers were sold together with his skin care products. However, the microneedle roller belongs to the second-class medical device product and needs to obtain the local FDA certification before export.

Solution 1

After learning about this situation, we positively discussed it with clients and expressed our willingness to cooperate with them to solve problems. We submit materials to assist clients in applying for the local FDA.

Submitted material includes:

1. List of the products that will be shipped to Saudi Arabia and their models

2. Valid ISO certificate

3. Labels/artwork

4. European free sale certificate (if available)

5. CE and DOC

6. IFU and SDoC letters are to be signed and stamped from the manufacturer’s side and then authenticated by the chamber of commerce.

Result 1

It took our company about 5 months to prepare materials and apply for certificates, and finally got the approval of the local FDA. Konmison can export products to Saudi Arabia and has obtained the import rights of Saudi Arabia. After obtaining the import license, the client was very happy and finally started to place an order for 5,000 6-in-1 microneedle rollers(SC425), and the client needed to customize the packaging box and user manual. Our designers designed the client’s LOGO according to the client’s needs, and our colleagues helped to edit the English and Arabic bilingual user manual.

We confirm the details carefully to make clients satisfied.

Case SC425 001

Problem statement 2

After we produced according to the client’s requirements, all the boxes have been plastic-sealed. Before shipment, the client requires to print the barcode and exporter information on the package box34, and the label is not accepted by the local FDA. It means that packaging for five thousand products has to be unpacked before printing. This will be a time-consuming and not easy job.

Solution 2

At first, we asked the client if it is OK without plastic sealing, but the client said that the local people are reluctant to buy products without plastic sealing. We understood after communicating with the client and printed it according to the client’s request. We firstly purchased another printer, set the information required by the client, and then opened the plastic packaging of each product. Printed it in the appropriate position of the box, finally plastic-sealed 5,000 products again.

Result 2

The clients expressed their gratitude and hope to build a long-term cooperation relationship with us in the future.

Case SC425 002
Case SC425 003
Case SC425 004

Problem statement 3

After we finally packed all the products, the client requested to ship them by sea. The freight company requires that all the details of the product must be taken photos, including pictures of each angle, user manual, etc. In addition, Local customs clearance requires a lot of information, including the original CI and PL, CO certification, and SASO certification, and all materials need to be stamped and approved by the China Council for the Promotion of International Trade(CCPIT).

Solution 3

We were also very patient to help our client, find suitable institutions to apply for the SASO certificate, and get the seal of CCPIT. Finally shipped successfully. After that, we lend all original documents to clients for customs clearance by international express.

Result 3

The client was very satisfied with the successful customs clearance and received the goods, and is willing to cooperate with us for a long time.


Our company will try our best to help our clients solve problems. From applying for certificates to custom packaging to delivery and customs clearance, our company is very patient and sincere to solve problems according to client needs. clients are also very satisfied with our service and thank us. Our company hopes to cooperate with clients happily, and it is a win-win situation to achieve long-term cooperation with clients.

Case SC425 005
Case SC425 005
Case SC425 006
Case SC425 006

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