Exporting medical devices to Gulf countries

In Gulf countries, the export of special equipment such as medical devices (including food, electrified products, cosmetics, and other liquid products) requires separate certification applications from the exporting countries

Pre certification application process for exporting medical devices to Saudi Arabia

The medical device market in Saudi Arabia is regulated by the Saudi Food and Drug Authority (SFDA), and obtaining SFDA certification is one of the basic requirements for legally selling medical devices in the Saudi Arabian market.

https://www.sfda.gov.sa/en  

1) Designated authorized representative

Manufacturers without registered offices in Saudi Arabia need to have an authorized representative (AR) in the country. AR must be registered with SFDA before submitting medical devices for authorization.

2) MDNR Number

SFDA is responsible for maintaining the Online Medical Device National Registry (MDNR). This database lists all devices and companies located in Saudi Arabia. Before the device is launched on the market, AR will submit relevant information and assign an MDNR number.

3) QM system

Medical device manufacturers must have a QM system that complies with the ISO 13485:2016 standard. The corresponding certificates and the latest audit report of the designated institution must be submitted to the State Food and Drug Administration.

4) Technical document declaration

Annex 3 and Annex 4 of MDS-REQ 1 respectively list the contents of technical documents for medical device products and in vitro diagnostic devices. The content and format of technical documents are generally in accordance with the relevant requirements of STED.

5) Online declaration of technical documents

6) Payment application and review fees

7) Upon approval by the authorities, a certificate will be issued

Note: Starting from September 27, 2022, all categories of medical devices should go through the MDMA (Medical Device Marketing Authorization) channel. Both Class A and other high-risk categories of products should comply with the requirements of MDMA. Overseas manufacturers should appoint local authorized representatives to register MDMA on behalf of the manufacturer.

Dubai Arab Health Medical Equipment Exhibition

In addition, there is an annual Arab Health medical equipment exhibition held in Dubai, United Arab Emirates

https://www.arabhealthonline.com/en/Home.html (Official website), the next exhibition will be held from January 27th to January 30th, 2025

Pre certification application process for exporting medical devices to the United Arab Emirates

Medical device exports to the UAE: In the UAE, medical devices and in vitro diagnostic medical devices are regulated by the Drug Control Department under the Ministry of Health and Prevention (MOHAP).

1. Before starting registration in the United Arab Emirates, it is necessary to find and appoint a local representative (referred to as the Agent in the UAE) to act as a communication bridge between the manufacturer and the MOHAP authorities. At the same time, local representatives play a very important and irreplaceable role in the United Arab Emirates, which is the applicant for import permits. Only through local representatives can the application and issuance of import permits for products after obtaining certification be carried out

2. The product classification of medical devices requires submission of registration classification confirmation to the UAE authorities MOHAP before registration

3. If your medical device is determined to enter the UAE without registration, your local representative will need to apply for an import permit from the MOHAP authority to obtain valid credentials in the trade export process, in order to ensure the smooth entry of the product into the UAE. If your medical device needs to be registered, you can follow different registration paths based on the classification confirmation letter from the authorities