The beginning of the compliance business of Saudi medical devices indicates that a new module is added to SUNGO's global compliance business landscape.
SUNGO was already experienced in applying for MDMA for Chinese medical device manufacturers and successfully obtaining approval.
PART.1
Market background
As part of its 2030 Plan, Saudi Arabia is planning to expand its healthcare infrastructure. Saudi Arabia has a population of more than 36 million. Yet Saudi Arabia spends only around 5% of GDP on health care, compared with more than 10% in developed countries.
Saudi Arabia has invested heavily in healthcare in recent years and will continue to spend more, making itself an appealing market for medical device manufacturers. However, manufacturers who want to sell their devices in the country must first meet regulatory requirements, that is to say they must obtain authorization for their equipment in Saudi Arabia.
PART.2
Competent authorities and Legal system
2.1 Saudi Food and Drug Administration
Medical devices can only be marketed in Saudi Arabia if they are registered with the SFDA (Saudi Food and Drug Administration) and comply with the Interim Regulations of Medical Devices. It is responsible for the registration and monitoring of medical devices. SFDA regulates products including: drug, food, medical devices, cosmetics, feeds, tobacco, pesticides.
2.2 Legal system of medical devices
1）Basic regulations
"Medical Devices Law" No.(M/54) dated6/7/1442H
"Implementing Regulation of Medical Devices Law" No. (3-29-1443) dated19/2/1443
2）Series of requirements
3）Guide series
PART.3
Saudi Medical Devices Listing Compliance Process
Risk classification of medical devices
Medical devices and in vitro diagnostic devices exported to Saudi Arabia shall be classified according to the MDS-G-008 guidelines.
Classification of medical devices (excluding IVDs)
Classification of in vitro diagnostic devices
3.2 Compliance Process of medical device listing
The following diagram displays the framework of the Saudi regulatory framework for medical devices, which shows that manufacturers and authorized representatives are required to complete the MDMA review process, while the authorized representative is required to complete the MDNR registration.
As a Chinese manufacturer, the following steps should be followed to complete the pre-market compliance procedures for the device.
1) Appoint an authorized representative
Manufacturers without a registered office in Saudi Arabia are required to have an authorized representative (AR) in the country. An AR must be registered with the SFDA before submitting the medical device for
2) MDNR number
SFDA is responsible for maintaining Medical Devices National Registry (MDNR). The database lists all devices and companies in Saudi Arabia. Before the device is released to the market, the AR submits relevant information and gets an MDNR number.
3) QM system
Medical device manufacturers must have a QM system that complies with ISO 13485:2016. The corresponding certificate and the latest audit report of the designated institution must be submitted to SFDA.
4) Application of technical documents
Annex 3 and 4 of MDS-REQ 1 list the contents of technical documents for medical device products and in vitro diagnostic devices respectively. The content and format of technical documents refer to the relevant requirements of STED.
5）Online application of technical documents
6）Pay the application and review fees
7）The authority will review and issue a certificate after passing.
Special Concern 1: Since September 27, 2022, all categories of Medical devices shall be subject to Medical Device Marketing Authorization (MDMA). Products of Class A or other high risk products should meet the requirements of MDMA. The overseas manufacturer shall appoint a local authorized representative to conduct MDMA on behalf of them.
Special Concern 2: The SFDA has cancelled the MDMA GHTF path, through which medical devices could be approved when they are certificated or registered in the European Union, the United States, Canada, Australia and Japan. Now the manufacturer can only obtain permission through MDMA TFA (Technical File Assessment). This path requires manufacturers to prepare and submit technical documents for review, and the requirements for manufacturers are more stringent.
3.3 Registration Approval time
The approval time for MDMA is 2-3 months after submitting application materials, and the time will be longer for products with higher risks.
PART.4
SUNGOServices provided by SUNGO
SUNGO provides a full range of services to meet customers' needs of exporting medical devices to Saudi Arabia:
1) Provide training related to Saudi medical device regulations;
2) Provide consultation on classification of medical devices in Saudi Arabia;
3) Provide local authorized representative services in Saudi Arabia;
4) Provide the compilation service of MDMA review documents;
5) Provide testing services related to product testing in technical documents;
6) Provide corrective guidance for MDMA review process;
7) Provide technical services related to PMS.
SUNGO was already experienced in applying for MDMA for Chinese medical device manufacturers and successfully obtaining approval. The project took only one and a half months, during which SUNGO provided a full range of technical services.
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