Saudi Arabia Medical Device Regulations
Regulatory Authority: Medical Device Sector, Saudi Food & Drug Authority
Link for MoH: https://www.moh.gov.sa/en/Pages/default.aspx
Medical device definition: Means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article:
A. Intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purposes(s) of
– Diagnosis, prevention, monitoring, treatment or alleviation of disease,
– Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
– Investigation, replacement, modification, or support of the anatomy or a physiological process,
– Supporting or sustaining life,
– Control of conception,
– Disinfection of medical devices,
– Providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body;
B. Which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means.
Local regulation: Medical Device Interim Regulation
Classification: Medical devices
Local Listing or Registration: Medical Device Listing and Marketing Authorization are required. Medical devices shall comply with the regulations of one of the GHTF founding members (Australia, Canada, Japan, the USA, and the EU/EFTA) and additionally with “National Provisions and Requirements for Medical Devices” of Saudi Arabia. The application for listing and authorization is made using the new SFDA database GHAD. SFDA takes 35 working days to review the applications.
Medical device listing: Class A medical device excluding class As, class Am, class Ar can be authorized via medical device listing or medical device marketing authorization.
Medical Device Marketing Authorization (MDMA): Class B, Class C, and Class D medical devices can be authorized via the marketing authorization route.
Data to be communicated to GHAD:
- Label
- IFU/eIFU
- Conformance to Quality Management System (ISO 13485:2016) or other
- Declaration of Compliance with the Requirements of “Medical Device Interim Regulation
- Documentary Evidence of Compliance with the Relevant Regulatory Requirements Applicable in One or More of the Jurisdictions of Australia, Canada, Japan, the USA and the EU/EFTA or others.
Registrants have deadline of July 1, 2021 to open a new account in GHAD and shift all existing and in-process applications of medical devices to GHAD. After the date any applications which are not transferred will be cancelled.
Fees for application depends on the route and number of devices/accessories.
MDL: 500 SR/Application
MDMA:
30,000 SR/Application containing (1) to (5) medical
40,000 SR/Application containing (6) to (20) medical devices/accessories
50,000 SR / application containing (21) to (50) medical devices/accessories
7000 SR for Update MDMA
Validity: Validity of authorization is up to 3 years.
Who should make this communication:
- Manufacturer
- Authorised Representative
When to make this communication: Before placing a medical device into the Saudi Arabia market.
How OMC Medical can assist you with the process:
- Act as your authorised representative.
- Assist you with listing and authorization by filling in the form and registering the medical device with the GHAD.
Why Choose Us
- Working towards client satisfaction.
- Cost effective solutions.
- Project completion before deadline.
- Quality Regulatory affairs solutions.
Contact us for free consultation: [email protected]