Saudi Arabia
Saudi Arabia
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:
Medical device
– 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;
– 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;
Local regulation: Medical Device Interim Regulation
Classification: Medical devices
Saudi Arabia Medical Device Regulations - omcmedical.com
IVD
IVD Saudi Arabia - omcmedical.com
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.
Classification: Medical devices
Saudi Arabia Medical Device Regulations - omcmedical.com
IVD
IVD Saudi Arabia - omcmedical.com
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: info@omcmedical.
Quick Contact
If you have any questions or need help, feel free to contact with our team.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Quick Contact
If you have any questions or need help, feel free to contact with our team.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Quick contact
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0044 7719761764
0044 2080667260 - Planet House, North Heath Lane, Horsham, West Sussex RH12 5QE
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
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To launch a medical device in a country, medical devices must comply with the local country’s regulatory requirements. Let us be your trusted partner in bringing your medical devices to the Global market. Contact us today to learn more about how we can assist you in every step of the way.
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