MD approval in Saudi Arabia
Medical Device Registration and Approval in Saudi Arabia
Obtaining approval to sell your medical device or in vitro diagnostic device (IVD) in Saudi Arabia requires registration of your product with the country’s medical device regulatory authority, the Saudi Food & Drug Authority (SFDA). Medical device regulations in Saudi Arabia are based on the Global Harmonization Task Force (GHTF) requirements, and foreign manufacturers must have approval from at least one founding GHTF member (Australia, Canada, Japan, the European Union or the US) before registering with the SFDA. As a native Saudi regulatory affairs consultants, Alshedwy Group can fully support your medical device registration in the Kingdom of Saudi Arabia (KSA).
Device classification in Saudi Arabia
Classifications in the KSA are based on the classification within the founding GHTF country on which you’re leveraging your approval. How your medical device or IVD is classified in your GHTF reference market will determine how the Saudi FDA classifies your device in Saudi Arabia.
What is needed before a device registration can be submitted?
First, if you have no local presence in the KSA, you must appoint a Saudi Authorized Representative. Your Authorized Representative must obtain an Authorized Representative License, renewable on an annual basis, in order to legally represent you in the KSA. The Authorized Representative enrolls your device in the Medical Device National Registry (MDNR).
Submission of applications to the SFDA
Your Saudi Auth. Rep. is also responsible for submitting all application documents to the SFDA in order to register your device. All application documents are submitted via the Saudi Arabia’s Medical Device Marketing Authorization (MDMA) system.
Documentation necessary for SFDA submissions must be provided in English, and includes the following:
- Manufacturer and Saudi Auth. Rep. details
- Medical device information, such as intended use and labeling/instructions for use and all marketing materials
- Documents supporting your market authorization in your reference GHTF market.
- Statement confirming that the applicant will comply with the KSA’s National Centre of Medical Devices Reporting (NCMDR) requirement that any Field Safety Corrective Action affecting your medical device be reported to KSA authorities
Review Timelines and Certification Validity in Saudi Arabia
The SFDA allots 35 working days as its official timeframe for reviewing applications. Approvals for Class I devices and IVDs last for three years. For all other medical device classes, approvals are valid either for as long as your approval in your reference GHTF country or three years.
Please contact us at your convenience for a free consultation at: +966 502015100 or regulatory@alshedwygp.com