The Medical Device Establishment License (MDEL) authorizes a company to establish facilities for the
local manufacture, storage, importation, and distribution of medical devices. Any entity operating a
medical device establishment in Saudi Arabia must obtain an MDEL from the Saudi FDA.
Regulatory Standards Assistance with MDEL
Offering regulatory guidance specific to MDEL requirements.
Assisting with documentation preparation tailored to MDEL applications.
Ensuring timely and accurate submission of MDEL license applications.
Handling communications with authorities regarding MDEL inquiries.
Guaranteeing adherence to MDEL regulations for successful licensing.
Service Details:
Timeline
1 - 2 Weeks
Validity
Annual
Saudi FDA Fees
SFDA fees depends of classification of company, the fees range is 5000 - 15000 SAR
