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Description Operon Strategist is a Medical device consulting company for Saudi Arabia which provides regulatory guidance to various manufacturers in the healthcare industry to ensure the strategic development of these manufacturers. We serve our clients by providing turnkey services, system implementation, training, licensing, regulatory approvals and certifications. We provide the clients customized solutions to manufacturers looking to set up a world-class manufacturing unit.
Medical device Registration in Saudi Arabia requires previous approval in one of the following reference markets Australia, Canada, Europe, Japan, or the USA. Generally, your medical device or IVD classification in the reference market will determine how the SFDA classifies your device. Authorized person should be appointed in Saudi Arabia, as he must have authorized representative and must gain representative license, and renew it on annual basis, Submitting all document and application to the needed authority and represent you in Kingdom of Saudi Arabia.
Description Operon Strategist is a Medical device consulting company for Saudi Arabia which provides regulatory guidance to various manufacturers in the healthcare industry to ensure the strategic development of these manufacturers. We serve our clients by providing turnkey services, system implementation, training, licensing, regulatory approvals and certifications. We provide the clients customized solutions to manufacturers looking to set up a world-class manufacturing unit.
Medical device Registration in Saudi Arabia requires previous approval in one of the following reference markets Australia, Canada, Europe, Japan, or the USA. Generally, your medical device or IVD classification in the reference market will determine how the SFDA classifies your device. Authorized person should be appointed in Saudi Arabia, as he must have authorized representative and must gain representative license, and renew it on annual basis, Submitting all document and application to the needed authority and represent you in Kingdom of Saudi Arabia.
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