The Experienced Regulatory Affairs Person Can Only Create Road Map of A Product!!!
Registering the product is a one-time task, but you must always keep its technical information on hand to train your team effectively.
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Regulatory Affairs
Establishment License (SFDA)
Medical Device Registration
Cosmetics Registration
Herbal & Health Product Registration
Food Product Registration
Saber Product Registration
Warehouse Registration
Scientific Office Registration
Basic Graphic Design
(Product Artwork)
Establishment License (SFDA)
This is the first step to start registration in Saudi FDA official portal. It needs descriptive information about the nature of the present and future upcoming products. While registering the Establishment or a Company we have to keep a list of task in front of us to get the actual registration what we are looking for! Otherwise, the one wrong selection can easily make cases worse for future business.
Medical Device Registration
Medical Devices are classified in different ways. Presently, Saudi Arabia is dealing with one platform for all Medical Devices and Establishment Registration process. If you an old or new concept product(s) in your hand and that product is registered in SFDA approved jurisdictions you are 90% at safe side. However, the registration process will be carried out as per product classification (Low-Risk or High Risk). Â
Cosmetics Registration
The cosmetics product registration is a little undergoes by two steps.
1. Supplier RegistrationÂ
2. Product Registration
The document submission is required as per the country of origin requirements. The SFDA is not so much strict in it but the sequence of the required documents is very important.Â
Herbal & Health Product Registration
The Herbal & Health product has quite a long registration process as compared to the Medical Device and Cosmetics. It needs complete documents from the Manufacturer Quality Certificate to the Product Quality. This process starts after getting a final letter from the Product Classification System. Â
Food Product Registration
The food product registration has two ways. Fresh Food Products and Synthetic Food Products. Both have different requirements as per HS Code and the difference in time of getting registrations. The process of registration of food products is not as complicated as others are!
Saber Product Registration
All other products registration (Expect SFDA Products) will be carried out with SABER. This registration process is making sure of the quality standards of the products and issuing certifications if not available priorly with the product from country of origin.Â
Warehouse Registration
The Warehouse Registration is carried with the online system as per Warehouse product nature (Medical or Non-Medical)! The Medical Warehouse is moving with two steps registration (Primary and Final). Both registrations will be followed by the inspections of SFDA and standards are quite strict for approvals. If you hired me a consultant I can give you a fast process of registration with the creation of the SOPs for each process.Â
Scientific Office Registration
The Scientific Office registration process will start after the final registration and post-market surveillance report from Saudi Arabia Territory. This process is highly appreciatable if a product is sharing its benefits to the local community. Â
Basic Graphic Design
The product registration process is quite a time-consuming process. However, it is converting into more time consuming when anyone is hiring a third party designer. This skill is accelerating the product registration by 50%! The speed ratio of my product registration is 85% and all functions are performed by me are time saving and productive. “IF NO TIME-SAVING IN REGISTRATION, MEANS WASTAGE OF MONEY”.