• Dealing with eye drops, hyaluronic acid and botox products


    Dears / Members of the Chamber


    Asharqia Chamber presents you with its best regards and informs you that it has received the letter of the Council of Saudi Chambers No. (42100802) and the date (25/2/1442), in which it is referred to the letter of the Food and Drug General Authority No. (4998 / P) and the date (2/21/1442), which contains The authority seeks to continuously develop product classification procedures, in order to support the product registration mechanism in accordance with scientific and regulatory classification standards, in order to achieve the safety and safety of the registered products, and in addition to Circular No. Ophthalmic, hyaluronic acid, and botox injections "for the products listed in the following table: 

    Normal Saline productsNasal Preparation
    Normal Saline productsEar Preparation
    Products that have direct contact with the eyesEye Preparation 
    Hyaluronic acid and botulinum toxin injectionInjection Product​​

    Whereas, the Authority informs about the product classification mechanism and its updated registration procedures, which are as follows:

    First: Classifying the above-mentioned products as pharmaceutical preparations (medicine) if they agree with the regulatory definition of the pharmaceutical preparation contained in the system of pharmaceutical and herbal facilities and preparations issued by Royal Decree No. (M / 108) dated (22/8 / 1441H), and have achieved the therapeutic, preventive or diagnostic effect intended by them Pharmacological, immunological or metabolic methods.
    Second: Classifying the above-mentioned products as medical products and devices (medical device) if the statutory definitions contained in the Medical Devices and Products Control Regulation approved by the Authority’s Board of Directors Decision No. (1-8-1429) dated (12/29/1429 AH) have fulfilled the intended purpose of their use. Non-pharmacological, immunomodulatory, or metabolic methods.
    Third: The authority provides product classification service for companies through the Electronic Product Classification System (PCS) to determine the supervisory path and the relevant sector for the product at the following link: (http://pcs.sfda.gov.sa).

    Sincerely Regard 


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