Disinfectants and sanitizers in most jurisdictions are viewed by regulatory authorities as three categories of products:
Regulatory authorities in different countries pursue different approaches to those three categories of products for disinfection, cleaning and sterilization.
Disinfectants and sanitizers in most jurisdictions are viewed by regulatory authorities as three categories of products:
Regulatory authorities in different countries pursue different approaches to those three categories of products for disinfection, cleaning and sterilization.
In the European Union disinfectants and sanitizers are deemed to be medical devices only if they are intended specifically to be used for disinfecting or sterilizing other medical devices. Hand sanitizers and products for general disinfection do not fall within the provisions of Regulation EC 2017/745. Such products are viewed by European regulatory authorities as biocides and are regulated by Regulation EC 528/2012.
In the USA disinfectants and sanitizers for general disinfection and products used for disinfection of medical devices belong to the category "Surgical and Infection Control Devices". Such products are considered in the USA as medical devices and are controlled by the FDA. While hand sanitizers are viewed by the FDA as OTC medicinal products.
In Mercosur countries disinfectants and sanitizers belong to a special category of products. The regulations applicable to them are similar to medical device regulations. Mexico practices the same approach.
In the European Union disinfectants and sanitizers are deemed to be medical devices only if they are intended specifically to be used for disinfecting or sterilizing other medical devices. Hand sanitizers and products for general disinfection do not fall within the provisions of Regulation EC 2017/745. Such products are viewed by European regulatory authorities as biocides and are regulated by Regulation EC 528/2012.
In the USA disinfectants and sanitizers for general disinfection and products used for disinfection of medical devices belong to the category "Surgical and Infection Control Devices". Such products are considered in the USA as medical devices and are controlled by the FDA. While hand sanitizers are viewed by the FDA as OTC medicinal products.
In Mercosur countries disinfectants and sanitizers belong to a special category of products. The regulations applicable to them are similar to medical device regulations. Mexico practices the same approach.
MDRC assists manufacturers of disinfectants and sanitizers with regulatory approvals and placing their products on the European, USA and Latin American markets - regardless of the products' composition and intended use. We will help you figure out which standards are applicable to your products and bring your technical documentation, quality system etc. into compliance with regulatory requirements of your strategic markets.
MDRC assists manufacturers of disinfectants and sanitizers with regulatory approvals and placing their products on the European, USA and Latin American markets - regardless of the products' composition and intended use. We will help you figure out which standards are applicable to your products and bring your technical documentation, quality system etc. into compliance with regulatory requirements of your strategic markets.
We will put your medical devices on your strategic markets in a timely and cost-efficient manner. MDRC are experts on all types and classes of medical devices. Entrust your regulatory affairs to the professionals.
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