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MDCG Guidance on Borderline Between Medical Devices and Medicinal Products: Herbal Products
The new article describes in detail the regulatory status of herbal products.
The new article describes in detail the regulatory status of herbal products.
The article outlines the key points related to the regulatory framework for borderline products.
The new article further describes the applicable regulatory considerations, paying additional attention to the key concepts used in the context of borderline products in order to ensure the relevant regulations are applied properly.
The new article further elaborates on the requirements related to importation of medical devices, and also explains the way adverse events should be handled.
The new article describes the approach to be followed when it comes to the way the assessment process should be managed, as well as the matters related to marketing authorization and quality audits products should undergo in order to be allowed for marketing and use in the country.