Canada The article describes the regulatory changes proposed by the Canadian authority and clarifies their potential impact on the market and all the parties involved. Table of Contents Health Canada, the country’s regulating authority in the sphere of...
China Under the general rule, combination products constitute a specific group of products consisting of both medicine (drug) and medical device. In such a case, both products (medicine drug and medical device) are supplied together and intended to be used together for a...
Asia The second article of the HSA series provides an in-depth review of the Singapore structure of the submission for marketing approval and the details about the product and manufacturing process it should contain. Table of Contents The Health Sciences...
switzerland The first article provides a brief overview of the Swiss legislation in the sphere of medical devices, and also describes in detail the recent changes thereto. Table of Contents Swissmedic, a Switzerland’s regulatory agency in the sphere of healthcare...
FDA The first article provides an overview of the approach applied by the FDA to applications for marketing approval for new medical devices in terms of determining their substantial equivalence to the products that are already present on the market. Table...
FDA The article describes in detail the way the medical device manufacturer may apply for exemptions from general reporting requirements, as well as the information to be included in the appropriate request. Table of Contents The Food And Drug Administration (FDA...
