Asia
The article provides an overview of the existing regulatory framework for submissions related to healthcare products. Table of Contents The Health Services Authority (HSA), Singapore’s regulating authority in the sphere of healthcare products, has published a guidance...
Europe
The article describes the approach to be applied when determining the regulatory status of a borderline product that could be subject to regulation under the medical devices framework, and also pays special attention to the applicable risk-based classification. Table...
Europe
The new article highlights aspects related to changes to medical device registration and also describes in detail the public register of medical device manufacturers. Table of Contents The Medicines and Healthcare Products Regulatory Agency (MHRA), the UK regulating...
Europe
The new article addresses the aspects related to special types of products, as well as to the online registration system to be used and the approach to be applied when renewing the registration. Table of Contents The Medicines and Healthcare products Regulatory Agency...
Europe
The new article highlights aspects related to the information to be included in the submission in order to ensure its completeness. Table of Contents The Medicines and Healthcare Products Regulatory Agency (MHRA), the UK regulating authority in the sphere of medical...
