Frequent hand washing and use of PPE during COVID-19 pandemic – what about skin care?
The potential issue with skin irritation and discomfort may soon play a deleterious effect on adherence to health officials guidelines by the general population.
Archive
Articles from our earlier site, kept so that existing links still work. They are not updated, and some describe rules or services that have since changed. For current information, use Briefings.
California toxic-free cosmetics act moves forward in state assembly
On May 14th, AB 2762, the Toxic-Free Cosmetics Act, was passed out by the California State Assembly Committee on Environmental Safety and Toxic Materials. If adopted, the Act would ban 12 chemicals from cosmetics placed in the California market.
EUDAMED status update
Updates continue to be issued from the European Commission concerning EUDAMED in light of the current COVID-19 pandemic. The latest information sets new expectations about the availability of modules and expected activity.
Medical Apps CE marking
CE marking indicates that your product has been assessed to meet EU safety, health and environmental protection requirements and that it can be freely traded within the European Economic Area (EU + EFTA countries). It is valid for products developed both inside and outside the EEA. It is required for all products, including software/apps, that fall under the definition of a medical device.
S87 – a new EU approved UV filter
According to this Regulation, UV filters are defined as “substances which, contained in the cosmetic sunscreen products, are specifically intended to filter certain UV rays in order to protect the skin from certain harmful effects of these rays”. Until the end of 2020, it is expected that a new UV filter will be approved in the European Union.
E-commerce and EU cosmetic regulation
We live on an era that all things are accessible with a simple click. We can buy almost anything on the internet, but are all things available safe or according to Regulations?
Medical Devices – Brazil Regulatory Framework
Brazil represents the biggest market for medical devices in South America. Selling and marketing medical devices in Brazil requires several actions and compliance with legislation and standards, which can be a complex process.
HEMA and DI-HEMA-TMHDC – new restrictions?
The Cosmetic Ingredient Review (CIR) Expert Panel has assessed the safety of Methacrylate ester monomers and concluded that they were safe as cosmetic ingredients, when used in nail enhancement products and labelled to avoid skin contact. Nevertheless, the CIR Expert Panel expressed concern regarding the strong sensitization and cross- or co-reactivity potential of these ingredients.
Medical Devices – U.S. Regulatory Framework
The Food and Drug Administration (FDA) is the authority regulating Medical Devices in the U.S., to ensure their safety and effectiveness. Medical devices are divided into three classes (I, II and III) and this classification defines the regulatory requirements for each device type.
Medical Devices – EU Regulatory Framework
Medical Devices and In Vitro Diagnostic Medical Devices have a fundamental role in saving lives by providing innovative healthcare solutions for the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease. The European regulatory framework ensures the safety and performance of medical devices and facilitates patients’ access to devices in the European market. To keep up with advances in science and technology, 2 new Regulations are replacing the 3 existing Directives in the coming years.