In 2016 UNITIS, an Organization of Cosmetics Ingredients Industries and Services, launched the NCS TOX Project to boost knowledge of natural substances.
News
(P) Steps to obtain CE Marking for your PPE 89/686/EEC Directive Products
Develop a roadmap towards obtaining a CE mark and compliance program for your PPE with Obelis' European Authorized Representative services.
The importance of GMDN Codes
According to the European Commission decision from 19th April 2010, uploading data into EUDAMED requires the use of GMDN codes. Read more on this topic.
New EU Borderline and Classification Manual on Medical Devices
A manual has been published on borderline products and classification under EU medical device regulation 2017/745. It contains guidance on harmonised standards.
New European Notified Body Product Codes Open for Consultation
Public consultation has been opened on the implementation of the new notified body product codes under the oncoming EU medical device and IVD regulations.
Switzerland harmonizes Cosmetics Regulation with EU’s
Under Project LARGO, Switzerland has overhauled its food and consumer product regulations, harmonizing them with current EU laws and standards.
Revised guideline on first- in-human clinical trial
From February 2018, new guidelines will enter into force on in-human clinical trials. Talk to Obelis about the implications this may have for your products.
Upcoming changes in Medical Devices Regulation in Australia
A number of changes have been made to Australian medicines and medical devices regulations to improve consumer access and remove red tape for manufacturers.
Do cosmetics sales on the Internet need to follow EU rules?
Do cosmetics products sold online need to comply with EU regulations? Of course! Products sold online within the EU are fully covered by all EU regulations.
Are E-Cigarettes regulated as Medical Devices ?
Electronic cigarettes work by heating up a liquid until vaporization is reached. This is essentially another way of putting nicotine into your body. How are electronic cigarettes being regulated under the EU Law ? Are these to be considered as tobacco products or something else ? Read more on this topic