SASO CoC (Certificate of Conformity) and CAP (Conformity Assessment Program) are two particular Conformity Assessment routes that are allowing manufacturers worldwide to enter the market of Saudi Arabia with their products. This is in order to ensure some key objectives such as: Protection of public health, Consumer safety, National security, Protection of religious and public morals and environment, Prevention of deceptive practices.
How can a manufacturer decide on the classification of their electronic cigarettes?
Find out how E-cigarettes need to be regulated in the EU Market.
Post-market surveillance requirements are strengthened under new EU medical device regulation 2017/745. Find out what implications it has for your device.
Learn more about the objectives and main amendments of new EU Waste if Electric & Electronic Equipments regulation 2012/19/EU.
In order to protect public health, shipments of goods of medical interest imported from third countries and arriving at the international entry points of the Italian territory are subject to controls by the National Medical Authority.
Read more on this topic here.
Belgian medical and in-vitro diagnostic competent authorities merged in September 2017 for increased surveillance and traceability in devices on the EU market.
Exploring the differences and between medical and well-being apps under the scope of EU medical device regulation 2017/745 and their legal requirements.
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.
A manual has been published on borderline products and classification under EU medical device regulation 2017/745. It contains guidance on harmonised standards.
Public consultation has been opened on the implementation of the new notified body product codes under the oncoming EU medical device and IVD regulations.