A number of changes have been made to Australian medicines and medical devices regulations to improve consumer access and remove red tape for manufacturers.
News
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
Newly defined devices under the IVDR
New EU regulation shifts in-vitro device classification from list-based to risk-based, allowing for greater innovation and scope for manufacturers in Europe.
What is the CE Marking Process?
The Obelis' team break down and explain the European CE marking process and the steps required in obtaining a CE mark for a product or device on the EU market.
EU Vote on First Borderline Decision Confirms: Cranberry Products Are Not Medical Devices
EU vote confirms cranberry products are not medical devices. This is the first borderline product ruling adopted based on MDD 13(1)(d).
Should I work with my importer to register my cosmetic products?
EU regulations require a European Responsible Person be designated for products to be registered and placed on the EU market by any non-EU manufacturer.
Fragrances under scrutiny
Several Opinions were recently issued by the Expert Committees in regard to the use of fragrances in cosmetic products, as serious concerns were raised over their allergenic potential.
Transition of Notified Body from NB0434 and NB0470 to DNV GL Nemko Presafe NB2460
DNV GL Nemko Presafe NB2460 began operating in May 2017, a merger of former Norwegian notified bodies DNV GL Business Assurance Norway and Nemko AS NB 0470.
New limits for BPA in toys
New EU Commission Directive 2017/898 is set to enforce higher restrictions on Bisphenol A (BPA) in toys in the interest of consumer safety in Europe.