On 6 February, the Spanish Agency for Medicines and Health Products published its AEMPS Quarterly Bulletin on Medical Devices and Cosmetics. This is the issue corresponding to the October–December 2016. It is a summary of the Agency’s activities, which has been published regularly for the past few months, and which is of great interest as it is an official source of information on our sector. Here at GTF, we recommend consulting these reports, as the Agency is the main public regulatory body for cosmetics and medical devices. As such, everything it publishes is official in nature and affects us in one way or another.
AEMPS Quarterly Bulletin: Medical Devices
For those who decide to follow our advice, this latest Quarterly Bulletin contains a number of news items of interest regarding medical devices. In the area of legislation, the publication discusses the update to the Clinical Evaluation Guidelines, the MEDDEV Guidelines, at European level. Under ‘Surveillance and Control’, there is a list of all the notices issued by the AEMPS regarding medical devices during that quarter. And in the ‘Other Information of Interest’ section, details on the Second Meeting of the agency’s Medical Devices Committee. There is also a range of information on IT applications in the medical devices sector and the sector’s involvement in scientific and public awareness activities.
AEMPS Quarterly Bulletin: Cosmetics
With regard to the cosmetics sector, the ‘Legislation’ section lists the latest publications of new versions of regulatory documents, all of which relate to the Declaration of Conformity. Under ‘Monitoring and Control’, reference is made to Rapex alerts and a list is published of the 17 cosmetic products withdrawn during the last quarter of 2016. In this regard, we would like to remind you that GTF has drawn up a annual report on European alerts. And finally, under ‘Other information of interest’, there is a discussion of the European Commission’s report on the safety of tattoo inks and permanent make-up.