Last week, between 24 and 26 November, the 5th International Health Regulation Meeting was held. This is a global congress where regulatory experts and state health agencies from all over the world discuss current issues in the sector. Mercè Camps participated in a panel discussion on the regulation of medical devices in the EU.
The 5th International Meeting on Health Regulation has been organised by AMEPRESThe Mexican Association of Professionals in Health Regulation of the Health Inputs Industry (Asociación Mexicana de Profesionales en Regulación Sanitaria de la Industria de Insumos para la Salud).
Because of its international vocation, the following were invited to participate national health agencies -including the AEMPS - and a large number of health regulation experts from the following countries: Argentina, Brazil, Canada, Chile, Colombia, Costa Rica, Cuba, Dominican Republic, Ecuador, El Salvador, Guatemala, Honduras, Mexico, Nicaragua, Panama, Peru, Spain, Switzerland, United Kingdom, United States and Dominican Republic.
The meeting was informed about the main changes in the regulatory framework for medicines and medical devices -health products - in Latin America. In addition, it was announced that the actions of participating health authorities in combating the COVID-19 pandemic. It also discussed the importance of - "counting onn regulatory policies and smart regulatory systems"The participants also discussed how to make the regulatory processes more efficient. And finally, there was a discussion on the harmonisation, convergence and relianceand on the importance of these three concepts in order to make it possible to implement the smart regulatory systems.
International guest speakers included Mercè Campsdirector of Technical Pharmaceutical Officewho participated in a panel discussion on the regulation of medical devices in the EU.
Spanish representation at the international meeting
The 5th International Meeting on Health Regulation The meeting was attended by two participants who are experts in health regulation in Spain: a technician responsible for AEMPSand the director of our office Mercè Campswho participated in two of the scheduled events:
- Directed a round table on the new European Regulation on Medical Devices.
- Participating in another round table discussion on the policies being taken in relation to COVID-19.
From GTF, we value very positively the two interventions of our director, Mercè Camps, which allowed to solve before a huge audience -mainly composed of regulatory technicians from Central and Latin America- some doubts about the regulation of medical devices in the Eurozone.
A lecture on the regulation of medical devices by Mercè Camps
These were the topics discussed during the round table led by Mercè Camps at the meeting:
Part 1: New Regulation 745/2017 on Medical Devices:
- What we mean
- Definition
- Objectives of the Regulation
- Legislative Framework for Medical Devices
- Classification of Medical Devices
- What's new in the Regulation?
- Economic Actors
Part 2: CE marking
- Medical devices and CE marking
- Affixing the CE marking
- Implications of CE marking
- CE marked products
- Harmonised standards in the European Union
- Notified Body
- Accreditation Documents
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