The Portuguese Health Products Directorate (Infarmed – Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.) announced this week that the new national Decree-Law 145/2009 transposing the European Directives for medical devices (Dir 93/42/CEE and 90/385/CEE) came into force as of March 21st 2010.
Infarmed alerted the fact that Decree-Law No. 145/2009 of June 17th and regulation No 515/2010 and No 516/2010 of March 3rd, came into force on 21 March 2010.
The new diploma includes some new national requirements such as: as of March 21st 2010, companies operating within the Portuguese territory (national manufacturers and distributors) are required to make a notification of their activity to the competent authority (this is not related to the notification of medical devices already implemented since 2003). The regulation No 515/2010 and No 516/2010 defines the elements to be attached to the activity notification to be submitted to INFARMED, I.P..
Additionally, Infarmed alerted to the fact that Decree-Law No. 145/2009 of 17 June and regulation No 514/2010 of March 3rd came into force on 21 March 2010.
The regulation No 514/2010 is related to clinical investigation on medical devices: When a clinical investigation on medical devices is to take place in Portugal, the manufacturer or his authorized representative is required to submit to the Portuguese Competent Authority for medical devices, INFARMED, I.P., the clinical investigation notification which consists of several documents. One of the requested documents is of course the Ethical Committee Approval. In order to receive a favourable opinion from the Ethical Committee, the manufacturer must complete an application to the Ethical Committee as defined by the regulation No 514/2010 on the elements that should be attached to the aforementioned application.