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"Pre-submission of Marketing Authorisation applications SMUH-AIM (Login) SMUH-AIM external user's manual (version 2, februrary 2014) Template - Declaration form for the use of e-mail communications with Infarmed - E-mail address identification form Summary of Actions - Manual SMUH-AIM (EN) Guidance to applicants - Submission of Marketing Authorisation Applications approved by Executive Board of INFARMED, I.P. Deliberation nr 186/CD/2013 (dated 24/10/2013) Credit card payment - Online portals for submission of marketing authorization and variation applications (SMUH-AIM e SMUH-ALTER) SMUH-AIM - Payments by credit card Eletronic pre-submission of MAA A new version of INFARMED¿s electronic portal for management of medicinal products for human use for pre-submission of MAA (SMUH-AIM) will be made available on October, 21st 2013. The new version of the electronic portal will allow pre-submission of marketing authorisation applications to INFARMED, I.P. by national and mutual recognition/dece..."

"Inserted in the plan to reform the IT architecture for information management of products regulated by INFARMED, IP, and together with the implementation of a repository of information on medical devices, was understood to be necessary to provide the process for registration of medical devices by its manufacturer/ authorized representative of a support that allows computerized on-line notification of medical devices and the computerized management of the entire process. Thus, the new registration system for Medical Device Manufacturers / Authorized representatives, aims to replace the previous registration procedures (some of which have been carried out not in electronic format, "on paper"). Under the new system were implemented a set of processes and features that are based on the activities inherent to the process of registration of DM / DIV by their Manufacturers / Authorized representatives addressing the legal requirements set out in European Directives and national legislation. A..."

"What is a medical device? What is a medical device?Any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of: Diagnosis, prevention, monitoring, treatment or alleviation of disease, Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, Investigation, replacement or modification of the anatomy or of a physiological process, Control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means. What are active medical devices? Any medical device operation of which depends on a source of electrical energy or any source o..."

"About Infarmed Human medicines Medical devices Cosmetics"

"The bookmarks feature lets you make a list of your favorite pages for quick access within the Infarmed website. Through this button, you can access your bookmarks by editing the displayed list, adding or removing the desired pages. To close this box, you can either click the "X" button or click anywhere on the page outside the Bookmarks box. After clicking the "Edit" button, you can change the sort order or remove pages from your Bookmarks. By pressing the "Sort" buttons, you can set the new sort order of your favorite pages. "Bookmarks" and "Add to bookmarks" buttons are available on all pages of the website (in the page header), regardless of whether or not the user is registered. Add pages Bookmarks feature lets you add the page where you are to your favorite page list. To do this, click the "Add to bookmarks" button. If the page is already on your list, this information will be displayed. Remove pages If you want to remove pages from your bookmarks list, you must open the form in e..."

"What is the regulatory framework for cosmetic products in Portugal? In Portugal cosmetic products are legislated by Regulation (EC) No 1223/2009, Deliberação n.º 15/CD/2013, Decree-Law n.º 189/2008, September 24th, as it stands, namely articles 10, 20, 22, 23, 24, 25, 29 as well as penalties applicable. What do I have to do to place a cosmetic product on the Portuguese market? Some elements of the cosmetic¿s labelling should be written in Portuguese, namely the nominal content, date of minimum durability, particular precautions to be observed in use and the function of the cosmetic product. In case your products are manufactured in Portugal you should also keep the following data: Name, qualifications, address and contacts of the qualified technician, established in the European Union, who is responsible for the products in terms of manufacturing, quality control, composition and packaging/labelling, according to the Articles 24 and 25 of the Decree-Law No. 189/2008, of September 2..."

"What is the definition of a in vitro diagnostic medical device (IVDD)? Under Decree-Law no. 189/2000 of 12 th August, transposing the Directive 98/79/CE, an IVDD is: any in vitro diagnostic medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system whether used alone or in combination, intended by the manufacturer to be used, in vitro , for the examination of samples derived from the human body with a view to provide information on the physiological or pathological states and congenital anomalies, to determine the safety and compatibility of potential recipients or monitor therapeutic measures; container(s) specifically designed by the manufacturer to contain or preserve samples derived from the human body intended for in vitro diagnosis; Who controls the medical devices placed on the market? The Portuguese Competent Authority acts on behalf of the government to ensure that Community Directives are implemented in ..."

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"Request for Regulatory and Scientific Advice of Cosmetic Products"

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"Infarmed is concerned about accessibility for people with special needs. For this reason, this portal has been revised to comply with the AA Level of the Web Content Accessibility Guidelines, version 1.0 (WCAG 1.0 - Web Content Accessibility Guidelines 1.0) and 2.0 (WCAG 2.0 - Web Content Accessibility Guidelines 2.0) Of the W3C - World Wide Web Consortium. The display of the Accessibility Symbol does not guarantee that this portal is fully accessible. The use of this symbol only demonstrates an effort to increase the accessibility of this portal in accordance with the Resolution of the Council of Ministers no. 155/2007 of October 2, 2007 on accessibility of public administration sites on the internet by citizens with needs Special conditions. Compliance with the standards allows us to have some additional functionalities, such as: Existence of alternative text for the images used, when relevant; Maintenance of most portal features even with inactive JavaScript; Formatting menus as lis..."

"What is the National Vigilance System of Medical Devices? The system includes an articulated set of rules and material and human resources, aimed at the systematic collection of information concerning medical devices safety use and their scientific evaluation, and foresees that, appropriate measures are taken to protect the health citizens, where justified. How is the National Vigilance System of Medical Devices? It consists of a structure that includes: a) The competent authority through their service responsible for medical devices vigilance; b) Manufacturers and authorised representatives; c) Distributors; d) The units and establishments, public or private provision of health care; e) Health professionals; f) Other users; g) Notified body where applicable. What are Infarmed duties in the National Vigilance System of Medical Devices? The Infarmed is responsible for the National System for Vigilance of medical devices having the following functions: a) Establish, develop and d..."