With the aim of controlling medical devices placed on the national market and the economic operators involved in their distribution chain, EU Regulation 2017/745 of the European Parliament and of the Council and Decree Law No. 145/2009 of 17 June establishes the rules concerning the placing on the market or putting into service of medical devices for human use and accessories to such devices.
According to the law, a "medical device" is any instrument, device, equipment, software, implant, reagent, material or other article intended by the manufacturer to be used on humans for one of the following specific medical purposes: diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of a disease. For example, orthodontic appliances, surgical masks, contact lens fluid, hygiene products and health products, among others, are medical devices.
In turn, 'accessory to a medical device' is any article which, without being a medical device in itself, is intended by its manufacturer to be used in conjunction with one or more such devices, to specifically enable the medical device(s) to be used for the intended purpose.
Medical devices and accessories may only be placed on the market in Portugal if they fulfil the following conditions:
a) They bear the CE marking,
b) have been subject to a conformity assessment;
c) Have been registered with INFARMED.
The labelling and instructions for use of any medical devices and accessories must be written in the Portuguese language. The marketing of medical devices in Portugal is subject to the following mandatory notifications:
Notification of the activity of wholesale distribution of medical devices
All wholesale distributors must comply with the registration of the entity with INFARMED, i.e. any natural or legal person integrated in the commercialisation chain that undertakes commercial actions is obliged to carry out this registration.
This registration must be carried out at least 60 (sixty) days before the start of the wholesale distribution of medical devices and their accessories in Portugal. After 60 days - without a reply from INFARMED - the entity is legally entitled to distribute medical devices in Portugal.
The notification of the exercise of the activity of wholesale distribution of medical devices is made on the INFARMED website - "Licensing Requests" - through the following link.
This notification must be accompanied by:
a) "Responsibility form" filled in and signed by the technical manager,
b) Copy of the contract of employment or provision of services of the responsible technician,
c) Copy of the qualification and curriculum vitae of the responsible technician.
Registration of medical devices
Individuals or legal entities engaged in the distribution of medical devices and their accessories in Portugal are obliged to register each of the products they are going to market on the INFARMED website.
The registration of medical devices and their accessories is carried out on the INFARMED website, through the following link.
All distributors of medical devices, who intend to operate in the national market, must enter their data on the platform for the notification of medical devices.
Entities must indicate the following information for each of the medical devices: manufacturer, authorised representative, designation, brand/model, etc.
It is an administrative offence with a fine from €2,000 up to 15% of the turnover of the person responsible for the marketing of medical devices in the national market, who does not comply with the mandatory notifications and registrations imposed by Portuguese and EU law.
The Department of Commercial and Corporate Law of Belzuz Abogados, S.L.P. - Portugal Branch (Pharmaceutical Area), have extensive experience in advising companies that distribute medical devices, both in the Infarmed on-line registration system of the manufacturer and of the medical devices and accessories.
Departamento Derecho Mercantil y Societario | (Portugal)
Belzuz Advogados SLP
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