Medical Device Registration in Portugal
According to Article 11 of Decree-Law No. 145/2009 published on 17 June, 2009 and transposed into Portuguese law Directive No. 2007/47/CE of European Parliament and Council, ALL CLASSES of Medical Devices (Class I exempt) must be registered online with the national regulatory authority, INFARMED. If the Manufacturer is headquartered outside the European Union, the requirements under the Portuguese regulation must be completed by a legal representative in the Community or, European Authorized Representative (E.A.R.)
- Designation of an E.A.R.!
- Provide E.A.R. with relevant documentation (to be provided upon request)
- Documentation review
- Registration with INFARMED
Group Management (a new function in the database) allows select medical devices to be grouped independent of the date the medical devices were registered. Groups are never “closed” which allows for the addition or elimination of devices.
Different presentations of medical devices, for example different quantities or sizes, are considered only one medical device as there is no difference in their compounds or end usage.
It is ill-advised for third party commercial entities (Distributors) to register a manufacturer’s products for a number of reasons:
- The manufacturer relinquishes an essential part of his control over his product in Portugal by registering his devices through his distributor.
- If a manufacturer ever decides to end their relationship with their commercial distributor, he would be required to remove the product completely from the market until it is re-registered.
- A third party commercial entity will expect exclusivity, limiting the open distribution of the product.
Local Legislations, such as this one, are growing rapidly in Europe (Italy, Portugal, France, Greece, Latvia, Bulgaria and Croatia) and strengthen the need for a professional European Authorized Representative present at any time.Get in touch