Registration in Portugal
Upper class medical devices and certain IVDs must be registered online with the national regulatory authority, INFARMED - as per Decree-Law No. 145/2009 published on 17 June, 2009. For non-EU manufacturers, the requirements under the Portuguese regulation must be completed by the EU legal representative/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 common in Europe (Italy, Portugal, France, Greece, Latvia, Bulgaria and Croatia)
On 26 May 2021, Medical Device Regulation (EU) 2017/745 will repeal Medical Device Directive 93/42/EEC. Until EUDAMED database allowing registration at EU level is functional, current- Directive registration process will continue. Nevertheless, Member States might continue requesting a separate registration to their national database.
For more information on the mandatory pre-market CPNP notification of your cosmetic products, have a look here!
Food supplements may be subject to the requirements of the national registration as a pre-market authorization. For more information, contact us today!
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