By submitting this form, you are agreeing to the Terms of Use and Privacy Policy.
There are about 200 companies in Portugal that sell medical equipment. In Portugal, the public sector pays for more than of the costs associated with medical devices, while the private sector only purchases of all sales. Prices play a major role in all purchase decisions, whether they are made by the public or private sectors.
Surgery equipment, patient monitoring systems, minimally invasive surgery (MIS) equipment, noninvasive medical devices, video endoscopes, X-ray equipment, digital image processing, magnetic resonance imaging (MRI) equipment, and picture archiving systems have the greatest sales potential in Portugal.
Risk-based classifications for medical equipment include Classes I, IIa, IIb, and III. You must ensure that your medical device has received the CE mark before marketing it in Portugal.
This mark signifies compliance with current EU regulations and permits the device to be freely sold on the European market.
Although the requirements for registering Class I medical devices differ from those for registering Class IIa, IIb, III, and implantable active medical devices, all classes of medical devices entering the Portuguese market must still undergo the device registration process in addition to the CE marking.
Portugal medical devices market accounted for $XX Billion in 2023 and is anticipated to reach $XX Billion by 2030, registering a CAGR of XX% from 2024 to 2030.
The main objective of the Institute is to guarantee the efficacy, safety, and performance of pharmaceuticals as well as the performance, safety, and efficacy of healthcare products in order to minimise the risks associated with their use and to uphold appropriate standards for consumer and public health protection.
Regulation and oversight of pharmaceutical and healthcare products, from their development to use by patients and healthcare professionals, rank among Infarmed’s main activities.
Within the framework of the Network of Official Medicines Control Laboratories, Infarmed executes its competencies and duties as the National Competent Authority on Medicines and Health Products and as the Reference Laboratory on the Quality Control of Medicines at the national and European levels (OMCL).
The Institute pursues its activity at the national and European levels in a number of areas: the development, review, and approval of pharmaceuticals. Medication quality, safety, and effectiveness monitoring.Clinical trial Good Clinical Practices (GCPs).
Health product research, evaluation, registration, supervision, and monitoring. Clinical research evaluation, review and registration of medical devices with the CE mark, notice of health care items, and market oversight activities pharmaceutical activity licencing and inspection.
GMPs (Good Manufacturing Practices), GDPs (Good Distribution Practices), and GPPs (Good Pharmacy Practices) are the regulations that apply to each operator and are enforced through licencing, auditing, and inspection of manufacturers, wholesalers, and pharmacies.
Control of the quality of drugs and health items by collecting samples of drugs and health goods along the whole supply chain and analysing them at the laboratory of Infarmed.
