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Revisamos 10000 resultados en vivo para medical device registration and market surveillance y los redujimos a 3 opciones que parecen valer más la pena comparar primero.
Los temas más fuertes en esta lista son Regulatory Authority y Government Services.
Fuente: INFARMED, I.P. (Autoridade Nacional do Medicamento e Produtos de Saúde)
Descripción
Comprehensive regulatory services for the Portuguese market, including mandatory medical device registration under MDR/IVDR on the official INFARMED platform. The service covers market surveillance, authorization for clinical investigations, and the management of medical device vigilance to ensure compliance with national and European safety standards.
Ideal para
Statutory market entry, Regulatory compliance in Portugal, Clinical investigation authorization y Vigilance reporting
Valoración
Fuente: Health Sciences Authority
Descripción
Formal registration services for medical devices ranging from low-risk Class A to high-risk Class D. The service includes evaluation routes such as Full, Abridged, Expedited, and Immediate registration, alongside licensing for manufacturers, importers, and wholesalers to ensure legal compliance in the Singapore market.
Ideal para
Medical device manufacturers, Healthcare product importers, Regulatory compliance officers y Legal market entry in Singapore
Valoración
Fuente: Health Cluster Portugal (Health Portugal)
Descripción
A comprehensive catalogue of certification and regulatory services specifically curated for Portuguese medical device companies. There is a strong focus on emerging technologies, including Software as a Medical Device (SaMD), providing pathways for digital health innovation and compliance.
Ideal para
Digital health startups, Software as a medical device (SaMD), Industry networking y Innovation support
Valoración
| Comparar | Medical Device Registration and Market Surveillance | Medical Device Registration and Dealer Licensing | Medical Device Certification Services and SaMD Support |
|---|---|---|---|
| Fuente | INFARMED, I.P. (Autoridade Nacional do Medicamento e Produtos de Saúde) | Health Sciences Authority | Health Cluster Portugal (Health Portugal) |
| Descripción | Comprehensive regulatory services for the Portuguese market, including mandatory medical device registration under MDR/IVDR on the official INFARMED platform. The service covers market surveillance, authorization for clinical investigations, and the management of medical device vigilance to ensure compliance with national and European safety standards. | Formal registration services for medical devices ranging from low-risk Class A to high-risk Class D. The service includes evaluation routes such as Full, Abridged, Expedited, and Immediate registration, alongside licensing for manufacturers, importers, and wholesalers to ensure legal compliance in the Singapore market. | A comprehensive catalogue of certification and regulatory services specifically curated for Portuguese medical device companies. There is a strong focus on emerging technologies, including Software as a Medical Device (SaMD), providing pathways for digital health innovation and compliance. |
| Ideal para | Statutory market entry, Regulatory compliance in Portugal, Clinical investigation authorization y Vigilance reporting | Medical device manufacturers, Healthcare product importers, Regulatory compliance officers y Legal market entry in Singapore | Digital health startups, Software as a medical device (SaMD), Industry networking y Innovation support |
| Acción | |||
| Valoración |
Si quieres empezar con la opción más equilibrada, te recomiendo:
"Medical Device Registration and Market Surveillance de INFARMED, I.P. (Autoridade Nacional do Medicamento e Produtos de Saúde)."
Lo elegí porque As the official Portuguese regulatory body, INFARMED is the only authority that can authorize the legal placement of medical devices on the local market.