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Nous avons examiné 10000 résultats en direct pour medical device registration and market surveillance et retenu les 3 options qui semblent les plus utiles à comparer en premier.
Les thèmes les plus forts dans cette sélection sont Regulatory Authority et Government Services.
Source: INFARMED, I.P. (Autoridade Nacional do Medicamento e Produtos de Saúde)
Description
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.
Idéal pour
Statutory market entry, Regulatory compliance in Portugal, Clinical investigation authorization et Vigilance reporting
Évaluation
Source: Health Sciences Authority
Description
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.
Idéal pour
Medical device manufacturers, Healthcare product importers, Regulatory compliance officers et Legal market entry in Singapore
Évaluation
Source: Health Cluster Portugal (Health Portugal)
Description
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.
Idéal pour
Digital health startups, Software as a medical device (SaMD), Industry networking et Innovation support
Évaluation
| Comparer | Medical Device Registration and Market Surveillance | Medical Device Registration and Dealer Licensing | Medical Device Certification Services and SaMD Support |
|---|---|---|---|
| Source | INFARMED, I.P. (Autoridade Nacional do Medicamento e Produtos de Saúde) | Health Sciences Authority | Health Cluster Portugal (Health Portugal) |
| Description | 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. |
| Idéal pour | Statutory market entry, Regulatory compliance in Portugal, Clinical investigation authorization et Vigilance reporting | Medical device manufacturers, Healthcare product importers, Regulatory compliance officers et Legal market entry in Singapore | Digital health startups, Software as a medical device (SaMD), Industry networking et Innovation support |
| Action | |||
| Évaluation |
Si vous voulez commencer par l'option la plus équilibrée, je vous recommande :
"Medical Device Registration and Market Surveillance de INFARMED, I.P. (Autoridade Nacional do Medicamento e Produtos de Saúde)."
Je l'ai choisi parce que As the official Portuguese regulatory body, INFARMED is the only authority that can authorize the legal placement of medical devices on the local market.