Norway is a highly attractive Nordic market for pharmaceuticals, medical devices, and life sciences products, known for its advanced healthcare system, strong emphasis on innovation, and access to the EEA/EU single market.
The Norwegian Medical Products Agency (NOMA, Direktoratet for medisinske produkter) is the competent authority responsible for regulating medicines, medical devices, and related health products in Norway. As part of the EEA, Norway fully implements EU regulations including the centralized procedure via EMA for medicines and MDR/IVDR for medical devices, with NOMA handling national aspects, clinical trials, pharmacovigilance, vigilance reporting, and market surveillance. MedWisdom LifeScience provides expert regulatory affairs support to help foreign manufacturers navigate Norway’s aligned yet nationally administered requirements, secure efficient approvals, ensure compliance with EEA/EU standards, and achieve successful market entry and long-term sustainability in this high-value Nordic market.
Get Norway Compliance Support
Expert compilation, scientific review, and optimization of CTD/eCTD dossiers for national, MRP/DCP, and centralized procedures via NOMA/EMA.
Full management of submissions to NOMA and EMA, including variations, renewals, and query responses for medicines and devices.
Preparation and submission of CTAs/CTIS applications, ethics committee coordination, and regulatory support for clinical trials in Norway.
Local QPPV support, PSUR/PBRER submissions, adverse event reporting to NOMA, signal detection, and risk management in Norway.
CE/UKCA marking support, Notified Body liaison, conformity assessment, vigilance reporting, and NOMA registration/oversight compliance.
PMS/PMSR plans, trend reporting, FSCA notifications, vigilance compliance, and ongoing monitoring per NOMA and EU requirements.
Norwegian labelling review (including Bokmål/Nynorsk where required), Blue Box/EEA specifics, mock-ups, and readability testing.
Support for post-approval changes, renewals, line extensions, and full lifecycle compliance with NOMA and EMA/EEA standards.
Tailored strategic advice, pathway selection (centralized/national), NOMA liaison, and up-to-date intelligence on Norwegian/EEA regulations.
Partner with Medwisdom for expert, efficient, and fully compliant regulatory support in Norway — from NOMA/EMA submissions and MDR/IVDR compliance to pharmacovigilance, lifecycle management, and sustained Nordic market success.
Contact Our Norway Regulatory Experts