Sweden is a leading Nordic innovation hub with a highly advanced healthcare system, offering excellent opportunities for pharmaceutical, medical device, and biotech manufacturers within the EU/EEA single market.
The Swedish Medical Products Agency (Läkemedelsverket) is the national competent authority responsible for regulating medicines, medical devices, in vitro diagnostics, clinical trials, pharmacovigilance, and vigilance in Sweden. As an EU Member State, Sweden fully implements centralized procedures via EMA for medicines and MDR/IVDR for medical devices, with Läkemedelsverket managing national procedures, decentralized/mutual recognition procedures, Swedish language labelling requirements, and local compliance oversight. MedWisdom LifeScience provides expert regulatory affairs support to help global manufacturers navigate Sweden’s EU-harmonized framework efficiently, prepare compliant submissions (including Swedish labelling), secure timely approvals, and ensure long-term compliance in this premium, innovation-driven Nordic market.
Get Sweden Compliance Support
Expert CTD/eCTD dossier compilation, Module 1 Sweden-specific adaptation, scientific/technical review, and quality assurance for Läkemedelsverket/EMA submissions.
Complete management of national, DCP, MRP, and centralized submissions via Läkemedelsverket and EMA, including validation, follow-up, and query handling.
Preparation and submission of CTAs/CTIS applications to Läkemedelsverket, ethics committee coordination, and regulatory support for clinical trials in Sweden.
Swedish QPPV/local contact person services, PSUR/PBRER submissions to Läkemedelsverket/EMA, adverse event reporting, signal detection, and RMP maintenance.
CE marking support, Notified Body liaison, conformity assessment, vigilance reporting, and Läkemedelsverket registration/oversight compliance in Sweden.
PMS/PMSR implementation, trend reporting, FSCA notifications, vigilance compliance, and ongoing monitoring per Läkemedelsverket and EU requirements.
Swedish labelling review (including Swedish language requirements), Blue Box/EEA specifics, mock-ups, readability testing, and Läkemedelsverket approval support.
Support for post-approval changes, renewals, line extensions, and full lifecycle compliance with Läkemedelsverket and EMA/EEA standards.
Strategic consulting, optimal pathway selection (centralized/national/DCP/MRP), Läkemedelsverket scientific advice preparation, and up-to-date Swedish/EU regulatory intelligence.
Partner with Medwisdom for expert, efficient, and fully compliant regulatory support in Sweden — from Läkemedelsverket/EMA submissions and MDR/IVDR compliance to pharmacovigilance, Swedish labelling, and sustained Nordic/EU market success.
Contact Our Sweden Regulatory Experts