Local Regulatory Experts
Connect with regulatory affairs consultancies specializing in this region.
Qualtech Consulting Corporation
Taiwan, China, Japan, Singapore, Hong Kong, Malaysia, Philippines, Vietnam, Australia, Germany, Korea, Thailand, USA
A specialized medical device consulting firm offering a one-stop solution for complex global regulatory challenges. We offer real-time regulatory and clinical support, local representation, and QMS services across 13 markets, ensuring efficient market entry and compliance.
MedEnvoy Global
The Hague, Netherlands, London, United Kingdom, United States, Switzerland, Australia
A global regulatory compliance partner specializing in in-country representation (EC Rep, UKRP, CH Rep, US Agent) and independent importer services for medical device and IVD manufacturers. We help companies navigate complex regulations in Europe, the UK, Switzerland, and the US while maintaining supply chain flexibility.
KoBridge Co Ltd
Seoul, Korea, Lausanne, Switzerland
We offer fast, effective, and flexible solutions for medical device manufacturers needing to navigate the increasing complexity of global regulations. Their core competencies cover CE Marking, FDA 510(k)/PMA, MDSAP, and especially Korea MFDS registration and KGMP compliance. They handle active, non-active, combination, and animal-origin devices, providing services from strategic planning and dossier preparation to quality system implementation (ISO 13485) and audits.
Regulatory Compliance Associates Inc. (RCA)
Pleasant Prairie, WI, Tampa, FL
Regulatory Compliance Associates (RCA) is a leading global provider of regulatory and compliance expert consulting services for life science companies. The company offers expertise in regulatory affairs, assessments and audits, agency response, preparation and remediation, and new product development support for medical devices, pharmaceuticals, and compounding pharmacies.
May 2, 2025
Approximately 5 minutes
Registering Medical Devices with the BfArM: The National Notification Requirement
BfArM Notification: Germany's Mandatory Medical Device Registration
In Germany, the primary authority for medical device oversight is the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM). While compliance with the EU Medical Device Regulation (EU MDR) and obtaining the CE Mark grants access to the European market, Germany imposes a mandatory national step: BfArM Notification.
1. The Role of the BfArM
The BfArM serves as the national competent authority responsible for:
- Market Surveillance: Monitoring devices placed on the German market to ensure they meet safety and performance standards.
- Vigilance: Receiving and processing reports of serious incidents and Field Safety Corrective Actions (FSCAs) from manufacturers and the EU Authorized Representative (AR).
- National Registration: Maintaining the national register of medical devices until the central European database, EUDAMED, is fully operational and used uniformly.
2. Mandatory National Registration Steps
All manufacturers, including German ones, must notify the BfArM upon placing a device on the German market.
- Eligibility: The device must already have a valid CE Mark based on a Declaration of Conformity (Class I) or an EU Certificate (higher classes).
- Notification Requirement: Manufacturers must provide specific data to the BfArM, including the manufacturer's details, the device classification, and the details of the EU Authorized Representative (for non-EU companies). This notification must be made before the device is first distributed in Germany.
- Language Compliance: All user-facing documentation, most notably the Instructions for Use (IFU) and labeling, must be provided in the German language as part of national requirements for patient safety.
3. Vigilance and Post-Market Obligations
The AR plays a crucial role in maintaining German compliance post-market.
- Reporting: The AR must ensure that all serious adverse events occurring within Germany are reported promptly to the BfArM.
- PMS Maintenance: Ongoing adherence to the device’s Post-Market Surveillance (PMS) plan and submission of Periodic Safety Update Reports (PSURs) ensure the device's long-term safety profile is monitored and communicated to the German authority.
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Approximately 5 minutes
Medical Device Registration in Germany: BfArM Notification and EU MDR Requirements
Selling medical devices in Germany requires full compliance with the **EU MDR**, the presence of a **CE Mark**, and mandatory national notification with the **BfArM**. Non-EU manufacturers must designate an **EU Authorized Representative** and ensure all device documentation and labeling are provided in German.
Approximately 5 minutes
The Two-Step Process: CE Marking and Mandatory BfArM Registration for German Market Access
To sell medical devices in Germany, manufacturers must first secure the **CE Mark** (Step 1) and then complete mandatory national registration with the **BfArM** (Step 2). This two-step process requires an **EU Authorized Representative** for non-EU companies and adherence to German language requirements.
Approximately 5 minutes
Germany's Unique Regulatory Landscape: National Requirements Beyond EU MDR
Selling medical devices in Germany requires full **EU MDR compliance** and **CE Marking**, but also mandates additional national steps, including **BfArM notification**, enhanced **documentation standards**, and strict adherence to **German-language requirements** for all user and patient-facing materials.