Global Product Registrations & Approvals for Medical Devices and IVDs
Technical documentation is crucial for securing regulatory submissions and approvals. While the format may vary between jurisdictions, the purpose remains the same: to demonstrate the safety, performance, and compliance of the medical device.
GBA Key2Compliance, assist you to achieve CE marking for your device to access the EU market. We process FDA submissions, including 510k, PMA and De Novo, and support global registration of your medical device or IVD product.
Successfully navigating global product registrations and approvals requires a thorough understanding of both the technical and procedural requirements of each target market. Each regulatory authority, whether in the European Union, the United States, or other jurisdictions, has its own unique expectations regarding documentation, testing, labeling, and clinical evidence.
Our experts help you streamline submissions and secure approvals – ensuring faster, safer access to global markets. Contact us to get started.
Processes for different market areas
European Union
For the European Union, achieving CE marking involves not only compiling a complete and well-organized technical file but also engaging with a Notified Body to assess conformity with the applicable MDR or IVDR.
This process may require a combination of desktop reviews, on-site audits, and, where necessary, performance evaluations or clinical investigations. Manufacturers must be prepared to respond promptly to queries and provide supplementary data to address any outstanding issues.
USA
In the United States, the FDA demands a tailored approach depending on the classification and risk profile of the device. The 510(k) premarket notification process relies on demonstrating “substantial equivalence” to a legally marketed predicate device, while the Premarket Approval (PMA) pathway requires more extensive clinical data to support claims of safety and effectiveness.
The De Novo process offers an option for novel devices lacking a suitable predicate, emphasizing the importance of a robust risk assessment and, often, additional clinical or performance studies.
Rest of the World
Beyond the EU and US, many countries in Asia-Pacific, Latin America, the Middle East, and Africa are evolving their regulatory frameworks, drawing from international standards such as ISO 13485 and the Medical Device Single Audit Program (MDSAP).
Some markets may require local representation, in-country testing, or language-specific labeling and documentation. Proactively monitoring regulatory changes and anticipating new requirements is essential to preventing costly delays and ensuring uninterrupted market access.
Save time and resources
A successful global registration strategy hinges on early planning, cross-functional collaboration, and a commitment to regulatory intelligence. By leveraging the expertise of regulatory professionals, manufacturers can streamline their submissions, anticipate challenges, and respond efficiently to requests from authorities. Comprehensive project management, clear timelines, and a flexible approach further support timely approvals, allowing companies to bring innovative medical technologies to patients and clinicians worldwide.
Ultimately, a well-executed global registration and approval process not only opens doors to new markets but also reinforces a company’s reputation as a trusted and reliable partner in the healthcare ecosystem.