Global market registrations

MedQAIR supports regulatory registration and submission activities for the European Union, United States, Canada, and other international markets. This includes MDR, IVDR, FDA, Health Canada, and multi-market regulatory alignment activities.

Yes. We support software medical devices (SaMD), AI-enabled systems, medical devices, and IVDs across different regulatory frameworks and market registration pathways.

Global pathway planning involves assessing device classification, intended use, applicable regulations, submission routes, evidence requirements, quality system expectations, and market-specific obligations before starting registration activities.

Yes. Different jurisdictions often require overlapping but non-identical documentation. We help manufacturers align technical files, clinical evidence, cybersecurity documentation, and quality system materials across multiple regulatory frameworks to reduce duplication and inconsistencies.

To enter the Canadian market MDSAP implementation is required, we can support in upgrading the Quality Management System to align with MDSAP.

Yes. MedQAIR supports regulatory submissions for the US (FDA), Canada (Health Canada), and other global markets. This includes preparing 510(k), De Novo, PMA, and Canadian licensing documentation, as well as aligning technical files for multi-market compliance.

The appropriate FDA submission pathway depends on factors such as the intended purpose, indications for use, risk profile, technological characteristics, and whether a suitable predicate device exists. Depending on these factors, manufacturers may pursue a 510(k), De Novo, PMA, or other FDA pathway. Early pathway assessment helps reduce submission delays and unexpected regulatory challenges.

A 513(g) request allows manufacturers to obtain FDA feedback regarding the likely regulatory classification and applicable submission pathway for a product. It can be particularly useful when classification is unclear, when novel technologies are involved, or when organisations are assessing regulatory strategies before investing in submission preparation activities.

The Medical Device Single Audit Program (MDSAP) allows manufacturers to undergo a single quality management system audit that can be accepted by multiple participating regulatory authorities. MDSAP is particularly important for access to the Canadian market and may also support regulatory activities in other participating jurisdictions.

Device classification influences regulatory requirements, evidence expectations, submission pathways, conformity assessment activities, and post-market obligations. Because classification approaches differ between jurisdictions, manufacturers should assess classification requirements early when planning registrations across multiple markets.

Intended purpose and indications for use are fundamental to determining how a product is regulated. They influence classification, applicable regulations, clinical evidence expectations, risk assessments, and market authorisation pathways. Small changes in product claims can sometimes have significant regulatory consequences.

Unique Device Identification (UDI) requirements help regulators, healthcare organisations, and manufacturers identify products throughout their lifecycle. Different jurisdictions maintain their own registration systems and databases, including EUDAMED in Europe, GUDID in the United States, and SwissDAMED in Switzerland. Registration planning should consider these obligations early in the market entry process.

A submission readiness review evaluates whether the technical documentation, quality system records, clinical evidence, cybersecurity documentation, labelling, and supporting materials are sufficiently complete for submission. These reviews help identify gaps before formal regulatory interactions occur, reducing the likelihood of delays or additional information requests.

Many jurisdictions require similar information but organise and assess it differently. Effective multi-market planning focuses on creating documentation that can be leveraged across multiple regulatory frameworks while addressing market-specific requirements. This approach can reduce duplication, improve consistency, and support more efficient registration activities.

MedQAIR supports manufacturers with regulatory pathway planning, device classification, intended purpose assessments, FDA submission preparation, MDR and IVDR conformity activities, MDSAP implementation, UDI strategies, registration database support, and multi-market submission coordination. Our goal is to help organisations navigate international registration requirements while maintaining consistency across their regulatory documentation and compliance activities.