Regulatory strategy and planning for accessing non-EU markets

Access to international markets is not simply a registration process, but a strategic decision that affects timing, cost, regulatory sustainability, and return on investment. Each country has different regulatory requirements, timelines, local representation models and levels of complexity.

FTR Advisor supports manufacturers in defining a non-EU market access strategy.

Request a preliminary market access assessment

Why is a "Market Access Decision" necessary?

Addressing international expansion can generate:

• Regulatory delays
• Unexpected costs
• Documentary duplication
• Unplanned post-market obligations
• Risk of local noncompliance

Our methodological approach?

1. Preliminary device analysis.

We assess:

• Class and type of device
• Certification status (MDR / IVDR)
• Available technical documentation
• Existing clinical evidence

2. Comparative analysis of target markets

For each country we analyze:

• Regulatory model (EC equivalence, local dossier, independent approval)
• Need for local representative
• Average approval times
• Post-market obligations
• Language and labeling requirements
• Any audits or inspections

3. Cost / time / complexity assessment

We support in estimating:

• Registration costs
• Local representation costs
• Documentary adjustments required
• Realistic timelines
• Organizational impact

4. Defining the access roadmap

We build a roadmap that defines:

• Priorities, timing and sequencing
• Resource planning.

The goal is to optimize investment and timing of access.

Countries and areas of focus

We support regulatory access in several geographic areas, including:

• United Kingdom (UKCA)
• Switzerland
• United States (FDA 510(k) / De Novo, if applicable)
• Brazil (ANVISA)
• India
• United Arab Emirates (MOHAP)
• Saudi Arabia
• Other countries upon request

We operate in cooperation with qualified local partners when required by the regulatory framework.