We identify common requirements, strategically reuse existing documentation, and supplement it with market-specific evidence—to ensure a consistent strategy rather than parallel documentation landscapes.
Metecon develops your international regulatory strategy across various target markets: We assess which requirements overlap with the EU framework, for example, how existing documentation and data can be reused in a targeted manner, and where market-specific additional work actually arises.
In this way, we preserve existing work, avoid unnecessary effort, and keep approvals manageable even through product changes—in line with market needs and within realistic resource constraints.
Intended for: Head of Regulatory Affairs / Regulatory Affairs Manager, as well as executive management and C-level executives (CEO, CSO) involved in expansion and market access decisions.
“International approval rarely fails due to regulatory requirements, but rather due to a lack of a plan: Which markets should be targeted and in which order, and what can be reused from the existing documentation? We develop a global market strategy that makes efficient use of your existing documentation and assist you in creating a central regulatory file (core file)—tailored to the market, realistic in terms of resources, and reusable across regulatory changes. This prevents the creation of a fragmented document landscape and instead establishes a consistent, manageable path to multiple markets."
– Signe Neumann Gaspar · Expert in Regulatory Affairs & Technical Documentation · Metecon GmbH
Interdependencies between markets, QMS requirements, and resources are underestimated—resulting in an unrealistic timeline.
Existing documentation is used as-is—market requirements and regulatory specifics are not taken into account.
What must be reported in a given market and the timeframe within which changes may be implemented in the target country—without a clear strategy, this leads to significant coordination efforts, inconsistencies, and, in the worst case, regulatory risk.
Many requirements in international markets are similar. By leveraging these overlaps, you can preserve existing work—and avoid a parallel, difficult-to-manage document landscape.
Three building blocks of a consistent global market strategy.
A gap analysis identifies which data can be reused directly and where market-specific additional work is required.
Systematically identify overlaps and discrepancies.
Reuse documentation, data, and tests in a targeted manner instead of recreating them.
Only invest additional effort where the target market truly requires it.
We work with you to determine a market strategy with market priorities and potential submission pathways—from the EU to the U.S. and other high-growth markets.
510(k), De Novo, or PMA: Determine the appropriate pathway and the required documentation.
Take a structured approach to China (NMPA), Brazil (ANVISA), and other markets.
Prioritize based on need, effort, and dependencies—with a realistic timeline.
Product changes have different effects in different markets—we make it manageable.
Assess a change centrally and break it down across all affected markets.
Deploy EU-REP/EC-REP and CH-REP in a manner appropriate to the market.
A global market strategy considers markets in context: It leverages overlaps and synergies, plans the sequence and resources for market launches, and ensures consistency in changes and change notifications—rather than creating parallel document landscapes and regulatory risks.
Identify strategically relevant markets, determine their order of priority and interdependencies—with a realistic timeline.
The strategy’s lever: Analyze overlaps with the EU framework or the country of origin and make targeted use of existing documentation, evidence, and data—incurring market-specific additional effort only where absolutely necessary.
Make a centralized file structure modular and adaptable, and supplement it to meet market requirements. Standardize key information such as intended purpose, claims” and technical specifications. Ensure consistent use throughout the entire file.
Assess QMS capability for the global market strategy; clarify representation models.
Prepare and support country-specific submissions: FDA/U.S., NMPA/China, ANVISA/Brazil, PMDA/Japan, Health Canada/Canada, TGA/Australia, MFDS/South Korea, CDSCO/India, SFDA/Saudi Arabia, MHRA/United Kingdom, and others.
Evaluate changes across all markets, report them in a timely manner, and keep approvals up to date. Monitor the target market for product-related changes.
Leveraging existing documentation is key: It reduces effort and risk—and that makes market entry more efficient, faster, and more predictable.
Plan the sequence, effort, and dependencies realistically, and don't improvise on a market-by-market basis.
Gap analysis: country of origin ↔ target market – Retain existing documentation, fill in gaps, and avoid extra work.
United States: 510(k) / De Novo / PMA; Japan: Todokede/Ninsho/Shonin; Brazil: "notificação" or "registro" through ANVISA; Canada: Health Canada; Australia: ARTG or conformity assessment via TGA; South Korea: Notification or certification by MDITAC / approval process by MFDS; India: SUGAM; Saudi Arabia: TFA via SFDA GHAD, etc. – clarified as appropriate for the product.
Assess the impact of the change by market—reporting requirements are consistently met.
QMS capability for a global market strategy and appropriate authorised representative/legal manufacturer models.
Part of the Metecon Group: 25+ years of regulatory experience, 50+ compliance experts, and offices in Mannheim and Bern—we translate complex regulations into actionable strategies.
Our benchmarks are based on the strengths of leading providers: global market knowledge, experience with submissions, and the coordination of multiple target markets. Metecon meets these criteria and combines them with the targeted use of existing documentation and integration with the evidence framework for medical device software.
From software verification (MDSW) to classification and international approval: We work together to map out the customer journey—with consistent documentation and clearly defined responsibilities.
Which markets should be entered, and in which order? – including effort, dependencies, and timeline.
Identification of usable evidence and highlight market-specific additional efforts.
Preparing the file in a modular format and supplementing it to suit each market. Technical Documentation →
Preparation and support of submissions to the FDA, NMPA, ANVISA, PMDA, Health Canada, TGA, MFDS, CDSCO, SFDA, MHRA, and others.
Evaluatuation of product changes across markets and reporting them as needed.
Market-appropriate models for authorised representatives and manufacturers. Representative Services→
Clarification of classification and the approval pathway even before submission. This minimizes approval risks and makes the effort involved predictable.
The same global market strategy applies to in-vitro diagnostic medical devices under the IVDR, including country-specific considerations.
Those who identify target markets early in the development phase create documentation and supporting evidence that can be used across different markets—and achieve initial market access at a reasonable cost.
Logical structure for use in various markets.
Technical Documentation→
Ensure QMS compliance for global markets (including MDSAP, QMSR, B-GMP).
QMS & Auditing→
Evaluate market insights consistently across international markets.
Post-Market Surveillance→
Structured data management for global transparency and change management. Digitalization→
EU-REP/EC-REP, CH-REP, and manufacturer models by market.
Representative Services→
Signe Neumann Gaspar is a member of the Regulatory Affairs & Technical Documentation team and brings years of experience in quality management and international regulatory approval. Key areas of focus for the RA/TechDoc team in the field of international regulatory approval: regulatory strategy, market prioritization, gap analyses between source and target markets, classification, market-specific preparation of technical documentation, support for international submissions, change management, and Representative Services (EU-REP/EC-REP and CH-REP). A regulatory strategy and a market access strategy that takes documentation and market priorities into account from the very beginning is crucial for successful international regulatory approval.
As early as possible—ideally, already during the development phase. If you identify target markets early on, you can create structures, documentation, and supporting evidence that can be reused across markets. This saves extra work and speeds up market entry.
Through a consistent global market strategy: Changes are evaluated centrally and rolled out to all affected markets. This makes it clear where a notification or resubmission is necessary—reducing inconsistencies and the effort required for coordination.
This is often the case, as many market requirements are similar to the EU framework. A gap analysis shows which documents can be used directly and where market-specific additional work is required. In this way, the technical documentation becomes the standard the basis rather than the exception.
Based on demand, effort, and dependencies: Where is the demand greatest? Where can initial market access be achieved quickly with a reasonable amount of effort? And which QMS and resource requirements arise? This forms the basis for a regulatory strategy.
The initial submission clarifies the pathway, classification, and file structure; ongoing maintenance keeps the submitted documents up to date with regard to changes, re-registrations, and post-market surveillance obligations. Both require a consistent global regulatory strategy to ensure that nothing is overlooked.
When making expansion decisions, prior to international filings, and when implementing changes that affect various markets. External support provides market insight, leverages existing documentation, and enables realistic planning of the sequence, effort, and resources required.
A regulatory strategy considers markets in context: It leverages overlaps, plans the sequence and allocation of resources, and enables consistent, timely change notifications. A mere collection of documents results in parallel document landscapes, extra work, and inconsistencies.
The product classification determines the approval pathway for each market and, consequently, the effort involved, the documentation required, and the sequence of steps. By considering classification and the approval strategy together, you can minimize approval risks.
The effort involved depends on target markets, product portfolio, the maturity of the documentation, and market prioritization. During a free initial consultation, we will assess your situation, prioritize markets to develop a sound regulatory strategy, and then provide a reliable cost estimate.
Start with a free initial consultation—we will prioritize your target markets, leverage existing documentation, and develop a consistent global market strategy for you. We turn complexity into clarity.
Your contact:
Dr. Caroline Arnold
Head of Sales
T: +49 621 123469-037
caroline.arnold@metecon.de
