How do life sciences companies enter international markets with regulatory confidence?
We develop and manage international approval strategies for pharma, biotech, MedTech and IVD: the USA (FDA 510(k), De Novo, PMA), Japan (PMDA), China (NMPA), Brazil (ANVISA), the GCC states, the UK and Switzerland, whether in parallel with EU approval or as standalone market entry. The real difficulty is rarely the individual authority but the sequence: many markets require a reference approval in the country of origin, and companies that prioritize target markets by feasibility rather than market potential alone avoid the parallel submissions that grind internal RA teams to a halt.
- Pharma
- Biotech
- MedTech
- IVD
Overview
What challenges arise with international market access?
Approval projects across four continents · FDA 510(k)/De Novo/PMA, PMDA, NMPA, ANVISA, UKCA, Swissmedic
Last updated: 2026-06-12
International approvals are resource-intensive because each target market brings its own regulatory logic. The four points where programs most often get stuck:
- Every market reviews differently: the CE marking under EU 2017/745 (MDR) or EU 2017/746 (IVDR) serves as a reference in third-country markets but is nowhere recognized automatically. Depending on risk class, the USA requires a 510(k) under 21 CFR Part 807, a De Novo under 21 CFR Part 860 or a PMA under 21 CFR Part 814, each with its own classification and evidence logic.
- Local representation requirements delay market launch when set up too late: a US Agent for foreign manufacturers under 21 CFR Part 807, an authorised representative under MDR Art. 11, a UK Responsible Person and a CH-REP under MepV (SR 812.213).
- Approval dossiers must be adapted market by market: pharma dossiers in CTD/eCTD format under ICH M4, technical documentation for medical devices into each country's required format, often with translations and local testing requirements.
- Parallel approvals overload internal RA teams: authority queries from several markets arrive at the same time, and some markets additionally require a reference approval in the country of origin, for example via a Certificate of Free Sale or a CPP under the WHO scheme.
Services
How we support you
Market Approval Strategy & Prioritization
Analysis of the regulatory requirements for each target market and a prioritization matrix by market potential, feasibility and timeline, documented in an international regulatory roadmap with a budget and resource plan.
FDA Approvals: 510(k), De Novo & PMA
Preparation and submission of 510(k) applications under 21 CFR Part 807, De Novo requests under 21 CFR Part 860 and PMA dossiers under 21 CFR Part 814, including a Pre-Submission package (Q-Sub) and support during FDA inspections against the QMSR (21 CFR Part 820).
Learn more →Approvals for APAC, LATAM & the Middle East
Registration dossiers for the PMDA (Japan), NMPA (China), ANVISA (Brazil) and the GCC authorities, coordination of local regulatory affairs partners, and management of translations, adaptations and local testing requirements.
Third-Country Compliance for the UK & Switzerland
UKCA strategy under the UK Medical Devices Regulations 2002 (SI 2002/618), including a UK Responsible Person, plus Swissmedic registration and CH-REP setup under MepV (SR 812.213).
Authority Interaction & Local Representation
Preparation and conduct of authority meetings, such as an FDA Pre-Submission, with briefing documents and a list of questions; identification and contracting of suitable local representatives (US Agent, UK Responsible Person, CH-REP).
Learn more →Registration Lifecycle & Change Management
Maintenance of all active registrations: change notifications, renewals and a change control procedure that assesses every product or labelling change against all target markets before it is implemented.
Learn more →How we work together
What it comes down to
International market access rarely fails because of a single authority, but because of the assumption that EU approval can simply be exported. Each market reviews according to its own logic: the FDA requires, depending on risk class, Substantial Equivalence in a 510(k) under 21 CFR Part 807 or dedicated evidence in a PMA under 21 CFR Part 814, while Japan, China and Brazil demand their own dossier formats, translations and, in part, local testing. On top of this comes a chain of dependencies that dictates the sequence: many markets in LATAM and the GCC region require a reference approval in the country of origin, evidenced by a Certificate of Free Sale or CPP. Companies that ignore this chain and launch all applications in parallel generate authority queries from five procedures at once and overload the very RA team that has to meet the response deadlines.
That is why our work begins not with the first application but with prioritization: which markets are reachable without preconditions, where can existing documentation be reused in eCTD format under ICH M4 or as adapted technical documentation, and which representation obligations (US Agent, UK Responsible Person, CH-REP) need lead time. This shifts the effort to the start of the program, where a corrected sequence saves months, rather than to the submission phase, where every correction blocks an ongoing procedure.
Our approach
Our approach
Step
Result
Market Analysis
Overview of the regulatory requirements, representation obligations and reference-approval prerequisites for each target market.
Approval Strategy & Prioritization
Prioritized roadmap with the sequence of markets, dependencies (e.g. Certificate of Free Sale) and budget framework.
Dossier Adaptation
Market-specific submission dossiers built on the existing EU documentation, in each market's required format (e.g. eCTD under ICH M4, 510(k) structure).
Local Representation & Partners
A designated US Agent, UK Responsible Person or CH-REP and contracted local regulatory partners with clearly assigned roles.
Submission & Authority Interaction
Filed applications and authority queries answered on time, coordinated across all ongoing procedures.
Approval & Maintenance
Granted registrations and ongoing lifecycle management for changes and renewals across all markets.
Common pitfalls
Where projects commonly fail
The EU dossier is reused unchanged.
A 510(k) requires proof of Substantial Equivalence to a predicate device under 21 CFR Part 807, not a clinical evaluation following MDR logic; submitting the technical documentation one-to-one invites Refuse-to-Accept decisions and Additional Information Requests.
Local representation is set up too late.
Without a designated US Agent there is no Establishment Registration under 21 CFR Part 807, and without a CH-REP there is no placing on the market in Switzerland; contract negotiations with local representatives need lead time and otherwise block the planned market launch.
All target markets are launched in parallel.
Authority queries from several procedures arrive at the same time, the RA team cannot keep up with the response deadlines, and procedures stall; prioritizing by feasibility spreads the load over time.
The dependency on reference approvals is overlooked.
Many markets in LATAM and the GCC region require proof of an existing approval in the country of origin, for example via a Certificate of Free Sale or CPP; companies that do not plan for this sequence simply cannot yet submit there.
The UK and Switzerland are treated as quasi-EU.
Since the lapse of the MRA for medical devices, Switzerland is a third country and requires a CH-REP and Swissmedic registration under MepV (SR 812.213); in the UK, the CE marking applies only within time-limited transitional arrangements, after which the UKCA requirement under the UK Medical Devices Regulations 2002 takes effect.
FAQ
Frequently asked questions
Sources
- Regulation (EU) 2017/745 (MDR), Art. 11; Regulation (EU) 2017/746 (IVDR)
- 21 CFR Part 807, 814, 860, 820 (FDA: registration & 510(k), PMA, De Novo, QMSR)
- UK Medical Devices Regulations 2002 (SI 2002/618)
- Medical Devices Ordinance MepV (SR 812.213, Switzerland)
- ICH M4 (Common Technical Document, eCTD)
- Writer source file: entourage-website-writer/output/expertise-pages/regulatory-compliance/internationaler-marktzugang/internationaler-marktzugang.md
- https://theentourage.de/expertise/internationaler-marktzugang/ (existing page content, revised)
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Case Studies
What this looks like in practice
Related insights
All insights →Regulations & standards considered
- EU 2017/745 (MDR)
- MDR Art. 11 (authorised representative)
- EU 2017/746 (IVDR)
- 21 CFR Part 807 (Establishment Registration, US Agent & 510(k))
- 21 CFR Part 814 (Premarket Approval, PMA)
- 21 CFR Part 860 (De Novo classification)
- 21 CFR Part 820 (Quality Management System Regulation, QMSR)
- ISO 13485:2016 (QM system)
- UK Medical Devices Regulations 2002 (SI 2002/618)
- MepV SR 812.213 (Swiss Medical Devices Ordinance)
- ICH M4 (CTD/eCTD)
Related topics
FDA Approval for Medical Devices →
510(k), De Novo and PMA under 21 CFR Part 807, 860 and 814 in detail
Health Authority Interaction →
Authority meetings and scientific advice across all markets
MDR Consulting →
EU approval under EU 2017/745 as the reference base for third-country markets
Regulatory Affairs →
Overall regulatory strategy beyond market access
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