Pharma
- What applies
- The marketing authorisation dossier follows the CTD/eCTD format under ICH M4.
How do life sciences companies achieve international market access with regulatory confidence?
We manage international market access for pharma, biotech, MedTech and IVD: USA (FDA), Japan (PMDA), China (NMPA), Brazil (ANVISA), GCC states, UK and Switzerland. Many markets require a reference approval in the home market: prioritizing target markets by feasibility rather than potential avoids parallel filings that paralyze RA teams.
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: September 18, 2026
International approvals are resource-intensive because each target market brings its own regulatory logic.
- 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.
Industries
What this means in your industry
Biotech
- What applies
- As in pharma: dossier in CTD/eCTD format under ICH M4.
MedTech
- What applies
- EU under the MDR with an authorised representative (Art. 11), US via 510(k), De Novo or PMA, UK under SI 2002/618, Switzerland under MepV.
- Who audits
- Class IIa to III: the notified body. Class I: it is not or barely involved.
IVD
- What applies
- As for medical devices, only under the IVDR; in Switzerland the IvDV applies.
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.
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.
How we work together
What it comes down to
EU approval carries no weight in any other market.
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 these market-specific dossier requirements 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 market-entry dependency 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.
Because launching all applications in parallel overloads the RA team with simultaneous authority queries, 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.
At the start of the program a corrected order saves months; in the submission phase every correction blocks an ongoing procedure.
One market currently carries a deadline that is missing from many roadmaps: Switzerland. Device registration in swissdamed, the Swissmedic database with its Actors and UDI Devices modules, has been mandatory since 1 July 2026. It replaces the previous notification, and the transitional period ends on 31 December 2026.
The point that is easy to miss: swissdamed and EUDAMED are separate. A company that registered in EUDAMED in May 2026 has done nothing for Switzerland. The effort rarely sits in the data entry but in the reconciliation before it, namely which product variants are actually shipped to Switzerland and who supplies the UDI data to the Swiss authorised representative.
In the market access projects Entourage runs, this reconciliation between shipped product variants and the Swiss authorised representative is where timelines slip, not the authority submission itself.
| Market | Local representation | Legal basis |
|---|---|---|
| EU | Authorised representative | MDR Art. 11 |
| USA | US Agent (for foreign manufacturers) | 21 CFR Part 807 |
| UK | UK Responsible Person | |
| Switzerland | CH-REP | MepV |
Our approach
Our approach
Step
Result
01
Market Analysis
Overview of the regulatory requirements, representation obligations and reference-approval prerequisites for each target market.
02
Approval Strategy & Prioritization
Prioritized roadmap with the sequence of markets, dependencies (e.g. Certificate of Free Sale) and budget framework.
03
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).
04
Local Representation & Partners
A designated US Agent, UK Responsible Person or CH-REP and contracted local regulatory partners with clearly assigned roles.
05
Submission & Authority Interaction
Filed applications and authority queries answered on time, coordinated across all ongoing procedures.
06
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 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.
The EUDAMED registration is counted toward Switzerland.
swissdamed and EUDAMED are separate databases, and an entry in one creates nothing in the other. Device registration in swissdamed has been mandatory since 1 July 2026 and replaces the previous notification; the transitional period ends on 31 December 2026.
Regulatory Affairs
Do any of these pitfalls apply to you?
In a first call we assess your situation and say what needs clarifying first in your case. Without obligation, reply usually within one working day.
FAQ
Frequently asked questions
The 510(k) under 21 CFR Part 807 is a premarket notification procedure that demonstrates Substantial Equivalence to an already cleared predicate device. The CE marking under EU 2017/745 (MDR) requires a full clinical evaluation and, from Class IIa onward, the involvement of a notified body. Both pathways require technical documentation, but in different formats and to different content standards.
Most markets require a local representative or importer who assumes regulatory responsibility: in the EU the authorised representative under MDR Art. 11, in the USA the US Agent for foreign manufacturers under 21 CFR Part 807, in the UK the UK Responsible Person and in Switzerland the CH-REP under MepV. We support the identification and contracting of suitable partners.
As benchmarks: a 510(k) typically 3 to 12 months, a De Novo 9 to 18 months, a PMA 1 to 3 years. The actual duration depends on the completeness of the application, the product type and the FDA's workload; a Pre-Submission meeting significantly reduces the risk of additional-information rounds.
Only within time-limited transitional arrangements, whose deadlines run differently depending on the product category and the underlying EU regulation. On a permanent basis, the UK market requires the UKCA marking under the UK Medical Devices Regulations 2002 (SI 2002/618) and a UK Responsible Person. We develop the UK strategy, including transition planning.
Switzerland has treated EU manufacturers of medical devices as third-country manufacturers since the lapse of the Mutual Recognition Agreement. Required are a Swiss authorised representative (CH-REP), registration in swissdamed and compliance with MepV (SR 812.213). Device registration has been mandatory since 1 July 2026 and runs through the UDI Devices module; it replaces the previous notification, and the transitional period ends on 31 December 2026. The CE marking remains the technical basis but does not replace these obligations.
By feasibility, not by market potential alone. Three factors are decisive: which markets require a reference approval in the country of origin (Certificate of Free Sale, CPP), how much existing documentation can be reused for each market (e.g. eCTD under ICH M4), and which response deadlines the internal RA team can carry in parallel.
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) and Ordinance on In Vitro Diagnostic Medical Devices (IvDV)
- Swissmedic, swissdamed: mandatory registration for medical devices and in vitro diagnostic medical devices from 1 July 2026, transitional period until 31 December 2026: https://www.swissmedic.ch/swissmedic/en/home/news/mitteilungen/swissdamed-registrierungspflicht.html
- ICH M4 (Common Technical Document, eCTD)
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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)
- IvDV (Swiss Ordinance on In Vitro Diagnostic Medical Devices)
- swissdamed (Swissmedic database, Actors and UDI Devices modules)
- ICH M4 (CTD/eCTD)
Related topics
FDA Clearance & Approval →
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 Conformity →
EU approval under EU 2017/745 as the reference base for third-country markets
Regulatory Affairs →
Overall regulatory strategy beyond market access
UKCA Marking & Great Britain Access →
Great Britain in detail: UKCA, UK Responsible Person, MHRA registration and Part 4A
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