Global market access
Clarify the pathway
before investing in execution
The same medical device may face different classification, evidence, testing and local-responsibility requirements in each market. Start with a clear market map.
United States
FDA
Determine regulatory status and submission route from intended use and risk before planning evidence, testing and quality-system work.
Clarify first
- Device status and classification
- Exempt, 510(k), De Novo or PMA pathway
- Registration, listing and US Agent arrangements
Typical workstreams
- Standards, performance and biocompatibility evidence
- Submission, labeling and software documentation
- QMSR readiness and inspection support
European Union
MDR / IVDR
Coordinate technical documentation, testing, quality systems and post-market obligations around intended purpose, classification and conformity assessment.
Clarify first
- MDR or IVDR applicability and classification
- Need for notified-body involvement
- EU representative, importer and operator roles
Typical workstreams
- Technical files, risk management and clinical/performance evaluation
- Standards, testing evidence and report gap review
- QMS, UDI, registration and post-market compliance
United Kingdom
MHRA
Review the product, existing certification and current UK arrangements to confirm registration, marking and local-responsibility needs.
Clarify first
- Classification and applicable framework
- How existing CE certification supports the plan
- UK Responsible Person and MHRA registration
Typical workstreams
- UK adaptation of documentation and labeling
- Registration data and change maintenance
- UKCA planning and ongoing compliance
United Arab Emirates
UAE market access
Confirm the applicable federal and local route from the sales territory, device category and existing market approvals.
Clarify first
- Classification and reference-market approvals
- Local authorized representative or applicant
- Applicability of MOHAP and Dubai requirements
Typical workstreams
- Certificates, technical evidence and labeling
- Legalization and local filing coordination
- Maintenance, changes and post-market support
Saudi Arabia
SFDA
Map the documentation base and compliance responsibilities around classification, local representation and market-access requirements.
Clarify first
- Classification, intended purpose and model range
- Existing overseas approvals
- Local representative and applicant arrangements
Typical workstreams
- Technical evidence, labeling and conformity documents
- Application and authority queries
- License maintenance, changes and post-market work
Additional countries and regions
Beyond five markets
We can also help frame market-access requirements for Australia, Brazil, Korea, Indonesia, India, Egypt and Southeast Asia. Regulatory roles, reference markets, local representation and documentation should be confirmed market by market.
Keep the first conversation simple
Start with basic information
- ProductName, intended use, photo or IFU
- MarketTarget country or region
- StatusExisting certificates, reports and QMS
- QuestionCurrent obstacle or customer request
Need a product-specific review?
Tell Serena your product and target market
We will first clarify what needs verification, then involve the appropriate professionals for a document-based assessment.