Regulatory Affairs Support
Guidance on import regulations and distributor compliance documentation.
Service overview
Regulatory affairs support
Our Regulatory Affairs Support service helps you import with confidence. We verify that every manufacturer holds current CE marking and ISO 13485 certification and collect the technical documentation you need to support product registration in your market.
We provide general guidance on common documentation requirements and confirm HS codes for customs. For country-specific regulatory advice, we signpost you to local regulatory specialists or medical-device importers, as registration is managed by you as the local distributor.
We do not make medical or therapeutic claims; all product descriptions reflect technical specifications only. Our role is to ensure products are sourced from CE / ISO 13485 certified manufacturers and to supply the documentation that supports your registration and import process.
Capabilities & Features
Service category
Category
Details
Certification Checks
CE marking status verification
ISO 13485 certificate currency checks
Manufacturer technical file review
Declaration of conformity confirmation
Certification document collection
Import Guidance
Common import-documentation guidance
HS code confirmation for customs
Country-requirement signposting
Referral to local regulatory specialists
Import-permit guidance
Registration Support
Manufacturer certificates for registration
Technical files and documentation
Product specification sheets
Support for distributor applications
Documentation tailored to your market
Simple & Transparent
Our proven workflow
Step 1
Enquiry and sourcing
Step 2
Quality verification
Step 3
Documentation and dispatch
Common questions
Frequently asked questions
Get in touch
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