Clear pathways to European compliance.
Direct answers on European Authorized Representative liabilities, technical file triage protocols, and Singapore HSA registration timelines.
Direct Answers
Our regulatory counsel addresses critical questions regarding representative transition, technical file triage, and border-control clearance.
What are the legal liabilities of an EU Authorized Representative?
How does technical file triage prepare us for sudden audits?
What are your typical registration and review timelines?
Do you provide bilingual support for Chinese manufacturers?
Under MDR and IVDR, an Authorized Representative is jointly and severally liable for defective devices. We actively verify your EU Declaration of Conformity and technical documentation to mitigate compliance risks before border-control clearance.
We perform reviews of your technical files prior to market entry. This proactive triage identifies gaps in clinical evaluations and risk management, ensuring your dossiers are permanently audit-ready.
CE document reviews are completed within 30 business days.
Absolutely. We provide comprehensive English-Chinese advisory services. This bilingual regulatory guidance guarantees effective communication between your production teams and European competent authorities. Please be aware that we do not offer translation services.
Still have unanswered regulatory questions?
Submit your technical query directly to our compliance officers for a preliminary file evaluation.