Registration Services - BIO23 MedTech

Define the optimal filing pathway based on product characteristics and target-market regulations, with risk classification and launch strategy.

Regulatory landscape review

Risk classification

Pathway decision-making

Timeline & cost estimation

Prepare technical dossiers per target authority requirements, converting language, format and evidence chains into compliant submissions.

Technical Documentation Authoring

Multilingual Translation & Localization

Regulatory Format Compliance Review

Evidence Compilation & Traceability

Serve as the local authorized representative (AR / Sponsor / UKRP) for foreign manufacturers, handling regulatory liaison and filing.

Authorized Representative Services

Regulatory liaison

EUDAMED &PPWR Registration

Ongoing Compliance Support

Submit formal filings and follow the full review process, responding to deficiencies and tracking certification.

Formal submission

Review tracking

Deficiency response

Certification coordination

Maintain registration certificates, file product change notifications and manage ongoing post-market compliance.

Certificate renewal

Change notification

Annual update/Renewal management

Post-market compliance

Coordinate filings across multiple markets, reusing technical evidence to unify timing and delivery.

Multi-market roadmap

Evidence reuse

Timing coordination

Unified delivery

Standardized Global Registration Process

Submit a consultation request and our experts will provide an initial assessment and quote within 24 hours.