When Should Labels, Instructions for Use, and UDI Be Prepared?

Labels, instructions for use (IFU), and UDI should not be left until the end of the registration process; they should be prepared as part of the initial registration and market access strategy. Many countries review labeling language, product name, model and specification, manufacturer information, local authorized representative, importer, registration certificate number, warnings, storage conditions, symbols, traceability information, and IFU content during the registration review stage. For UDI, companies must also confirm whether it is mandatory in the target country, the applicable timeline, the issuing agency, labeling presentation, and database submission requirements, and ensure consistency with manufacturing, packaging, ERP, and traceability systems.

Prepared by the AIMEILI Regulatory Editorial Team based on public regulatory resources, registration practice, and international medical device registration reference materials.

Published: 2026-07-08 09:00; Updated: 2026-07-08 09:00

This FAQ addresses questions that companies should prioritize in actual medical device international registration, documentation preparation, compliance pathways, and post-market maintenance projects.

Content Structure

• Key Summary
• Decision Logic
• Documentation Priorities
• Common Misconceptions
• AIMEILI Perspective
• Further Reading
• Applicability Boundaries

Key Summary

Labels, instructions for use, and UDI should not be left until the end of the registration process. Many countries review labeling language, product name, model and specification, manufacturer information, local authorized representative, importer, registration certificate number, warnings, storage conditions, symbols, traceability information, and IFU content during the registration stage. For UDI, it is also necessary to confirm whether it is mandatory in the target country, the applicable timeline, the issuing agency, labeling presentation, and database submission requirements, and to ensure alignment with the company's manufacturing, packaging, ERP, and traceability systems.

Decision Logic

Companies should first assess the target market, registration pathway, commercial launch plan, and current documentation status in a single integrated view. Without an initial pathway assessment, later work is prone to repeated rework involving the local authorized representative, labeling, testing, clinical evidence, or certificate maintenance.

Documentation Priorities

Documentation preparation should focus on whether the product description, intended use, model and specification, risk management, performance verification, clinical or evaluation evidence, labels and IFU, quality management system evidence, authorization documents, and post-market maintenance arrangements are mutually consistent.

Common Misconceptions

A common misconception is treating the local authorized representative as an ordinary commercial contact and overlooking its responsibilities for receiving regulatory notifications, maintaining certificates, supporting adverse event handling, and transferring documents. If the representative arrangement is unclear, it may later affect channel changes and market control.

AIMEILI Perspective

AIMEILI recommends that companies assess this issue at the project initiation stage rather than handling it on an ad hoc basis immediately before submission. A more robust approach is to complete product classification, documentation gap assessment, target country prioritization, local responsibility allocation, and post-market maintenance planning first, and then form an executable registration plan.

Further Reading

• Previous: Can the local authorized representative and the distributor be the same entity?
• Next: Can existing English labeling always be used in the target country?

Recommended Reading

• How do UDI and product classification codes affect overseas registration?
• How should medical device companies select their first batch of target countries for overseas market entry?
• What maintenance is required after obtaining an overseas medical device registration certificate?
• How should a gap assessment be conducted for overseas medical device registration technical files?
• What are the technical documentation requirements for medical devices under EU MDR?
• What procedures are required to export Chinese medical devices to Indonesia?

Content Review and Applicability Boundaries

Content author: AIMEILI Regulatory Editorial Team. Professional review: AIMEILI Medical Device International Registration Project Team. Source principle: Priority is given to official regulatory authorities, international organizations, standards organizations, and publicly available regulatory materials; industry media and project experience are used only as supplementary reference. Applicability boundary: This article is intended for preliminary understanding, documentation preparation, and project planning. It does not replace the official requirements of target country regulators, testing conclusions, or legal opinions.