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類別: REGULATORY PATHWAYS
授權代表
在監管管轄區設立的代表外國製造商進行監管事務的法律實體。根據EU MDR，非歐盟製造商必須指定歐盟授權代表（EC REP）。在日本，此角色由DMAL持有人承擔。
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
Expanded process notes below are currently maintained in English; the short definition above is localized. See our editorial policy.
WHEN IT APPLIES
Foreign manufacturers without a legal presence in a market often must appoint a local authorized representative (or equivalent role) to handle registrations, communications, and post-market duties. Under EU MDR this is the EU Authorized Representative (EC REP) for non-EU manufacturers.
PROCESS / STEPS
- Confirm whether local establishment is mandatory in the target market (EU, UK, China MAH, Japan DMAL, etc.).
- Define contractual responsibilities: registrations, vigilance, competent authority contact, sample availability.
- Ensure the representative is qualified and appears correctly on labels / IFU / EUDAMED actor registration.
- Align QMS interfaces so complaints and FSCAs flow to the representative within statutory timelines.
- Reassess if manufacturing sites, legal manufacturer identity, or markets change.
EXAMPLES
- EU MDR: non-EU manufacturer designates an EC REP established in the Union.
- China: foreign sponsors typically work through a Chinese Marketing Authorization Holder (MAH), a related but stricter local-responsibility model.
- Japan: foreign manufacturers work through a Designated Marketing Authorization Holder (DMAL).
COMMON MISTAKES
- Appointing a “mailbox” entity that cannot fulfill vigilance or technical documentation duties.
- Labeling that lists the wrong legal manufacturer vs representative roles.
RELATED GUIDES & TOOLS
SOURCES
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