← 所有术语
类别: REGULATORY PATHWAYS
授权代表
在监管管辖区设立的代表外国制造商进行监管事务的法律实体。根据EU MDR，非欧盟制造商必须指定欧盟授权代表（EC REP）。在日本，此角色由DMAL持有人承担。
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
Track regulatory signals related to 授权代表 across 27 authorities in real time.
START FREE →