Officers and regulatory representatives of BioDomi
ZHANG LuYue
The Deputy PRRC supports the Primary PRRC and ensures continuity of regulatory oversight. Responsibilities:
1. Assist in reviewing manufacturer regulatory documents.
2.Support implementation and monitoring of post-market surveillance.
3.Participate in vigilance case assessment and document review.
4.Support regulatory communication and document management.
5.Maintain regulatory records for Authorized Representative activities.
6.Manage EUDAMED registration and compliance.
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CAO Aidi
The Primary PRRC holds the main responsibility for regulatory compliance oversight within the
Authorized Representative organization.
1. Regulatory Oversight
2. Manufacturer Documentation Verification
3. Regulatory Communication
4. Post-Market Surveillance Oversight
5. Vigilance Oversight
6. Regulatory Record Management
7. Declaration for Devices for Investigational Use