Dirigeants et représentants réglementaires de 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.
Masqué
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