Grupo Profesional SERTERE – Regulatory Consulting in Venezuela
Medical Device Registration
Professional medical device registration in Venezuela. Support with SACS, MPPS, and INHRR compliance, classification, and dossier preparation.
40+ years of experience
Experts in Venezuelan regulatory processes
Complete dossier and labeling support
Medical Device Registration in Venezuela
We support manufacturers and distributors with medical device registration in Venezuela, ensuring compliance with all regulatory and technical requirements.
Regulatory Authorities
- MPPS
- SACS
- INHRR
Regulatory Requirements
- Sanitary Registration Certificate
- Risk classification (Class I–IV)
- Technical dossier submission
- ISO 13485 / GMP certification
- Clinical/performance data
- Spanish labeling and IFU
Local Testing Requirements in Venezuela
- Local testing is not always mandatory, depending on device classification
- International certifications and testing are often accepted if properly documented
Higher-risk devices (Class III and IV) may require:
- Additional performance or safety data
- Possible local evaluation or verification by authorities