Audit Process and Timelines
Initial Certification
| Step | Indicative Timeline |
|---|---|
| Submit QMS documentation + application | Day 0 |
| NB document review (completeness check) | 4–8 weeks |
| NB technical review (QMS documentation) | 8–16 weeks |
| Technical documentation assessment (Class III) | Add 6–12 months |
| On-site QMS audit | 1–5 days on-site |
| NB questions / deficiency requests | Variable (1–3 rounds) |
| Certificate issuance | Total: 12–24+ months (Class III) |
Surveillance Audits
After initial certification: annual on-site surveillance audits (1–3 days typically). Full reassessment every 5 years. Some NBs offer remote surveillance for limited scope activities with prior Swissmedic-acceptable justification.
Unannounced Audits
At least one unannounced audit per 5-year period per manufacturer. Focus areas: production processes, CAPA implementation, complaint handling, and PMS activities. The manufacturer cannot refuse access.
Design Examination (Class III — Annex IX Chapter II)
Full technical documentation review for each Class III device or device group. Multiple question rounds are common. Timeline depends heavily on NB workload and documentation completeness. First-time design examinations for novel devices: allow 12–18 months.
Official Sources
AI-assisted navigation aid only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.