Medical Device Registration in
Ministry of Health:
Medical Device Regulation:
Bolivian Medicines Law
Bolivian Heath Registration Manual
Class I, IIa, IIb and III
- Payment at the Sanitary Registry Service.
- Required documents must be submitted as per the Device class.
- The decision may be Approved, Observed, or Rejected.
- If approved, the Sanitary Registration certificate will be delivered in 60 working days.
- If Observed, the corrections or additional documents should be provided within 60 working days.
- The holder must notify the start of the marketing in Bolivia.
- Ministerial or Secretarial Resolution
- Company certificate
- License and Manufacturer information
- QMS certificate
- Any previous sanitary registrations
- Legal Representation
- Technical File
- Labels, IFUs, Manual
- Payment Receipt of Sanitary Registry Evaluation
Legalized/Notarised Documents (if any)
Free Sales Certificate
Class I – 1 month
Others – 6 – 12 months