Medical Device Registration in
Bolivia
Ministry of Health:
Ministerio de Salud y Deportes
Regulatory Authority:
La Agencia Estatal de Medicamentos y Tecnologias en Salud (AGEMED)
Medical Device Regulation:
Bolivian Medicines Law
Bolivian Heath Registration Manual
Official Language:
Spanish
Classification:
Class I, IIa, IIb and III
Medical Device Registration in Bolivia:
- 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.
Documents Required:
- Ministerial or Secretarial Resolution
- Company certificate
- License and Manufacturer information
- QMS certificate
- FSC
- Any previous sanitary registrations
- Legal Representation
- Technical File
- Labels, IFUs, Manual
- Sample
- Payment Receipt of Sanitary Registry Evaluation
Legalized/Notarised Documents (if any)
Free Sales Certificate
Applicable QMS:
Registration Timeline:
Class I – 1 month
Others – 6 – 12 months
License Validity:
5 years