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

Registration Process:       

• 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:    

ISO 13485

Registration Timeline:      

Class I – 1 month

Others – 6 – 12 months

License Validity:     

5 years