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Bolivia

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

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

Want to know more about this registration process?