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Ecuador

Medical Device Registration in Ecuador

Ministry of Health

Ministry of Public Health

Regulatory Authority

National Agency for Sanitary Regulation, Control and Surveillance (ARCSA)

Medical Device Regulation

  • Resolution ARCSA-DE-021-2020-MAFG – Issuance of the operating permit to establishments that manufacture, import, store, distribute, market and transport medical devices
  • IE-B.3.2.1-DM-01 Requirements for registration, re-registration and modification of the health registration of medical devices for human use

Official Language

Spanish

Classification

Class I, II, III and IV

Registration Process

  • Determine the device classification
  • Appoint an authorized representative
  • Prepare the application form and technical documentation
  • The Authorized Representative submits the technical documentation to the ARCSA.
  • Once approved, the medical device can be marketed in Ecuador

Documents Required

  • Letter of Authorization
  • List of medical devices to be registered
  • Certificate of Free Sales
  • QMS or GMP certificate
  • Product Description
  • Technical documents
  • Labels, IFUs, or User manual
  • Stability reports

Legalized/Notarised Documents (if any)

Free Sales Certificate

Applicable QMS

GMP or ISO 13485

Registration Timeline

2-6 months

Authorized Representative

Yes

License Validity

5 years

Special Notes

  • The certification renewal process must be initiated 90 days before the expiration.
  • Documents and Labelling must be in Spanish

Want to know more about this registration process?