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

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

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