Medical Device Registration in
Ecuador
Ministry of 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
Medical Device Registration in Ecuador
- 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