Medical Device Regulatory Requirements in Ecuador

Regulatory Authority National Agency for Health Regulation, Control and Surveillance
Regulatory Authority Website Link Click Here
Device Classification I,II,III,IV
Medical Device Regulations Regulations and Instructions (Same Regulations for IVD) | Click Here
IVD Classification I, II, III, IV
In Vitro Diagnostics Regulations Regulations
Device Classification Guidelines Risk based classification methodology for medical Devices | Click Here
Registration Process National and Foreign Registration of Health Registry | Click Here
Registration Timeline 3 to 6 months
Technical Documentation Format

Technical Documentation:

  1.  Product quality and sterility certificates issued by those responsible. Each certificate must include the original signature, name, and position of the responsible technician.
  2. Finished product specifications.
  3. Description of product use.
  4. Product stability certificate with the signature of the responsible technician who carried out the study.
  5. Interpretation of the batch code, with original signatures, name and position of the responsible technician.
  6. Original product label and provisional label formats for the requested group, in Spanish, user instructions and original catalogs (brochures) from the importing country.
  7. Scientific literature on the product.
| Click Here
Requirement of Authorized Representative Yes
Language Requirement Labels must be in Spanish Language
Labeling Requirements

The labeling project under which the product will be marketed in Ecuador must contain at a minimum:


a. Trade name of the product
b. Contents of the container or packaging
c. Indications for use, when applicable
d. Warnings and precautions for use, which may be represented with symbols
e. Storage conditions according to the stability study of the medical device, which may be represented with symbols
f. Name, city, and country of the manufacturer
g. Manufacturing sites, when applicable
h. Expiration date, when applicable
i. Shelf life, when applicable
j. Storage temperature according to the stability study of the medical device, when applicable; may be represented with symbols


If not applicable, the manufacturer must present the corresponding justification when this is not included in any of the documents required for registration.


k. Batch or serial number
l. Sanitary Registration Number
m. Warnings, which may include images or symbols, as follows:
 i. "Before using this product, see the attached instructions/manual," for those human-use medical devices that require the inclusion of the instruction manual
 ii. "Sterile", for those products that require it
 iii. "Single-use or non-reusable product", for sterile medical devices that are not reusable
 iv. "Protect from light," when applicable

| Click Here
Adverse Event Reporting Timelines

Health establishments or health professionals must notify serious adverse events, whether expected or unexpected, within a maximum of 48 hours of becoming aware of the event. Non-serious adverse events, whether expected or unexpected, must be reported

Contact Phone (+593 4) 3727440
Contact Address Samanes Citadel, Francisco de Orellana Avenue and Paseo del Parque Avenue. Samanes Park Block 5, Guayaquil, Ecuador.
Disclaimer: This website sources information from regulatory authorities and aims for accuracy, but regulations may change without notice. Users are advised to verify details with relevant authorities before making compliance decisions. We are not responsible for errors, omissions, or outdated content.

The above information is last updated on 09/Jul/2025

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