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Mandatory ISO 13485 Certification: Domestic medical device manufacturers in Ecuador must obtain ISO 13485 certification, which establishes best practices in quality management, by May 2025. This measure is mandatory as of November 2023.
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Importance of Certification: ISO 13485 certification is crucial to ensure that medical devices manufactured in Ecuador meet the highest international quality standards, thus protecting public health.
Consequences of Non-Compliance: Manufacturers that fail to obtain certification will face the disqualification of sanitary registrations and the prohibition of manufacturing and commercialization of their products.
Regulatory Impact
| Impact Type | Status |
|---|---|
| Top Priority | |
| Type Certificate | |
| Spectrum Bands | |
| Import Changes (HS Codes) | |
| Standard Changes | |
| Product Changes | |
| Label Changes |