Regulatory Medical Device Registration in Ecuador
- REGULATORY AUTHORITY: Medical devices are regulated by the ARCSA or Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (National Health Regulation, Control, and Surveillance Agency). Read more (in Spanish).
- CLASSIFICATION SYSTEM: Medical devices are classified according to the EU risk-based model into Classes I, IIa, IIb, III, and IV.
- TIMEFRAME: 30 days for file review and preparation of dossier in Spanish. 15-30 days for ARCSA review and approval.
- AUTHORIZED REPRESENTATIVE: A local authorized representative (AR) is required to register medical devices in Ecuador. Your distributor must be your AR and will be the titleholder of the ARCSA registration certificate.
We can assist with the preparation and submission of your product registration dossier file and application to ARCSA. We will compile your technical and legal file, will review all labeling for compliance, and will provide post-submission assistance with ARCSA all the way through the approval of the device registration.
This offering includes,
Unlimited regulatory and business strategy sessions with you.
Review of your market readiness (i.e., distributor partner program, contract, website, marketing material) and recommendations to successfully enter the market.
Review of technical and legal documentation, gap analysis and classification of your product.
Interaction with your local distributor to gather and review their legal documentation to attach to the dossier file.
Preparation and submission of the final dossier file to ARCSA.
Answering post-submission follow-up questions from the ARCSA reviewer.
*50% payable upon receipt of invoice, and remaining 50% payable upon submission to INVIMA. If your product already has marketing authorization in the US, EU, Canada, Australia or Japan, ARCSA will approve your product faster. For medical devices, pricing does not include cost of implementing or auditing a quality management system compliant with ISO 13485 or US FDA 21 CFR Part 820, if applicable.
ARCSA fees: USD 905. Fees are valid until december 2018 and are approximated due to exchange rate fluctuations.
- Document translations to Spanish. LATAM Market Access Inc. can translate these documents and will invoiced you at USD 0.25 per word in Spanish.
- Foreign documents which must be notarized/apostilled, such as your certificate of free sale/certificate to foreign government and letter of representation.