Non-controlled Class I and lla devices are eligible for "automatic" registration. Controlled devices and Class Mb and III devices are subject to pre-market approval. The device registration process for pre-market approval of Controlled devices and Class lib and III devices will require the following steps: 1. Appoint local representative through power of attorney. 2. Ensure documents provided by the manufacturer are compliant with INVIMA requirements. 3. Compile the technical submission in Spanish (or at least Spanish summaries of test reports). 4. Provide product certifications and manufacturer's testing methodology. 5. File the application with INVIMA. 6. Answer any questions that INVIMA may ask regarding the registration (responses must be submitted within 90 business days of the request). 7. Upon approval, begin marketing. 8. Make any legal and technical revisions of the application, if required by INVIMA. 9. Maintain post-market obligations.
