Through Executive Decree No. 5 of January 24, 2022, MOH authorizes the self-applied tests to detect COVID-19, and confirms that the competent entity for their registration will be the Gorgas Memorial Institute, in order to respond expeditiously the growing demand for tests.
• Any person (public or private, natural or legal) that imports and sells self-administered tests must have a permit endorsed by Gorgas.
• 1 product per file will be accepted.
Requirements:
1. Power of attorney notarized and signed by the legal representative of the distribution company and the lawyer.
2. Copy of the current Operating License issued by the National Directorate of Medical Devices of the MOH.
3. Sworn Declaration signed by the Legal Representative of the distributor.
4. Copy of the Operation Notice, which includes the activity described in the Operation License.
5. Certificate of Public Registry
6. Authorization letter from the manufacturer, notarized and Apostilled (original and copy). Translated into Spanish if applicable.
7. Certificate of Free Sale Apostilled or notarized from the country of origin (original and copy, translated into Spanish), and in the case of products from regions other than the United States, provide a Certificate of Free Sale that includes the CE marking or the certification of the latter.
**If CFS is not available, it is possible to submit the FDA Emergency Use Authorization (EUA) that identifies the device to be registered, duly legalized and translated.
8. Certificate of Good Manufacturing Practices issued by the competent authority of the country of origin (actual manufacturer) or, ISO 13485:16 certification, notarized or apostilled. Original and copy accompanied by its translation.
9. Marketing history of the trial to be recorded.
10. Form 1 signed by the legal representative of the company or the person designated by him.
11. Insert of the test to be registered in Spanish, which must contain the sensitivity and specificity of the product, in a value equal to or greater than 90%.
12. Packaging label as it will be marketed in the country, which must contain at least the information of the trade name, catalog, brand, manufacturer, country, distributor and health registration.
Duration of the Registry: it will be in force until the health authority considers that the extraordinary public health measure should remain.
For more information, contact: info@central-law.com
Yolianna Arosemena Benedetti
