New regime for manufacturers and importing companies for medical products and in vitro diagnostics products.
Through the Regulation No. 7425/2013, published in December in the Official Gazette, ANMAT has established that the activities of manufacture and importation of medical products and in vitro diagnostics products could only been done after an “authorization of operations” according to Regulation N ° 2319/02 (TO 2004).
Consequently, they must be in accordance with the provisions of GMC Resolution No. 20/11 (incorporated into national law through ANMAT disposition N ° 3266/13). This agency is empowered to verify the compliance of “good practices” in all establishments.
This regulation also provides that manufacturers or importers of in vitro diagnostic products, which may be registered by the N ° 2676/99 and No. 3623/97, should submit an application for authorization to operate as contemplated in ANMAT disposition N ° 2319/02 (TO 2004) within the period of 90 calendar days counted from December 11, 2013.
Furthermore, manufacturers or importers of medical products that, upon the effective date that this disposition come into force, that were found registered and functioning in terms of ANMAT N ° 2319/02 (TO 2004), shall apply 120 calendar days prior to the expiration date shown on the certificate of good practices issued under Regulation N ° 194/99, the verification of good manufacturing practice in terms of ANMAT No. 3266 / 13.