ECUADOR

On November 29, the National Agency for Regulation, Control and Sanitary Surveillance (ARCSA in Spanish) put in consultation the Guidelines for the registration of Conformity Assessment Bodies (CABs) in the entity. The text establishes the requirements and procedure for the registration of CABs, which include private laboratories, before the ARCSA, with the purpose of performing quality control analysis after the issuance of registrations or notifications on the elaboration of products for human use and consumption. Interested parties may submit their observations until December 1, to the following e-mail: [email protected]. The comments form can be downloaded by clicking here.

The text indicates that the OECs, which can be laboratories, will be used by the sanitary agency for the post-registration or post-notification quality control of products for human use and consumption, in case the amount of samples of such goods exceeds the analytical and technical capacity of a Reference Laboratory or when requested by the highest authorities of ARCSA or other entities that conform the Integral Public Health Network of Ecuador.

Likewise, the text indicates that the sanitary entity will not require the analysis services of the OECs in case the agency contemplates a conflict of interest with the holder of the registry to be controlled, also if the latter does not allow access to its facilities to the ARCSA’s evaluation team to supervise the execution of the laboratory analysis, or if a maximum authority of the agency requires it.