The tensiometer is a instrument to measure blood pressure indirectly. In this case it was identified as “Jziki Intelligent Type by totally automatic microcomputer ARM Style ZK-B869 XC Made in China“
In addition, it was detected in an inspection carried out by the Market Control Department In a place in the Buenos Aires Citywhere the corresponding lack of qualifications was found.
Why Anmat prohibited the device
During the inspection, it was verified that The device had no lot numberimporter or manufacturer data. In addition, after consulting the Anmat Helena system, it was confirmed that it was not registered in the National Registry of Producers and medical technology products (RPPTM).
According to the agency, being a device without certification, Its characteristics, functionality and security are unknownwhich represents a Public health risksince erroneous readings can induce wrong medical decisions with serious consequences.
Therefore, and with the aim of preventing potential damages for users, the ANMAT ordered the Prohibition of use and marketing of the product throughout the country. At the same time, the situation reported to Ministry of Health of the Nation and the corresponding health authorities.
ANMAT established procedures to import and export food
The National Drug Administration, Food and Medical Technology (ANMAT) made available the new procedures and procedures that are managed through the Inal for the importation of food for commercialization, or for exclusively industrial use of the establishment (UPEI), or samples without commercial value or packaging and utensils in contact with food, according to their origin and, the procedures for export, of being required by the country of destination.
The products that are imported from individualized countries in the Annex III (IF-2024-129062333-APN-SSE#MDYTE) to Decree 2126/71 and its amendments, may be entered into the country and marketed presenting a sworn statement by making the “Import notice” corresponding through the Tad platform
Some of these nations considered with high health surveillance standards or with which there are economic integration treaties or reciprocity agreements are: Australia, Canada, Switzerland, United States, New Zealand, Israel, Japan, United Kingdom of Great Britain and Ireland of the North, and the European Union.
Source: Ambito
