Disposition D.N.C.I. Nº 977/99

SEEN Resolution of the Ministry of Industry, Trade and Mining No. 92 of 16 February 1998 and the provision of this National No. 499, of April 28, 1999, and WHEREAS:
That provision established on September 18, 1999 as the date of entry into force of the second stage of implementation of Resolution SIC & MN 92/98 for electronic products.
Electromedical devices that generally have between its constituent parts electronics.
That, in turn, are a category with specific characteristics within the universe of electrical products.
The National Administration of Drugs, Food and Medical Technology is responsible for the verification of this type of equipment, in terms of benefits.
That, together with such agency, the National Directorate is analyzing specific regulations about electrical safety.
That until put into effect such customization, it is appropriate to keep these teams under the requirements of the first stage of implementation of Resolution SIC & MN 92/98.
That, however, is desirable the participation of Administration National Drug, Food and Medical Technology in reviewing the Affidavits of Compliance Product to be presented in compliance with this instance.
That this is issued in exercise of the powers conferred by Article 10 of Resolution of the Ministry of Industry, Trade and Mining No. 524, of August 20, 1998.
Thus,
NATIONAL DIRECTOR OF COMMERCE HAS INTERIOR:
Article 1 .- Suspéndese until December 18, 1999 the date of commencement of the term of the second stage of implementation of Resolution No. 92/98 SIC & M. equipment intended for therapeutic or diagnostic purposes in human medicine .
Article 2 .- Since the enactment of this provision and to date established by the previous article, Affidavits of Compliance Product to be filed with the National Directorate in fulfillment of the first stage of implementation of Resolution SIC & M. No. 92/98, must have their form “B” previously made by the National Administration of Drugs, Food and Medical Technology.
Article 3 .- This provision shall take effect from the date of its publication in the Official Gazette.
Article 4 .- communicated, published, submitted to the National Official Registry and filed.