Product safety and efficiency for healthcare class I and class II

CENIC Laboratory detains accreditation by INMETRO’s CGCRE and is REBLAS qualified for tests on surgical instruments which are medical products generally classified as class I or II.
RDC 40 of August 2015 which defines the register requirements of medical products, shows in its annex II the necessity of a technical dossier for medical products class I and II.
According to information as per annex II, this dossier does not need to be protocolled by ANVISA, but must remain in possession of the register’s owner. The dossier may be the object of monitoring. In specific cases of checking and investigation the handing over of the technical dossier may be requested by Anvisa.

Table of annex II of RDC 40 shows the documents which must figure in this dossier, among them the following:
. List of technical standards
. Physical  / mechanical properties
. Material / chemical properties

The list of standards depends on each product; by consulting ABNT’s site the manufacturer will be able to learn which standards are better suited for his products.

Consult the list of tests performed by CENIC Lab on surgical instruments.