By surgical medical devices (PMC) we mean products disinfectants, insecticides, rat poisons and insect repellents containing an active substance under review (not yet included in the European list).
PMCs can be placed on the Italian market following registration with the Ministry of Health pursuant to Presidential Decree no. 392 of 6 October 1998 and the Provision of 5 February 1999.
In order to apply for authorization
- the active ingredient contained must be under review for the PT (product type) to which it belongs,
- the PMC must be produced in a previously authorized workshop (see article PMC production workshops )
- the effectiveness must be proven with tests performed in accordance with EN standards.
The application for authorization, to be submitted together with the Ministry of Health and the Higher Institute of Health , is accompanied by specific documentation including safety data sheets, label and analysis.
Following the evaluation of the application presented, the surgical medical aids authorized in this way report on the label the words: “Surgical Medical Unit” and “Registration of the Ministry of Health n. … .. “.
If the product contains an active ingredient already approved, it falls within the authorization procedures pursuant to European Regulation no. 528/2012. PMCs already authorized will also have to be authorized as biocidal products when the active substance is approved. For more details see here
Chemicals consulting offers companies wishing to register a PMC with a complete consulting service ranging from the choice of analyzes and efficacy tests to be performed according to the product and its action, to the preparation, transmission of the application and possible interaction with the ministry. The support ends when the authorization is granted.
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