PMC Regulation Consulting

In Italy, products marketed as disinfectants, insecticides, insect repellents, rodenticides, and raticides are defined as medical devices (PMCs) and can only be placed on the market if the competent authority deems that they meet the requirements defined by the regulatory framework, namely DPR 392/1998 and subsequent provisions.

PMCs play a crucial role in numerous sectors, from healthcare to the food industry. Their production and marketing are subject to strict regulations to ensure consumer safety and product efficacy.

To successfully navigate the complex regulatory landscape of medical-surgical devices, our company offers a highly specialized PMC regulatory consultancy service. Our team of experts is prepared to provide comprehensive assistance, from the initial assessment of applicable regulations to managing all stages of the authorization process. We are committed to ensuring that our clients not only comply with current regulations but are also well-positioned to promptly respond to any legislative changes, minimizing legal risks and protecting their market reputation. Relying on our consultancy means choosing a reliable and competent partner in the field of medical-surgical devices.

The complexity of PMC regulations requires companies to carefully evaluate and manage authorization procedures. Non-compliance with regulatory provisions may result in:

• Administrative and criminal penalties
• Withdrawal of non-compliant products from the market
• Damage to the company's image

To address the challenges posed by PMC regulation, it is essential to rely on expert consultants who can:

• Analyze specific regulations: Assess the applicability of different regulatory provisions to the product in question.
• Prepare technical documentation: Prepare all the documentation necessary for the authorization request, ensuring its completeness and conformity.
• Assist in authorization procedures: Accompany the company throughout all phases of the authorization process, providing technical and administrative support.
• Monitor regulatory developments: Keep the company constantly updated on regulatory changes and best practices in the sector.