DNV joins technical cooperation programme for medical devices (TCP III)

DNV has been accepted as a designated notified body in the Technical Cooperation Programme on Exchange of Medical Device Quality Management System Regulation and ISO 13485 Audit Reports (TCP III).  

SHARE:

The initiative allows for the exchange of medical device quality management system (QMS) regulatory audit reports between EU notified bodies and the Taiwan Food and Drug Administration authorized medical device QMS auditing organizations.

The key goal is to streamline regulatory processes, enabling faster access for medical device manufacturers to both Taiwanese and European markets. By reducing barriers, the programme accelerates the approval process, allowing companies to bring their products to market more swiftly and efficiently.

Another significant benefit of TCP III is its ability to minimize duplicate audits. By recognizing and accepting audit reports from both regions, the programme saves manufacturers considerable time and resources.

Additionally, TCP III promotes the harmonization of standards, ensuring that safety and quality requirements are consistently met. This harmonization not only benefits manufacturers but also enhances public health protection and strengthens trust in medical devices.

As a participant in TCP III, DNV plays a critical role in several key areas:

1.     Audit Report Exchange:

DNV actively contributes to the exchange of ISO 13485 and Medical Device QMS audit reports.

The efforts are focussed on aligning Taiwan’s regulatory practices with those of the European Union, promoting consistency and efficiency.

2.     Regulatory Harmonization:

DNV engages in harmonizing medical device regulations, ensuring they meet international standards and best practices.

3.     Quality Assurance and Safety:

DNV’s participation enhances the quality assurance and safety of medical devices, benefitting both the medical industry and end-users.

4.     International Collaboration:

DNV will collaborate with regulatory bodies, industry stakeholders, and international organizations, to foster an integrated and efficient regulatory environment.

"TCP III's framework is pivotal in accelerating market entry for new medical devices, which is crucial for driving innovation and meeting the growing demand for high-quality and we are honoured to be part of this significant initiative,” said Cecilie Gudesen Torp, Global Director Medical Services, Supply Chain & Product Assurance at DNV. “Our involvement underscores DNV’s commitment to meet the highest international standards and regulatory practices for product safety, quality, and efficiency. We look forward to contributing to the successful implementation of TCP III and fostering stronger international cooperation between Taiwan and the European Union."